Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

Phase 2

Completed

• Conditions: Stroke; Motor Function
• Interventions: Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS); Device: Sham repetitive transcranial magnetic stimulation (rTMS); Drug: Placebo Fluoxetine; Drug: Fluoxetine

• Registration Number: NCT02208466
• Lead Sponsor: Spaulding Rehabilitation Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-28
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Study Start: 2014-09
• Primary Completion: 2019-06-25
• Study Completion: 2019-06-25
• Results First Submitted: 2020-11-25
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-02
• Last Update Submitted: 2021-02-02
• Results First Posted: 2021-02-21
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active rTMS/active fluoxetine	Active Repetitive Transcranial Magnetic Stimulation (rTMS)	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.
Sham rTMS/active fluoxetine	Sham repetitive transcranial magnetic stimulation (rTMS)	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.
Sham rTMS/placebo fluoxetine	Sham repetitive transcranial magnetic stimulation (rTMS)	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 rTMS/placebo fluoxetine	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.
Active rTMS/active fluoxetine	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.
Sham rTMS/active fluoxetine	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.

Primary Outcome Measures

Name	Time	Method
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).
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

Name	Time	Method
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).

Trial Locations

Locations (1)

Spaulding Rehabilitation Hospital; 🇺🇸 Charlestown, Massachusetts, United States