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Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

NCT02208466 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-02-21

Study results available
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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

Interventions

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.

DRUG

Fluoxetine

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

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.

DRUG

Placebo Fluoxetine

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

Sponsors & Collaborators

  • Spaulding Rehabilitation Hospital

    lead OTHER

Principal Investigators

  • Felipe Fregni, MD PhD MPH · Spaulding Rehabilitation Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-06-25
Completion
2019-06-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02208466 on ClinicalTrials.gov