Status:
COMPLETED
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity
Lead Sponsor:
University of Minnesota
Conditions:
Spasticity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Spasticity is a common complication of stroke affecting quality of life. Spasticity involves exaggerated stretch reflexes that create stiffness in muscles with associated loss of motion and functional...
Detailed Description
The purpose of this pilot study is to evaluate the efficacy of rTMS versus placebo for spasticity reduction in a cross-over design in 6 people with stroke. Our research question is: In patients with ...
Eligibility Criteria
Inclusion
- first-time stroke
- stroke at least six months prior to onset of study with chronic sequela of spasticity
- stroke location- either cortical or subcortical
- stroke type- either hemorrhagic or ischemic
- stroke hemisphere- either left or right, dominant or non- dominant hemisphere
- 18 years of age or older
- gender- either male or female
- ability to follow three-step directions
- demonstration of 10 degrees of active extension at the metacarpophalangeal joint and wrist of the paretic upper extremity
- demonstration of consistent resting motor evoked potential from ipsilesional and contralesional hemispheres
- sufficient ambulation or wheelchair mobility to allow subject to present to treatment and testing areas with minimum assist
Exclusion
- history of seizure within the past two years
- inability to follow three-step directions
- anosognosia
- moderate to severe receptive aphasia
- inability to give informed consent
- premorbid spasticity or neurologic impairment prior to stroke
- co-morbidities impairing upper extremity function such as fracture or deformity
- indwelling metal or medical devices incompatible with TMS
- pregnancy
- bi-hemispheric or multifocal stroke
- dementia
- neurolytic injection within the 3 months prior to onset of study or planned neurolytic injection during study period
- planned vacation or travel during study period
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02268461
Start Date
December 1 2014
End Date
December 1 2016
Last Update
January 27 2025
Active Locations (1)
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1
University of Minnesota, Clinical and Translational Science Institute
Minneapolis, Minnesota, United States, 55414