The Effectiveness of rTMS in Depressed VA Patients
Study Details
Study Description
Brief Summary
The purpose of this multi-site trial is to determine if repetitive Transcranial Magnetic Stimulation (rTMS) helps people with depression who have not been helped by medications or who have not been helped enough by medications.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Major depression occurs in about 10% of American outpatients every year and of those, approximately 20% respond incompletely or not at all to trials of antidepressants, mood stabilizers, or psychotherapy (Kaplan and Sadock, 1996; Keller et al 1992; Thase, 2004). Treatment as usual for these cases of treatment resistant major depression (TRMD) frequently involves increased risks and increased side effects, such as those seen in monoamine oxidase inhibitors (MAOIs) and electroconvulsive therapy (ECT). New TRMD treatments are needed, preferably without major safety concerns or side effects as seen with aggressive polypharmacy or ECT.
Repetitive transcranial magnetic stimulation (rTMS) is a method of delivering brain stimulation without the seizures or risks associated with ECT, nor the potential side effects and risks of MAOI therapy. Systematic review and meta-analysis of the studies to date, which are typically of a small scale, appear to show a positive effect in TRMD (Martin et al. 2003). With a minimal side effect profile, and the rarity of untoward events and side-effects (Pascual-Leone et al. 1993; Wassermann 1997), safety concerns regarding the use of rTMS are considerably less than with ECT. Given this, rTMS has the potential to be a significant advance in care, if it were shown to be effective in TRMD in VA patients.
The trials of rTMS performed to date have not included participants with comorbid disorders, such as substance abuse and post-traumatic stress disorder (PTSD), thus the generalizability of their findings to a VA population is not clear. Further research including Veterans with possible comorbid disorders is necessary, given the high rates of co-occurring substance abuse and PTSD that is present in the Veteran population.
The present study is a randomized, controlled trial that compares active rTMS to a sham condition in Veterans with treatment resistant major depression and possible comorbid post-traumatic stress disorder (PTSD) and / or a history of substance abuse. Veterans will remain under the care of their VA primary mental health provider throughout the project. Participants will be assessed at pre-, mid- and several post-treatment time points. This is a multisite trial that will be conducted at 9 VA Medical Centers around the country.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Active rTMS Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. |
Device: rTMS
Repetitive Transcranial Magnetic Stimulation
|
| Placebo Comparator: Sham rTMS Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. |
Device: Sham Device
Placebo Device that simulates active rTMS treatment
|
Outcome Measures
Primary Outcome Measures
- The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression [End of acute treatment 4-6 weeks]
The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome.
Secondary Outcome Measures
- Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS) [End of acute treatment 4-6 weeks, then end of F/U 6 months]
To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome.
- Mean Depression Score as Assessed by Beck Depression Inventory (BDI) [Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months]
This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state.
- Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS) [End of acute treatment 4-6 weeks, then end of F/U 6 months]
The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
- Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS) [End of acute treatment 4-6 weeks, then end of F/U 6 months]
The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome.
- Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS) [End of acute treatment 4-6 weeks, then end of F/U 6 months]
As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Between 18 and 80 years of age
-
Using the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM) Disorders (SCID) for DSM-IV-TR (First et al. 2002) patients will be diagnosed Major Depressive Disorder (MDD).
-
Have a Hamilton Rating Scale for Depression (HRSD-24) score greater or equal to 20 no more than 7 days prior to randomization.
-
Exhibit moderate level of resistance to antidepressant treatment defined, using the Antidepressant Treatment History Form (ATHF) (Sackeim et al. 1990), as failure of at least two adequate medication trials.
-
Duration of current episode of less than or equal to 10 years.
-
Ability to obtain a Motor Threshold (MT) (should be determined at the end of the screening process).
-
Currently under the care of a VA psychiatrist.
-
If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to randomization and patient will be willing to remain on a stable regimen during the acute treatment phase.
-
Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.
-
For female participants, agrees to use one of the following acceptable methods of birth control
-
Complete abstinence (not having sexual intercourse with anyone)
-
An oral contraceptive (birth control pills)
-
Norplant
-
Depo-Provera
-
A condom with spermicide
-
A cervical cap with spermicide
-
A diaphragm with spermicide
-
An Intrauterine device
-
Surgical sterilization (having tubes tied)
-
Able to read, verbalize understanding and voluntarily sign the Informed Consent Form prior to performance of any study-specific procedures or assessments.
