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Recruiting NCT04312269

Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

No phase Interventional Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Targeted Memory Reactivation (TMR).
Who it may be relevant to
Registry conditions: Stroke. Basic parameters: 21 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Targeted Memory Reactivation (TMR)
    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.

Primary outcome measures

  • Wolf Motor Function Test (WMFT) [Time frame: change from baseline at 6 weeks]
Secondary outcome measures (6)
  • Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function [Time frame: change from baseline at 6 weeks]
  • Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function [Time frame: change from baseline at 10 weeks]
  • Motor Activity Log (MAL) [Time frame: change from baseline at 6 weeks]
  • Motor Activity Log (MAL) [Time frame: change from baseline at 10 weeks]
  • Modified Ashworth Scale [Time frame: change from baseline at 6 weeks]
  • Modified Ashworth Scale [Time frame: change from baseline at 10 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Northwestern University — Chicago

Identifiers

NCT: NCT04312269 · SP0052149

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