N/A
N=4
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment of Post-Stroke Spasticity
Spasticity
Bottom Line
View on ClinicalTrials.gov: NCT02268461 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Change From Baseline Contralesional Corticospinal Excitability — 67.88; -37.23 microVolts
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- repetitive Transcranial Magnetic Stimulation (rTMS) (Device); Sham repetitive Transcranial Magnetic Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Contralesional Corticospinal Excitability |
67.88; -37.23 | — |
| PRIMARY Change From Baseline Finger Tracking Score |
11.95; 8.01 | — |
| SECONDARY Change in Stroke Impact Scale |
-0.25; -0.5 | — |
| SECONDARY Change From Baseline Resting Motor Threshold |
-2.25; -3.75 | — |
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 control. Traditional treatments involve range of motion, medications, and sometimes surgery. Each of these has its own limitations, which has invited exploration of alternative modes of treatment. One such treatment with the potential to benefit spasticity is repetitive Transcranial Magnetic Stimulation (rTMS).
The purpose of this study is to determine whether patients with upper limb spasticity as a consequence of a chronic stroke can benefit from stimulation of the non-affected hemisphere of the brain with low-frequency (inhibitory) repetitive Transcranial Magnetic Stimulation (rTMS), potentially leading to a reduction of spasticity and clinical improvement in upper limb function.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02268461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.