N/A
N=10
Modulating Interaction of Motor Learning Networks in Rehabilitation of Stroke
Stroke · Stroke, Chronic · Stroke, Middle Cerebral Artery With Infarction
Bottom Line
View on ClinicalTrials.gov: NCT03086551 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Change From Baseline in Sequential Response Time to Post-Intervention — 8.68; 8.84; 8.32; 7.96 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active continuous theta burst stimulation (cTBS) (Device); Placebo (Sham) continuous theta burst stimulation (Device); Motor Practice (Behavioral)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Sequential Response Time to Post-Intervention |
8.68; 8.84; 8.32; 7.96; 0.37; 0.88 | — |
| SECONDARY Change From Baseline in Time to Complete the Jebsen-Taylor Hand Function Test |
95.68; 86.07; 100.05; 76.27; -4.38; 9.80 | — |
| SECONDARY Change in Sequential Response Time Immediately Follow an Individual Bout of Non-invasive Brain Stimulation (e.g. Within Session) |
0.41; 0.89; 0.72; 0.80; -0.20; 0.22 | — |
| SECONDARY Motor Evoked Potential Amplitude (in Microvolts) at Pre-baseline and Post-Intervention |
1558; 971; 1216; 511; 2750; 1977 | — |
| SECONDARY Change From Baseline in Cortical Excitability Post-Intervention |
-26; -19; -17; 25 | — |
Summary
This study uses a form on non-invasive brain stimulation called transcranial magnetic stimulation to understand 1) understand how the brain learns post-stroke and 2) assess non-invasive brain stimulation as an addition to current stroke rehabilitation approaches. In two study arms the investigators will compare the effect of active transcranial magnetic stimulation paired with motor practice with placebo (or sham) transcranial magnetic stimulation paired with the same motor practice.
Eligibility Criteria
Inclusion Criteria
- Age between 50-75 years
- movement-related deficit associated with first time middle cerebral artery stroke
- greater than 6-months post-stroke
- Fugl-Meyer score between 15 and 60
- ability to elicit a motor evoked potential from the ipsilesional cortex
Exclusion Criteria
- a score <27 on the Mini-Mental Status Exam
- a score of <123 on the Mattis Dementia Rating Scale
- a score of <13 on the Frenchay Aphasia Screen
- a history of seizure/epilepsy, head trauma, major psychiatric diagnosis, neurodegenerative disorder or substance abuse
- a history of congestive heart failure
- systolic blood pressure above 120 mmHg and/or diastolic pressure above 80 mmHg
- the taking of any GABAergic, NMDA-receptor antagonist or other drug known to influence the neural receptors that facilitate neural plasticity
- an infarct resulting from ischemic stroke of anterior or posterior cerebral artery OR an infarct that encroaches within 2cm of the site of cTBS stimulation
- absence of an MEP in response to single pulse transcranial magnetic stimulation over ipsilesional M1 and 10) any other contraindication to TMS or MRI.
Data sourced from ClinicalTrials.gov (NCT03086551). 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.