N/A
N=4
Repetitive Transcranial Magnetic Stimulation Use in Acute Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT01922986 ↗Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores — -23.0; 0 percentage of change from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- active rTMS (Device); sham rTMS (Device); conventional stroke therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Jebsen Taylor Hand Function Test Scores |
-23.0; 0 | — |
| SECONDARY Change in Finger Tracking Test |
24.5; -13.8 | — |
| SECONDARY Change in Motricity Index |
4; 11 | — |
Summary
When a certain area of the brain is injured, like in stroke, several events occur. One side of the body may become weak. This weakness is called hemiparesis and it may create difficulty in performing tasks like writing, eating, and walking. The weakness results from two sources:
1. death of some brain cells in the affected side (hemisphere) of the brain
2. exaggerated inhibitory signals from the unaffected hemisphere acting on surviving neurons in the affected hemisphere.
Investigators cannot change neurons that have died but they may be able to change the exaggerated inhibition that impairs the surviving neurons in the affected hemisphere.The purpose of this study is to try to decrease the exaggerated inhibition coming from the unaffected hemisphere, which suppresses the affected hemisphere, with transcranial magnetic stimulation (TMS). Investigators hypothesize that, from admission to discharge, active rTMS combined with conventional therapy will produce greater functional gains in the paretic hand compared to sham rTMS combined with conventional therapy, as measured by standard tests.
Eligibility Criteria
Inclusion Criteria
- stroke onset: within past 30 days but rTMS intervention will commence no sooner than 5 days from stroke onset
- stroke location: cortical or subcortical
- stroke type: ischemic
- age: >18 years
- paretic index finger must show either no or impaired flexion/extension motion at the metacarpophalangeal (MP) joint.
- Mini-Mental State Examination greater than or equal to 22
- ability to stand/transfer with no more than moderate assistance
Exclusion Criteria
- seizure within past two years
- metal in head (dental permitted)
- pregnancy
- psychiatric disorders
- receiving tricyclic antidepressants or neuroleptics
- inability to follow three-step command
- hemineglect
- dependent on ventilator, nasogastric tube, or implanted medical device
- co-morbidities impairing upper extremity function
- anticipated stay at Courage Kenny Rehabilitation Institute shorter than 7 treatment days
Data sourced from ClinicalTrials.gov (NCT01922986). 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.