Transcranial Magnetic Stimulation to Improve Speech in Aphasia

• Sponsor: Boston University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00608582
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH), Harvard Medical School (HMS and HSDM) (Other), University of Pennsylvania (Other)
• Enrollment: 63
• Locations: 3
• Arms: 2
• Duration (Months): 131
• Patients Per Site: 21
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to examine whether repetitive transcranial magnetic stimulation (rTMS) can be used to improve speech in chronic stroke patients with aphasia. Aphasia patients can have problems with speech production. The rTMS procedure allows painless, noninvasive stimulation of human cortex from outside the head.

Chronic aphasia patients have been observed in our functional magnetic resonance brain imaging studies to have excess brain activation in brain areas possibly related to language on the right side of the brain (opposite side to where the stroke took place). It is expected that suppression of activity in the directly targeted brain region will have an overall modulating effect on the neural network for naming (and propositional speech) and will result in behavioral improvement.

Condition or Disease	Intervention/Treatment	Phase
Aphasia; Cerebrovascular Stroke	Device: Transcranial Magnetic Stimulation, Repetitive	Phase 1

Detailed Description

OBJECTIVE: The purpose of this research is to investigate whether repetitive transcranial magnetic stimulation (rTMS) can improve speech in chronic stroke patients with aphasia. TMS allows painless, noninvasive stimulation of brain cortex (1 cm x 1 cm). Slow (1 Hz) rTMS appears to decrease excitability in the targeted cortical region of interest (ROI) leading to measurable behavioral effects. Chronic aphasia patients have been observed in our fMRI work (and others) to have increased activation in right (R) Broca's and other R language homologues during language tasks. It is hypothesized that suppression of activity in a directly targeted right hemisphere (RH) ROI will have an overall modulating effect on functionally connected elements of the distributed neural network for naming (and propositional speech), and will result in behavioral improvement.

RESEARCH PLAN AND METHODS:

Nonfluent aphasia patients (>6 Mo. poststroke) will be studied. The rTMS treatments in Boston take place at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School under the supervision of Alvaro Pascual-Leone, M.D., Ph.D. and additional patients will be studied at the Hospital of the University of Pennsylvania, H. Branch Coslett, M.D., who is a P.I. on that subcontract. This is a blinded, randomized, sham-control, incomplete crossover design. Naming and language tests are obtained pre- and post- rTMS.

Treatment Design: Multiple Baseline Language Evaluations (x3) are performed at Entry (Boston Naming Test, BNT; and Boston Diagnostic Aphasia Exam, BDAE). Primary Outcome Measures are BNT; and Number of Words per Longest Phrase Length (cookie theft picture description) from the BDAE. Patients are randomly assigned to receive a series of either Sham rTMS followed by a series of Real rTMS; OR they receive only the series of Real rTMS. The Sham series is identical to the Real, however, no magnetic pulse is emitted from the coil, although the patient hears the same clicking sound emitted from the coil. Due to space limitation here, only the Real rTMS treatment schedule is described.

There are two rTMS Phases: During Phase 1, the single, best RH cortical ROI to suppress with rTMS to improve picture naming, is determined for each patient. Real rTMS (1 Hz, 90% motor threshold) is applied for 10 minutes, in separate rTMS sessions, to each of 4 different RH cortical ROIs (R ant. BA 45; R post. BA 45; R BA 44 and R M1, mouth). Snodgrass & Vanderwart (S&V, 1980) Picture Naming is tested immediately before and after each ROI has been suppressed with rTMS. The single RH ROI which is associated with at least a 2 SD improvement (above S&V Naming, tested 3x at Baseline), immediately following 10 minutes of rTMS to suppress that cortical area, is considered to be the Best Response ROI for that patient. During Phase 2, the Best Response ROI from Phase 1 is suppressed for 20 minutes, 5 days per week, 2 weeks. All patients receive follow-up BNT and BDAE testing at 2 months following the 10th Real (or Sham) rTMS treatment.

Study Design

• Study Type: Interventional
• Actual Enrollment: 63 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Transcranial Magnetic Stimulation to Improve Speech
• Study Start Date: Jul 1, 2002
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Real rTMS These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS), treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.	Device: Transcranial Magnetic Stimulation, Repetitive; 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
Sham Comparator: Sham rTMS Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS treatments are identical to the Real rTMS treatments, however, no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.	Device: Transcranial Magnetic Stimulation, Repetitive; 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.