Exclusion Criteria:
-
Pregnant or lactating female (This is an FDA-required exclusion. In the future, if rTMS becomes a proven treatment for major depression, its safety in the context of pregnancy should be studied separately (Nahas et al. 1999).
-
Unable to be safely withdrawn, at least two-weeks prior to treatment commencement, from medications that substantially increase the risk of having seizures. For the purpose of this study, those medications are listed in Appendix G (for example, theophylline).
-
Have a cardiac pacemaker.
-
Have an implanted device (deep brain stimulation) or metal in the brain.
-
Have a cochlear implant.
-
Have a mass lesion, cerebral infarct, increased intracranial pressure, or other active central nervous system (CNS) disease, including a seizure disorder.
-
Known current psychosis as determined by DSM-IV or SCID (axis I, psychotic disorder, schizophrenia) or a history of a non-mood psychotic disorder.
-
Known current Bipolar I disorder as determined by SCID or a History of Bipolar I disorder.
-
Current amnestic disorders, dementia, Blessed Orientation-Memory-Concentration (BOMC) greater than 10, delirium, or other cognitive disorders.
-
Current substance abuse (not including caffeine or nicotine) as determined by positive toxicology screen, or by history via SCID, within 3 months prior to screening.
-
Patients with an elevated risk of seizure due to traumatic brain injury (TBI).
-
Participation in another concurrent clinical trial.
-
Patients with prior exposure to rTMS.
-
Active current suicidal intent or plan as evidenced by a score of 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale (C-SSRS) or the endorsement of an actual attempt, interrupted attempt, or an aborted attempt in the past 6 months. All patients will be required to establish a written safety plan involving their primary psychiatrist and the treatment team before entering the clinical trial (See Section X.B.8).
-
Unstable cardiac disease or recent (< 3 months previous) myocardial infarction.
-
Patient refuses to sign consent for participation in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | United States | 94304-1290 |
| 2 | San Francisco VA Medical Center, San Francisco, CA | San Francisco | California | United States | 94121 |
| 3 | Cincinnati VA Medical Center, Cincinnati, OH | Cincinnati | Ohio | United States | 45220 |
| 4 | Philadelphia VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania | United States | 19104 |
| 5 | VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA | Pittsburgh | Pennsylvania | United States | 15240 |
| 6 | Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | United States | 29401-5799 |
| 7 | Central Texas Veterans Health Care System, Temple, TX | Temple | Texas | United States | 76504 |
| 8 | VA Salt Lake City Health Care System, Salt Lake City, UT | Salt Lake City | Utah | United States | 84148 |
| 9 | White River Junction VA Medical Center, White River Junction, VT | White River Junction | Vermont | United States | 05009-0001 |
Sponsors and Collaborators
- VA Office of Research and Development
Investigators
- Study Chair: Jerome A. Yesavage, MD, VA Palo Alto Health Care System, Palo Alto, CA
Study Documents (Full-Text)
More Information
Publications
- 556
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Active rTMS | Sham rTMS |
|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Period Title: Overall Study | ||
| STARTED | 81 | 83 |
| COMPLETED | 60 | 65 |
| NOT COMPLETED | 21 | 18 |
Baseline Characteristics
| Arm/Group Title | Active rTMS | Sham rTMS | Total |
|---|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment | Total of all reporting groups |
| Overall Participants | 81 | 83 | 164 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
55.6
(12.2)
|
54.8
(12.6)
|
55.2
(12.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
14
17.3%
|
18
21.7%
|
32
19.5%
|
| Male |
67
82.7%
|
65
78.3%
|
132
80.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
2
2.5%
|
0
0%
|
2
1.2%
|
| Asian |
1
1.2%
|
3
3.6%
|
4
2.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
12
14.8%
|
14
16.9%
|
26
15.9%
|
| White |
63
77.8%
|
63
75.9%
|
126
76.8%
|
| More than one race |
3
3.7%
|
2
2.4%
|
5
3%
|
| Unknown or Not Reported |
0
0%
|
1
1.2%
|
1
0.6%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
81
100%
|
83
100%
|
164
100%
|
| Beck Scale for Suicide Ideation (BSI) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
3.7
(6.0)
|
5.6
(6.7)
|
4.7
(6.5)
|
| Beck Depression Inventory (BDI) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
22.6
(10.3)
|
26.5
(10.0)
|
24.5
(10.3)
|
| VR-36 Mental Component Summary (MCS) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
27.2
(11.6)
|
25.1
(10.0)
|
26.2
(10.8)
|
| VR-36 Physical Component Summary (PCS) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
42.4
(11.5)
|
40.2
(10.0)
|
41.3
(10.8)
|
| Montgomery Asberg Depression Rating Scale (MADRS) (units on a scale) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [units on a scale] |
24.7
(7.6)
|
26.2
(6.9)
|
25.5
(7.3)
|
Outcome Measures
| Title | The Proportion of Participants Achieving Remission From Depression as Assessed by Hamilton Rating Scale for Depression |
|---|---|
| Description | The primary outcome is a proportion of participants achieving remission from depression based on the HRSD24 less than or equal to 10 at the end of the acute treatment phase. 24 item Instrument with overall score range from 0 - 76. High values represent a worse outcome. |
| Time Frame | End of acute treatment 4-6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT |
| Arm/Group Title | Active rTMS | Sham rTMS |
|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Measure Participants | 81 | 83 |
| Count of Participants [Participants] |
33
40.7%
|
31
37.3%
|
| Title | Mean Suicidal Ideation Score as Assessed by Beck Scale for Suicide Ideation (BSS) |
|---|---|
