Clinical trial NCT02208466: Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients
Official title: Effects of Contralesional Repetitive Magnetic Stimulation Combined With Fluoxetine on Motor Recovery in Acute Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stroke
Motor Function
Keywords: repetitive transcranial magnetic stimulation
rTMS
TMS
fluoxetine
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2014-08-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in Motor Function (Jebsen-Taylor Task)
timeFrame: baseline and 90 days
measure: Changes in Fugl-Meyer Assessment (FMA) Scale
timeFrame: baseline and 90 days
Secondary outcomes:
measure: Changes in Cortical Excitability Measures
timeFrame: Baseline and 90 days
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Felipe Fregni, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.