Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

February 2, 2021 updated by: Felipe Fregni, Spaulding Rehabilitation Hospital

Effects of Contralesional Repetitive Magnetic Stimulation Combined With Fluoxetine on Motor Recovery in Acute Stroke Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Charlestown, Massachusetts, United States, 02129
        • Spaulding Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Motor Function (Jebsen-Taylor Task)
Time Frame: 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).
baseline and 90 days
Changes in Fugl-Meyer Assessment (FMA) Scale
Time Frame: 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).
baseline and 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Cortical Excitability Measures
Time Frame: 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).
Baseline and 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spaulding Rehabilitation Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (ACTUAL)

June 25, 2019

Study Completion (ACTUAL)

June 25, 2019

Study Registration Dates

First Submitted

July 28, 2014

First Submitted That Met QC Criteria

August 1, 2014

First Posted (ESTIMATE)

August 5, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 2, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P001046

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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