| Description | To help clinicians screen psychiatric patients for suicidal ideation, the Beck Scale for Suicide Ideation was developed, and is herein referred to as the BSS. This self-report measure consists of 21 items with overall score range from 0 - 38, with the last two items not counted in scoring. A high score represents a worse outcome. |
| Time Frame | End of acute treatment 4-6 weeks, then end of F/U 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT minus participants with missing values |
| Arm/Group Title | Active rTMS | Sham rTMS |
|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Measure Participants | 67 | 72 |
| End of Acute Treatment |
2.0
(4.6)
|
2.7
(4.9)
|
| End of F/U |
1.5
(4.2)
|
2.5
(4.9)
|
| Title | Mean Depression Score as Assessed by Beck Depression Inventory (BDI) |
|---|---|
| Description | This measure is a 21-item self-report test presented in a multiple choice format which measures presence and extent of depression with overall score range from 0 - 63. A higher score represents a worse outcome. Each of the 21 items addresses a specific symptom or attitude that pertains to depressed patients, and which are consistent with descriptions of the depression within the peer-reviewed literature. While generally deemed less reliable than scales score by a trained rater (for example, the HRSD), the Beck scale is easy to administer, and provides convenient means by which patients can effectively communicate their own perception of their mood state. |
| Time Frame | Baseline - end of acute treatment 4-6 weeks, then end of F/U 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT minus participants with missing values |
| Arm/Group Title | Active rTMS | Sham rTMS |
|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Measure Participants | 66 | 72 |
| End of Acute Treatment |
14.2
(10.9)
|
13.0
(9.5)
|
| End of F/U |
9.0
(8.3)
|
12.8
(10.8)
|
| Title | Mean Mental Component Score as Assessed by VR-36 Mental Component Summary (MCS) |
|---|---|
| Description | The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). MCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome. |
| Time Frame | End of acute treatment 4-6 weeks, then end of F/U 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT minus participants with missing values |
| Arm/Group Title | Active rTMS | Sham rTMS |
|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Measure Participants | 68 | 73 |
| End of Acute Treatment |
35.1
(14.3)
|
36.0
(14.7)
|
| End of F/U |
34.5
(12.8)
|
34.8
(13.4)
|
| Title | Mean Physical Component Score as Assessed by VR-36 Physical Component Summary (PCS) |
|---|---|
| Description | The VR-36 is a self-administered survey that measures eight dimensions of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS). PCS is analyzed in this section. Standardized scoring ranging from 0-100. A higher score represents a better outcome. |
| Time Frame | End of acute treatment 4-6 weeks, then end of F/U 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT minus participants with missing values |
| Arm/Group Title | Active rTMS | Sham rTMS |
|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Measure Participants | 68 | 73 |
| End of Acute Treatment |
41.9
(10.9)
|
41.2
(11.9)
|
| End of F/U |
42.8
(10.8)
|
40.1
(12.3)
|
| Title | Mean Depression Score as Assessed by the Montgomery Asberg Depression Rating Scale (MADRS) |
|---|---|
| Description | As another measure of depression, the Montgomery-Asberg Depression Rating Scale (MADRS) has been used with increasing frequency in recent years to measure outcome in antidepressant efficacy trials. It offers an alternative view of depressive illness, and may be sensitive to depressive symptoms that are not easily captured in the context of the HRSD, such as hypersomnia, increased appetite, and concentration/indecision. The MADRS is a 10-item clinician rating of depressive symptoms. Each item is scored on a 7-point scale (0 to 6) (range 0-60). A high score represents a worse outcome. |
| Time Frame | End of acute treatment 4-6 weeks, then end of F/U 6 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT minus participants with missing values |
| Arm/Group Title | Active rTMS | Sham rTMS |
|---|---|---|
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment |
| Measure Participants | 70 | 74 |
| End of Acute Treatment |
14.3
(11.1)
|
13.1
(10.5)
|
| End of F/U |
13.7
(10.2)
|
15.0
(9.7)
|
Adverse Events
| Time Frame | From informed consent until termination. 7-8 months. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Active rTMS | Sham rTMS | ||
| Arm/Group Description | Those receiving experimental treatment will receive 20 to 30 sessions of rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. rTMS: Repetitive Transcranial Magnetic Stimulation | Those receiving the sham rTMS will receive 20 to 30 sessions of sham rTMS in blocks of 5 sessions. The treatment will be delivered by trained medical personnel. Sham Device: Placebo Device that simulates active rTMS treatment | ||
All Cause Mortality |
||||
| Active rTMS | Sham rTMS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/81 (0%) | 0/83 (0%) | ||
Serious Adverse Events |
||||
| Active rTMS | Sham rTMS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 22/81 (27.2%) | 18/83 (21.7%) | ||
| Cardiac disorders | ||||
| Arrhythmia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Coronary artery disease | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Ear and labyrinth disorders | ||||
| Hypoacusis | 2/81 (2.5%) | 2 | 2/83 (2.4%) | 2 |
| Gastrointestinal disorders | ||||
| Pancreatitis | 1/81 (1.2%) | 2 | 0/83 (0%) | 0 |
| General disorders | ||||
| Chest discomfort | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Chest pain | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Drug withdrawal syndrome | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Hernia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Gallbladder disorder | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Immune system disorders | ||||
