Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients
Effects of Contralesional Repetitive Magnetic Stimulation Combined With Fluoxetine on Motor Recovery in Acute Stroke Patients
1 other identifier
interventional
44
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 stroke
Started Sep 2014
Longer than P75 for phase_2 stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedStudy Start
First participant enrolled
September 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 25, 2019
CompletedResults Posted
Study results publicly available
February 21, 2021
CompletedFebruary 21, 2021
February 1, 2021
4.8 years
July 28, 2014
November 25, 2020
February 2, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in Motor Function (Jebsen-Taylor Task)
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
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 Outcomes (1)
Changes in Cortical Excitability Measures
Baseline and 90 days
Study Arms (3)
Active rTMS/active fluoxetine
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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
EXPERIMENTALSubjects 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.
Interventions
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.
Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
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.
Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spaulding Rehabilitation Hospital
Charlestown, Massachusetts, 02129, United States
Related Publications (1)
Bonin Pinto C, Morales-Quezada L, de Toledo Piza PV, Zeng D, Saleh Velez FG, Ferreira IS, Lucena PH, Duarte D, Lopes F, El-Hagrassy MM, Rizzo LV, Camargo EC, Lin DJ, Mazwi N, Wang QM, Black-Schaffer R, Fregni F. Combining Fluoxetine and rTMS in Poststroke Motor Recovery: A Placebo-Controlled Double-Blind Randomized Phase 2 Clinical Trial. Neurorehabil Neural Repair. 2019 Aug;33(8):643-655. doi: 10.1177/1545968319860483. Epub 2019 Jul 9.
PMID: 31286828DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Felipe Fregni
- Organization
- Spaulding Rehabilitation Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Felipe Fregni, MD PhD MPH
Spaulding Rehabilitation Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 28, 2014
First Posted
August 5, 2014
Study Start
September 1, 2014
Primary Completion
June 25, 2019
Study Completion
June 25, 2019
Last Updated
February 21, 2021
Results First Posted
February 21, 2021
Record last verified: 2021-02