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MyoCI + Memory Reactivation for Stroke Recovery
N/A
Recruiting
Led By Marc W Slutzky, MD/PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age at enrollment is 21 or older
Severe to moderate motor impairment (FMA-UE of 7-40)
Must not have
Visual impairment (such as hemianopia) preventing full view of screen
Substantial arm pain preventing participation for 90 minutes a day
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline at 6 weeks
Summary
This trial will study the effects of a myoelectric computer interface training combined with targeted memory reactivation during sleep in people who have had a stroke.
Who is the study for?
This trial is for chronic stroke survivors aged 21 or older with severe to moderate arm motor impairment, who had their first stroke at least 6 months ago. Participants must have some voluntary shoulder and elbow movement but can't join if they have ferromagnetic implants, are in other studies, struggle with English due to aphasia, suffer from substantial pain or visual impairments that affect screen viewing, or have received spasticity treatment recently.
What is being tested?
The study tests whether combining myoelectric computer interface (MyoCI) training with targeted memory reactivation (TMR) during sleep can improve arm function in people who've had a stroke. It looks at the effects of this combination over an extended period.
What are the potential side effects?
The description does not specify side effects; however, typical risks may include discomfort from wearing the MyoCI device or fatigue from the exercises. TMR involves audio cues during sleep which should be minimally invasive.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
I have severe to moderate difficulty moving my arms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a visual impairment that prevents me from seeing the entire screen.
Select...
I have severe arm pain that stops me from participating in activities for 90 minutes a day.
Select...
I have received spasticity treatment in the last 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline at 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline at 6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Wolf Motor Function Test (WMFT)
Secondary study objectives
Fugl-Meyer Assessment of Upper Extremity (UE) Motor Function
Modified Ashworth Scale
Motor Activity Log (MAL)
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Slow-wave sleep (SWS) only TMRExperimental Treatment1 Intervention
TMR during slow-wave sleep only
Group II: Reduced frequency TMRExperimental Treatment1 Intervention
TMR during only subset of sessions
Group III: All phase TMRExperimental Treatment1 Intervention
TMR during every stage of sleep
Group IV: Sham TMRPlacebo Group1 Intervention
Patients receive no TMR
Find a Location
Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,652 Previous Clinical Trials
961,445 Total Patients Enrolled
34 Trials studying Stroke
25,361 Patients Enrolled for Stroke
Marc W Slutzky, MD/PhDPrincipal InvestigatorNorthwestern University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have anesthesia or neglect in your affected arm, or difficulty paying attention to things on one side of your vision.I have a visual impairment that prevents me from seeing the entire screen.I can move my shoulder and elbow muscles on my own.You have multiple strokes in both sides of your brain.I am 21 years old or older.I have severe to moderate difficulty moving my arms.I have had arm movement issues due to my first stroke 6 months ago.I have severe arm pain that stops me from participating in activities for 90 minutes a day.You are not able to follow the instructions for the MyoCI task.You have metal implants that cannot be used in MRI scans.I have received spasticity treatment in the last 3 months.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 0 awards, including:Research Study Groups:
This trial has the following groups:- Group 1: All phase TMR
- Group 2: Sham TMR
- Group 3: Slow-wave sleep (SWS) only TMR
- Group 4: Reduced frequency TMR