| Allergy to arthropod sting | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Infections and infestations | ||||
| Gastroenteritis viral | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Orchitis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Staphylococcal infection | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Viral infection | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Alcohol poisoning | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Accidental overdose | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Fall | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Road traffic accident | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Investigations | ||||
| Acoustic stimulation tests abnormal | 4/81 (4.9%) | 4 | 5/83 (6%) | 5 |
| Metabolism and nutrition disorders | ||||
| Hyperglycaemia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Arthralgia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Clear cell renal cell carcinoma | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Nervous system disorders | ||||
| Transient ischaemic attack | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Psychiatric disorders | ||||
| Suicidal ideation | 4/81 (4.9%) | 4 | 4/83 (4.8%) | 4 |
| Depression | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Suicide attempt | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Anxiety | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Depressed mood | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Depression suicidal | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Mania | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Obsessive-compulsive disorder | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Persistent depressive disorder | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Post-traumatic stress disorder | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Pleuritic pain | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Pulmonary embolism | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Vascular disorders | ||||
| Hypotension | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| Active rTMS | Sham rTMS | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 71/81 (87.7%) | 69/83 (83.1%) | ||
| Blood and lymphatic system disorders | ||||
| Lymphadenopathy | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Cardiac disorders | ||||
| Arrhythmia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Congenital, familial and genetic disorders | ||||
| Arnold-Chiari malformation | 1/81 (1.2%) | 3 | 0/83 (0%) | 0 |
| Ear and labyrinth disorders | ||||
| Hypoacusis | 1/81 (1.2%) | 1 | 4/83 (4.8%) | 4 |
| Tinnitus | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 3 |
| Ear pain | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Vertigo | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Deafness neurosensory | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Endocrine disorders | ||||
| Thyroid mass | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Eye disorders | ||||
| Vision blurred | 3/81 (3.7%) | 3 | 0/83 (0%) | 0 |
| Blindness | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Conjunctivitis allergic | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Diabetic retinopathy | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Episcleritis | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Glaucoma | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Photophobia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Photopsia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Visual impairment | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Gastrointestinal disorders | ||||
| Toothache | 3/81 (3.7%) | 3 | 2/83 (2.4%) | 2 |
| Abdominal discomfort | 1/81 (1.2%) | 1 | 3/83 (3.6%) | 3 |
| Diarrhoea | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Gastrooesophageal reflux disease | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Abdominal pain | 0/81 (0%) | 0 | 2/83 (2.4%) | 2 |
| Constipation | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Dental caries | 0/81 (0%) | 0 | 2/83 (2.4%) | 2 |
| Dyspepsia | 0/81 (0%) | 0 | 2/83 (2.4%) | 2 |
| Nausea | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Vomiting | 0/81 (0%) | 0 | 2/83 (2.4%) | 2 |
| Abdominal distension | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Abdominal hernia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Anal fistula | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Aphthous ulcer | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Diverticulum intestinal | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Flatulence | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Gastrointestinal disorder | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Gastrointestinal pain | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Inguinal hernia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Oesophageal achalasia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Retching | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Umbilical hernia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| General disorders | ||||
| Pain | 3/81 (3.7%) | 3 | 4/83 (4.8%) | 4 |
| Adverse drug reaction | 2/81 (2.5%) | 2 | 2/83 (2.4%) | 2 |
| Chest pain | 3/81 (3.7%) | 3 | 1/83 (1.2%) | 1 |
| Fatigue | 2/81 (2.5%) | 2 | 1/83 (1.2%) | 1 |
| Influenza like illness | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Pyrexia | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Drug withdrawal syndrome | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Nodule | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Sensation of blood flow | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Sensation of foreign body | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Swelling | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Ulcer | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Hepatobiliary disorders | ||||
