# NCT04312269: Combining MyoCI With Memory Reactivation to Improve Motor Recovery After Stroke

Registry record: https://clinicaltrials.gov/study/NCT04312269 (retrieved 2026-09-30). Sponsor: Northwestern University.

## What you are forecasting

**Primary hypothesis (implied by design):** Myoelectric computer interface training combined with targeted memory reactivation (TMR) during sleep improves arm function (Wolf Motor Function Test) more than the same training with sham TMR after 6 weeks in chronic stroke survivors.

**Resolution rule:** Supported if the all-phase TMR arm, or the TMR arms pooled if that is the reported primary contrast, shows significantly greater WMFT improvement from baseline to 6 weeks than sham TMR.

**Alpha:** 0.05, two-sided, unless the report states otherwise

**Effect metric for your 90% interval:** Between-group difference in WMFT change (time-based score, as reported), expressed as Cohen's d (positive = more improvement with TMR).

**Moderator to consider:** Does TMR confined to slow-wave sleep work as well as TMR in all sleep stages?

## Design

- Allocation: RANDOMIZED; model: PARALLEL; purpose: TREATMENT
- Masking: DOUBLE ['PARTICIPANT', 'OUTCOMES_ASSESSOR']
- Enrollment: 70 (estimated)
- Phase: NA
- Status on registry: RECRUITING; start 2020-02-25; primary completion 2027-01-30 (estimated)

## Arms

- **All phase TMR** (experimental): TMR during every stage of sleep
- **Slow-wave sleep (SWS) only TMR** (experimental): TMR during slow-wave sleep only
- **Reduced frequency TMR** (experimental): TMR during only subset of sessions
- **Sham TMR** (sham comparator): Patients receive no TMR

## Primary outcome(s) as registered

- **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 outcomes (names only)

- Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function (change from baseline at 6 weeks)
- Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function (change from baseline at 10 weeks)
- Motor Activity Log (MAL) (change from baseline at 6 weeks)
- Motor Activity Log (MAL) (change from baseline at 10 weeks)
- Modified Ashworth Scale (change from baseline at 6 weeks)
- Modified Ashworth Scale (change from baseline at 10 weeks)

## Population

Ages 21 Years to 100 Years; sex: ALL; healthy volunteers: False.

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

## Registry 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.