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Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients

Information source: Spaulding Rehabilitation Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stroke; Motor Function

Intervention: Active Repetitive Transcranial Magnetic Stimulation (rTMS) (Device); Fluoxetine (Drug); Sham repetitive transcranial magnetic stimulation (rTMS) (Device); Placebo Fluoxetine (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Spaulding Rehabilitation Hospital

Official(s) and/or principal investigator(s):
Felipe Fregni, MD PhD MPH, Principal Investigator, Affiliation: Spaulding Rehabilitation Hospital

Overall contact:
Felipe Fregni, MD, PhD, MPH, Phone: 617-952-6156, Email: ffregni@partners.org

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Changes in Motor Function

Secondary outcome: Changes in cortical excitability measures

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Ischemic cerebral infraction within the past 30 days 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 <45 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 or assent with a surrogate

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 implanted medical devices.

- Patients taking any other selective serotonin reuptake inhibitors (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 Spaulding Rehabilitation Hospital (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.

Locations and Contacts

Felipe Fregni, MD, PhD, MPH, Phone: 617-952-6156, Email: ffregni@partners.org

Spaulding Rehabilitation Hospital, Charlestown, Massachusetts 02129, United States; Recruiting
Additional Information

Starting date: September 2014
Last updated: April 7, 2015

Page last updated: August 23, 2015

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