| Biliary dyskinesia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Hepatocellular injury | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Immune system disorders | ||||
| Seasonal allergy | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Hypersensitivity | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Infections and infestations | ||||
| Nasopharyngitis | 8/81 (9.9%) | 8 | 8/83 (9.6%) | 12 |
| Upper respiratory tract infection | 4/81 (4.9%) | 4 | 4/83 (4.8%) | 5 |
| Gastroenteritis | 4/81 (4.9%) | 5 | 1/83 (1.2%) | 1 |
| Sinusitis | 1/81 (1.2%) | 2 | 3/83 (3.6%) | 3 |
| Influenza | 1/81 (1.2%) | 2 | 2/83 (2.4%) | 2 |
| Bronchitis | 2/81 (2.5%) | 2 | 1/83 (1.2%) | 1 |
| Carbuncle | 0/81 (0%) | 0 | 2/83 (2.4%) | 3 |
| Cellulitis | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Tooth abscess | 2/81 (2.5%) | 2 | 1/83 (1.2%) | 1 |
| Urinary tract infection | 0/81 (0%) | 0 | 3/83 (3.6%) | 3 |
| Epididymitis | 1/81 (1.2%) | 2 | 0/83 (0%) | 0 |
| Pilonidal cyst | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Bacterial infection | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Conjunctivitis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Folliculitis | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Furuncle | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Hordeolum | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Infection | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Laryngitis | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Oral bacterial infection | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Oral herpes | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Pharyngitis streptococcal | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Pneumonia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Respiratory tract infection | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Skin infection | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Tooth infection | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Vaginitis gardnerella | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Viral infection | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Viral upper respiratory tract infection | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Injury, poisoning and procedural complications | ||||
| Fall | 3/81 (3.7%) | 4 | 6/83 (7.2%) | 6 |
| Animal bite | 0/81 (0%) | 0 | 2/83 (2.4%) | 3 |
| Limb injury | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Exposure to toxic agent | 1/81 (1.2%) | 2 | 0/83 (0%) | 0 |
| Ligament sprain | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Road traffic accident | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Animal scratch | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Arthropod bite | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Arthropod sting | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Contusion | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Ear canal abrasion | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Fibula fracture | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Foot fracture | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Incorrect dosage administered | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Laceration | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Muscle strain | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Penis injury | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Post-traumatic neck syndrome | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Stoma obstruction | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Tooth injury | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Upper limb fracture | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Wound | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Investigations | ||||
| Acoustic stimulation tests abnormal | 16/81 (19.8%) | 18 | 16/83 (19.3%) | 19 |
| Colonoscopy | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Alanine aminotransferase increased | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Blood thyroid stimulating hormone increased | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Ejection fraction decreased | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Hepatic enzyme increased | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Protein total decreased | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Metabolism and nutrition disorders | ||||
| Hypoglycaemia | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Dehydration | 0/81 (0%) | 0 | 2/83 (2.4%) | 2 |
| Gout | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Diabetes mellitus inadequate control | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Muscle spasms | 2/81 (2.5%) | 2 | 4/83 (4.8%) | 5 |
| Arthralgia | 4/81 (4.9%) | 4 | 2/83 (2.4%) | 2 |
| Back pain | 2/81 (2.5%) | 2 | 4/83 (4.8%) | 4 |
| Arthritis | 2/81 (2.5%) | 2 | 1/83 (1.2%) | 1 |
| Muscle twitching | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Pain in extremity | 0/81 (0%) | 0 | 3/83 (3.6%) | 3 |
| Trigger finger | 1/81 (1.2%) | 1 | 2/83 (2.4%) | 2 |
| Exostosis | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Flank pain | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Musculoskeletal pain | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Rotator cuff syndrome | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Bursitis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Cervical spinal stenosis | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Chest wall mass | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Intervertebral disc degeneration | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Joint effusion | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Musculoskeletal chest pain | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Myalgia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Neck pain | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Osteoarthritis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Rhabdomyolysis | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Spinal osteoarthritis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Synovial cyst | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Temporomandibular joint syndrome | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||
