Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

Mass General Brigham

Status and phase

Completed

Phase 2

Conditions

Stroke

Motor Function

Treatments

Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)

Drug: Fluoxetine

Device: Sham repetitive transcranial magnetic stimulation (rTMS)

Drug: Placebo Fluoxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT02208466

2014P001046

Details and patient eligibility

About

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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

44 participants in 3 patient groups

Active rTMS/active fluoxetine

Experimental 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.

Treatment:

Drug: Fluoxetine

Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)

Sham rTMS/active fluoxetine

Experimental group

Description:

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.

Treatment:

Device: Sham repetitive transcranial magnetic stimulation (rTMS)

Drug: Fluoxetine

Sham rTMS/placebo fluoxetine

Experimental group

Description:

Treatment:

Drug: Placebo Fluoxetine

Device: Sham repetitive transcranial magnetic stimulation (rTMS)

Trial documents