Outcome Measures

Primary Outcome Measures

1. Picture Naming [Baseline and 2 months after the last rTMS treatment session]

   Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures

2. Phrase Length [Baseline and 2 months after the last rTMS treatment session]

   Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Right Handed

• Single, Left Hemisphere Cerebrovascular Stroke

• Must be at least 6 months poststroke onset

• Native Speaker of English

• Clinical Diagnosis of Aphasia

Exclusion Criteria:

• Intracranial metallic body from prior neurosurgical procedure

• Implanted metallic devices: pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit or ventriculoperitoneal shunt

• Past history of seizure within 1 year

• Pregnancy

• History of substance abuse within last 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Boston Healthcare System, Jamaica Plain Campus, Boston University Aphasia Research Center (12-A), 150 So. Huntington Ave.	Boston	Massachusetts	United States	02130
2	Berenson-Allen Center for Noninvasive Brain Stimulation, 330 Brookline Ave, Kirstein Bldg., Dept. of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School	Boston	Massachusetts	United States	02215
3	Department of Neurology, Hospital of the University of Pennsylvania, 3 W. Gates Bldg.	Philadelphia	Pennsylvania	United States	19104-4283

Sponsors and Collaborators

• Boston University
• National Institute on Deafness and Other Communication Disorders (NIDCD)
• Harvard Medical School (HMS and HSDM)
• University of Pennsylvania

Investigators

• Study Chair: Margaret A Naeser, Ph.D., Department of Neurology, Boston University School of Medicine, Boston, MA
• Principal Investigator: H B Coslett, M.D., Department of Neurology, Hospital of the University of Pennsylvania, Philadelphia, PA
• Principal Investigator: Alvaro Pascual-Leone, M.D., Ph.D., Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Aphasia Research Lab of Margaret A. Naeser, Ph.D., VA Boston Healthcare System and Dept. of Neurology, Boston University School of Medicine, Boston, MA
• Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Dept. of Neurology, Harvard Medical School, Boston, MA

Publications

• Chrysikou EG, Hamilton RH. Noninvasive brain stimulation in the treatment of aphasia: exploring interhemispheric relationships and their implications for neurorehabilitation. Restor Neurol Neurosci. 2011;29(6):375-94. doi: 10.3233/RNN-2011-0610. Review.
• Garcia G, Norise C, Faseyitan O, Naeser MA, Hamilton RH. Utilizing repetitive transcranial magnetic stimulation to improve language function in stroke patients with chronic non-fluent aphasia. J Vis Exp. 2013 Jul 2;(77):e50228. doi: 10.3791/50228.
• Hamilton RH, Chrysikou EG, Coslett B. Mechanisms of aphasia recovery after stroke and the role of noninvasive brain stimulation. Brain Lang. 2011 Jul;118(1-2):40-50. doi: 10.1016/j.bandl.2011.02.005. Epub 2011 Apr 2. Review.
• Martin PI, Naeser MA, Ho M, Treglia E, Kaplan E, Baker EH, Pascual-Leone A. Research with transcranial magnetic stimulation in the treatment of aphasia. Curr Neurol Neurosci Rep. 2009 Nov;9(6):451-8. Review.
• Naeser MA, Martin PI, Ho M, Treglia E, Kaplan E, Baker EH, and Pascual-Leone A. Transcranial Magnetic Stimulation and Aphasia Research. Book Chapter, Advances in the Neural Substrates of Language: Toward a Synthesis of Basic Science and Clinical Research. Vol 2: Language Processing in the Brain: Special Populations. Miriam Faust (Ed.), Malden, MA: Wiley-Blackwell, 2012.
• Naeser MA, Martin PI, Ho M, Treglia E, Kaplan E, Bashir S, Pascual-Leone A. Transcranial magnetic stimulation and aphasia rehabilitation. Arch Phys Med Rehabil. 2012 Jan;93(1 Suppl):S26-34. doi: 10.1016/j.apmr.2011.04.026.
• Naeser MA, Martin PI, Treglia E, Ho M, Kaplan E, Bashir S, Hamilton R, Coslett HB, Pascual-Leone A. Research with rTMS in the treatment of aphasia. Restor Neurol Neurosci. 2010;28(4):511-29. doi: 10.3233/RNN-2010-0559. Review.
• Torres J, Drebing D, Hamilton R. TMS and tDCS in post-stroke aphasia: Integrating novel treatment approaches with mechanisms of plasticity. Restor Neurol Neurosci. 2013;31(4):501-15. doi: 10.3233/RNN-130314. Review.