| Malignant melanoma in situ | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Pituitary tumour benign | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Skin cancer | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 15/81 (18.5%) | 25 | 16/83 (19.3%) | 25 |
| Dizziness | 2/81 (2.5%) | 2 | 3/83 (3.6%) | 3 |
| Balance disorder | 0/81 (0%) | 0 | 2/83 (2.4%) | 2 |
| Sinus headache | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Ataxia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Facial paralysis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Hypoaesthesia | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Loss of consciousness | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Memory impairment | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Migraine | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Mononeuropathy | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Paraesthesia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Phantom pain | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Radiculopathy | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Sensory disturbance | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Speech disorder | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Syncope | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Tension headache | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Tremor | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Visual field defect | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Psychiatric disorders | ||||
| Depression | 6/81 (7.4%) | 7 | 2/83 (2.4%) | 2 |
| Anxiety | 4/81 (4.9%) | 4 | 2/83 (2.4%) | 2 |
| Insomnia | 3/81 (3.7%) | 3 | 1/83 (1.2%) | 1 |
| Agitated depression | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Bipolar disorder | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Confusional state | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Derealisation | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Dissociation | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Flashback | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Mood altered | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Panic attack | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Parasomnia | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Post-traumatic stress disorder | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Suicidal ideation | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Renal and urinary disorders | ||||
| Incontinence | 2/81 (2.5%) | 3 | 0/83 (0%) | 0 |
| Dysuria | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Urinary retention | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Acute kidney injury | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Nephrolithiasis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Urinary incontinence | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Urinary tract obstruction | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Reproductive system and breast disorders | ||||
| Erectile dysfunction | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Dyspnoea | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Epistaxis | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Oropharyngeal pain | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Sleep apnoea syndrome | 2/81 (2.5%) | 2 | 0/83 (0%) | 0 |
| Chronic obstructive pulmonary disease | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Cough | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Haemoptysis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Hiccups | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Nasal congestion | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Respiratory tract congestion | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Rhinorrhoea | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| Rash | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Urticaria | 1/81 (1.2%) | 2 | 0/83 (0%) | 0 |
| Dermatitis contact | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Ecchymosis | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Eczema | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Ingrowing nail | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Pain of skin | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Rash pruritic | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Skin discolouration | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Skin discomfort | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Skin reaction | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Skin ulcer | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Surgical and medical procedures | ||||
| Tooth extraction | 1/81 (1.2%) | 1 | 1/83 (1.2%) | 1 |
| Dental care | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Elective procedure | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Papilloma excision | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Shoulder operation | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
| Vascular disorders | ||||
| Deep vein thrombosis | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Hypertension | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Lymphoedema | 0/81 (0%) | 0 | 1/83 (1.2%) | 1 |
| Orthostatic hypotension | 1/81 (1.2%) | 1 | 0/83 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Jerome Yesavage, MD |
|---|---|
| Organization | Director, VISN21 MIRECC, Department of Veterans Affairs |
| Phone | 650-852-3287 |
| Jerome.Yesavage@va.gov |
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