Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

Sponsor
Spaulding Rehabilitation Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02208466
Collaborator
(none)
44
1
3
57.8
0.8

Study Details

Study Description

Brief Summary

In this study investigator's aim to assess the effect of a type of non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation (rTMS) in conjunction with fluoxetine on motor recovery after stroke.

Condition or Disease Intervention/Treatment Phase
  • Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)
  • Drug: Fluoxetine
  • Device: Sham repetitive transcranial magnetic stimulation (rTMS)
  • Drug: Placebo Fluoxetine
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effects of Contralesional Repetitive Magnetic Stimulation Combined With Fluoxetine on Motor Recovery in Acute Stroke Patients
Study Start Date :
Sep 1, 2014
Actual Primary Completion Date :
Jun 25, 2019
Actual Study Completion Date :
Jun 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Active rTMS/active fluoxetine

Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.

Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.
Other Names:
  • magnetic stimulation, Magstim
  • Drug: Fluoxetine
    Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
    Other Names:
  • Prozac, Sarafem, Ladose, Fontex
  • Experimental: Sham rTMS/active fluoxetine

    Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily.

    Drug: Fluoxetine
    Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
    Other Names:
  • Prozac, Sarafem, Ladose, Fontex
  • Device: Sham repetitive transcranial magnetic stimulation (rTMS)
    Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.
    Other Names:
  • Magstim, magnetic stimulation
  • Experimental: Sham rTMS/placebo fluoxetine

    Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily.

    Device: Sham repetitive transcranial magnetic stimulation (rTMS)
    Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.
    Other Names:
  • Magstim, magnetic stimulation
  • Drug: Placebo Fluoxetine
    Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
    Other Names:
  • Prozac, Sarafem, Ladose, Fontex
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in Motor Function (Jebsen-Taylor Task) [baseline and 90 days]

      Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-constrained hand for the assessments. The sum of the different tasks was used for the analysis. Calculation details: value at 9 months minus value at baseline, change in seconds (adjusted mean difference).

    2. Changes in Fugl-Meyer Assessment (FMA) Scale [baseline and 90 days]

      The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. We used the upper limb motor function subscale: minimum values= 0 ; maximum values= 66. Higher scores mean a better outcome. Changes from baseline to 90 days (value at 90 days minus value at baseline).

    Secondary Outcome Measures

    1. Changes in Cortical Excitability Measures [Baseline and 90 days]

      We will measure cortical excitability using single-pulsed transcranial magnetic stimulation (TMS) before and after stimulation at three different time-points. Changes from baseline to 90 days (value at 90 days minus value at baseline).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Ischemic infarction within the past 2 years post event that has caused hemiparesis or hemiplegia, as self-reported and/or confirmed by medical record.

    • Older than 18 years old.

    • Upper extremity weakness defined as a score of >11 and ≤56 on the arm motor Fugl-Mayer motor scale.

    • Minimal pre-stroke disability defined as a score of <3 in the Modified Rankin Scale.

    • Subjects need to be able to follow directions and participate in 2 hours of testing with short breaks.

    • Subjects need to be able to provide informed consent.

    Exclusion Criteria:
    • Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instruction for motor testing

    • Excessive pain in any joint of the paretic extremity (not applicable to severe stroke subjects), as self reported

    • Contraindications to single pulse TMS (will be used to measure cortical excitability) such as: history of seizures, unexplained loss of consciousness, any metal implants in the head, frequent or severe headaches or neck pain, any other electronic implanted medical devices such as pacemakers, defibrillators, or implant medication pump.

    • Patients who have taken fluoxetine in the past 5 weeks.

    • Patients taking any other SSRI at the time of enrollment or in the previous month.

    • Patients taking any other medication likely to have adverse interaction with SSRIs (all the medications the patient is taking will be carefully reviewed, as noted below in "Monitoring of important drug interactions").

    • Active depression on admission to SRH defined by a score of 24 or higher in the Hamilton Depression Rating Scale (HAM-D)

    • Concurrent medical condition likely to worsen patient's functional status in the next 6 months such as: cancer, terminal heart, kidney or liver disease, as self-reported and/or confirmed by medical record.

    • Pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Spaulding Rehabilitation Hospital Charlestown Massachusetts United States 02129

    Sponsors and Collaborators

    • Spaulding Rehabilitation Hospital

    Investigators

    • Principal Investigator: Felipe Fregni, MD PhD MPH, Spaulding Rehabilitation Hospital

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
    ClinicalTrials.gov Identifier:
    NCT02208466
    Other Study ID Numbers:
    • 2014P001046
    First Posted:
    Aug 5, 2014
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail Please note that from the 44 subjects enrolled, only 27 started (were randomized) as 17 subjects screened out during confirmation of eligibility after signing the consent form (some of the criteria could only be checked after consent).
    Arm/Group Title Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Arm/Group Description Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
    Period Title: Overall Study
    STARTED 9 10 8
    COMPLETED 9 10 8
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine Total
    Arm/Group Description Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days. Total of all reporting groups
    Overall Participants 9 10 8 27
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.22
    (9.39)
    50.5
    (16.57)
    57.38
    (9.96)
    55.03
    (11.97)
    Sex: Female, Male (Count of Participants)
    Female
    4
    44.4%
    5
    50%
    2
    25%
    11
    40.7%
    Male
    5
    55.6%
    5
    50%
    6
    75%
    16
    59.3%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    1
    11.1%
    1
    10%
    3
    37.5%
    5
    18.5%
    White
    8
    88.9%
    9
    90%
    5
    62.5%
    22
    81.5%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%

    Outcome Measures

    1. Primary Outcome
    Title Changes in Motor Function (Jebsen-Taylor Task)
    Description Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-constrained hand for the assessments. The sum of the different tasks was used for the analysis. Calculation details: value at 9 months minus value at baseline, change in seconds (adjusted mean difference).
    Time Frame baseline and 90 days

    Outcome Measure Data

    Analysis Population Description
    Performed by a rater blinded to rTMS and pharmacotherapy performed all assessments
    Arm/Group Title Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Arm/Group Description Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
    Measure Participants 9 10 8
    Mean (95% Confidence Interval) [seconds]
    -214.33
    -50.16
    -117.98
    2. Primary Outcome
    Title Changes in Fugl-Meyer Assessment (FMA) Scale
    Description The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. We used the upper limb motor function subscale: minimum values= 0 ; maximum values= 66. Higher scores mean a better outcome. Changes from baseline to 90 days (value at 90 days minus value at baseline).
    Time Frame baseline and 90 days

    Outcome Measure Data

    Analysis Population Description
    Performed by a rater blinded to rTMS and pharmacotherapy performed all assessments
    Arm/Group Title Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Arm/Group Description Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
    Measure Participants 9 10 8
    Mean (95% Confidence Interval) [units on a scale]
    10.10
    6.73
    15.55
    3. Secondary Outcome
    Title Changes in Cortical Excitability Measures
    Description We will measure cortical excitability using single-pulsed transcranial magnetic stimulation (TMS) before and after stimulation at three different time-points. Changes from baseline to 90 days (value at 90 days minus value at baseline).
    Time Frame Baseline and 90 days

    Outcome Measure Data

    Analysis Population Description
    Performed by a rater blinded to rTMS and pharmacotherapy performed all assessments
    Arm/Group Title Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Arm/Group Description Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
    Measure Participants 9 10 8
    Mean (95% Confidence Interval) [motor evoked potential (mV)]
    -0.05
    -0.12
    0.33

    Adverse Events

    Time Frame 3 months
    Adverse Event Reporting Description adverse effects were collected with a questionnaire for adverse effects
    Arm/Group Title Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Arm/Group Description Subjects in this arm will undergo 10 daily sessions over 15 days of active low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of active low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Active Repetitive Transcranial Magnetic Stimulation (rTMS): Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of active fluoxetine by mouth daily. Fluoxetine: Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Subjects in this arm will undergo 10 daily sessions over 15 days of sham low-frequency rTMS with each session lasting 20 minutes. This will be followed by 8 weekly sessions of sham low-frequency rTMS with each session lasting 20 minutes. Additionally, during this time beginning with enrollment, subjects will also be taking 20mg of placebo fluoxetine by mouth daily. Sham repetitive transcranial magnetic stimulation (rTMS): Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered. Placebo Fluoxetine: Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
    All Cause Mortality
    Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/10 (0%) 0/8 (0%)
    Serious Adverse Events
    Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/9 (0%) 0/10 (0%) 0/8 (0%)
    Other (Not Including Serious) Adverse Events
    Active rTMS/Active Fluoxetine Sham rTMS/Active Fluoxetine Sham rTMS/Placebo Fluoxetine
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 2/9 (22.2%) 0/10 (0%) 3/8 (37.5%)
    Nervous system disorders
    Headache 2/9 (22.2%) 3 0/10 (0%) 0 3/8 (37.5%) 6

    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.

    Results Point of Contact

    Name/Title Dr. Felipe Fregni
    Organization Spaulding Rehabilitation Hospital
    Phone 6179526158
    Email fregni.felipe@mgh.harvard.edu
    Responsible Party:
    Felipe Fregni, Principal Investigator, Spaulding Rehabilitation Hospital
    ClinicalTrials.gov Identifier:
    NCT02208466
    Other Study ID Numbers:
    • 2014P001046
    First Posted:
    Aug 5, 2014
    Last Update Posted:
    Feb 21, 2021
    Last Verified:
    Feb 1, 2021