• Responsible Party: Margaret Naeser, Research Professor of Neurology, Boston University
• ClinicalTrials.gov Identifier: NCT00608582
• Other Study ID Numbers: NIH-DC05672; R01DC005672; Boston Medical Ctr IRB-H22484; VA Boston Healthcare IRB-1145
• First Posted: Feb 6, 2008
• Last Update Posted: Jan 31, 2017
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Margaret Naeser, Research Professor of Neurology, Boston University: Transcranial Magnetic Stimulation, Repetitive; TMS; Treat Naming; Aphasia; Chronic Stroke; Randomized, Controlled Trial
• Additional relevant MeSH terms: Stroke; Aphasia

Study Results

Participant Flow

Recruitment Details	July 2002-March 2013. Recruited in hospital setting and outreach with affiliated and local clinics VA Boston Healthcare System, Boston, MA; Hospital of the University of Pennsylvania, Philadelphia, PA
Pre-assignment Detail	Assessed for eligibility by telephone screen, or in-office visit. Assessment included review of medical history. Total Excluded (n = 38) Not meeting inclusion criteria (n = 31) Declined to participate (n = 2) Other reasons (n = 5)

Arm/Group Title	Real rTMS	Sham rTMS
Arm/Group Description	These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.	These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. The patients then receive a series of 10 Real rTMS treatments. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
Period Title: Overall Study
STARTED	14	11
COMPLETED	10	7
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Real rTMS	Sham rTMS	Total
Arm/Group Description	These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.	These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil. The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.	Total of all reporting groups
Overall Participants	14	11	25
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58.1 (7.6)	60.8 (11)	59.28 (9.1)
Gender (Count of Participants)
Female	3 21.4%	2 18.2%	5 20%
Male	11 78.6%	9 81.8%	20 80%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 9.1%	1 4%
Not Hispanic or Latino	14 100%	10 90.9%	24 96%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 7.1%	0 0%	1 4%
White	13 92.9%	11 100%	24 96%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	14 100%	11 100%	25 100%
Months Poststroke Onset (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	66 (40)	51 (37)	59 (39)

Outcome Measures

1. Primary Outcome

Title	Picture Naming
Description	Pictures named correctly on Boston Naming Test (BNT), First 20 Pictures
Time Frame	Baseline and 2 months after the last rTMS treatment session

Outcome Measure Data

Analysis Population Description

Chronic Stroke Patients with Aphasia who receive either a Real rTMS series or a Sham rTMS series

Arm/Group Title	Real rTMS	Sham rTMS
Arm/Group Description	These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.	Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
Measure Participants	10	7
Baseline	10.3 (6.11)	12.57 (5.88)
2 Mo. Post rTMS	12.1 (5.55)	11.14 (3.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Real rTMS, Sham rTMS
	Comments	A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 Mo. Post rTMS treatment) and Group (Real vs. Sham).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.028
	Comments	p<0.05 considered significant
	Method	ANOVA
	Comments	Post-hoc paired t-tests were performed.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Real rTMS
	Comments	Paired, t-tests were performed if the ANOVA yields a significant interaction (p<0.05, two-sided) for Baseline vs. 2 months after last rTMS treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	p<.05 considered significant; Pairwise comparisons not adjusted for multiple comparisons
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Sham rTMS
	Comments	Paired, t-tests were performed if the ANOVA yields a significant interaction (p<0.05, two-sided) for Baseline vs. 2 Mo. after last Sham rTMS treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.237
	Comments	p<0.05 considered significant. Pairwise comparisons were not corrected for multiple comparisons.
	Method	t-test, 2 sided
	Comments

2. Primary Outcome

Title	Phrase Length
Description	Longest Number of Words per Phrase Length, for elicited propositional speech for BDAE Cookie Theft Picture Description
Time Frame	Baseline and 2 months after the last rTMS treatment session

Outcome Measure Data

Analysis Population Description

Chronic Stroke Patients with Aphasia who received either Real rTMS or Sham rTMS

Arm/Group Title	Real rTMS	Sham rTMS
Arm/Group Description	These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.	These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. The patients then receive a series of 10 Real rTMS treatments. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.
Measure Participants	10	7
Baseline	5.2 (3.05)	5.285 (3.35)
2 Mo. Post rTMS	5.7 (3.02)	5.0 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Real rTMS, Sham rTMS
	Comments	A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.414
	Comments	p<0.05 considered significant
	Method	ANOVA
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Real rTMS, Sham rTMS
	Comments	A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.822
	Comments	p<0.05 considered significant
	Method	ANOVA
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Real rTMS, Sham rTMS
	Comments	A repeated measures ANOVA is performed with a significance level of p<0.05 (two-sided). Factors: Time (Baseline vs. 2 months after last rTMS treatment) and Group (Real vs. Sham).
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.835
	Comments	p<0.05 considered significant
	Method	ANOVA
	Comments

Adverse Events

Time Frame	Through entire study period for each participant, up to 1 year
Arm/Group Title	Real rTMS		Sham rTMS
Arm/Group Description	These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment. Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA.		Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
All Cause Mortality
	Real rTMS		Sham rTMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Real rTMS		Sham rTMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	Real rTMS		Sham rTMS
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/11 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.