Stroke
Conditions
Keywords
Sleep
Brief summary
This study will examine the combination of myoelectric computer interface (MyoCI) training with targeted memory reactivation (TMR) in chronic stroke survivors. The study aims to determine whether this training-plus-sleep combination will generalize to improve arm motor function over an extended training protocol in stroke survivors.
Interventions
Targeted memory reactivation (TMR) refers to the process of playing audio cues associated with specific learned material quietly during sleep in order to strengthen consolidation of specific memories during sleep.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcomes assessors and participant are blinded to groups.
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age at enrollment is 21 or older * Hemiparesis from first ever stroke affecting arm movement at least 6 months prior to screening * Severe to moderate motor impairment (FMA-UE of 7-40) * At least some voluntary shoulder and elbow muscle activation
Exclusion criteria
* Inability to follow instructions of the MyoCI task * Visual impairment (such as hemianopia) preventing full view of screen * Anesthesia or neglect in the affected arm, or visual hemineglect (score of 2 on the NIH Stroke Scale Extinction and Inattention subtest) * Participation in another study on the affected arm within 6 weeks of enrollment or any pharmacological study * Inability to understand or follow commands in English due to aphasia or other reason * Diffuse or multifocal infarcts in both hemispheres * Substantial arm pain preventing participation for 90 minutes a day * Spasticity treatment (pharmacological or Botox) within last 3 months * Ferromagnetic implants that are MRI incompatible
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wolf Motor Function Test (WMFT) | change from baseline at 6 weeks | The WMFT evaluates upper extremity function on a continuous scale. It measures the time it takes to perform 15 different tasks, with a time limit of 120 s per task. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function | change from baseline at 6 weeks | The FMA-UE is a measure of impairment. Maximum score is 66 on the motor function portion. Items are scored on a 3-point ordinal scale. |
| Motor Activity Log (MAL) | change from baseline at 6 weeks | The MAL is a validated measure of home-based arm function, both quantity and quality of use in 30 different activities of daily living. |
| Modified Ashworth Scale | change from baseline at 6 weeks | The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested. |
Countries
United States
Contacts
CONTACTMarc W Slutzky, MD/PhD
PRINCIPAL_INVESTIGATORMarc W Slutzky, MD/PhD
Northwestern University
Outcome results
None listed