Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

NCT ID: NCT02208466

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2019-06-25

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.

Conditions

Stroke; Motor Function

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Active Repetitive Transcranial Magnetic Stimulation (rTMS)

Intervention Type: DEVICE

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

Intervention Type: DRUG

Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.

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.

Group Type: EXPERIMENTAL

Fluoxetine

Intervention Type: DRUG

Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.

Sham repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

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.

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.

Group Type: EXPERIMENTAL

Sham repetitive transcranial magnetic stimulation (rTMS)

Intervention Type: DEVICE

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

Intervention Type: DRUG

Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.

Interventions

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.

Intervention Type: DEVICE

Fluoxetine

Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.

Intervention Type: DRUG

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.

Intervention Type: DEVICE

Placebo Fluoxetine

Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.

Intervention Type: DRUG

Other Intervention Names

magnetic stimulation, Magstim; Prozac, Sarafem, Ladose, Fontex; Magstim, magnetic stimulation; Prozac, Sarafem, Ladose, Fontex

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spaulding Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Fregni

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Felipe Fregni, MD PhD MPH

Role: PRINCIPAL_INVESTIGATOR

Spaulding Rehabilitation Hospital

Locations

Spaulding Rehabilitation Hospital

Charlestown, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 31286828 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2014P001046

Identifier Type: -

Identifier Source: org_study_id