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NCT Number: NCT04312269

Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Memory Reactivation (TMR)

Other

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 outcomes

  1. Wolf Motor Function Test (WMFT)

    Time frame: 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 outcomes

  1. Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function

    Time frame: 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.

  2. Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function

    Time frame: change from baseline at 10 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.

  3. Motor Activity Log (MAL)

    Time frame: 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.

  4. Motor Activity Log (MAL)

    Time frame: change from baseline at 10 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.

  5. Modified Ashworth Scale

    Time frame: 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.

  6. Modified Ashworth Scale

    Time frame: change from baseline at 10 weeks

    The Modified Ashworth Scale is a measure of spasticity, which is graded on a scale of 0-4 per joint tested.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Mar 18, 2020
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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