Motor Priming and Training for Post-Stroke Arm Weakness

Recruiting at 1 trial location

Overseen By Alexandra Wax, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Seizures, Epilepsy, Pacemaker, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 5-6 weeks

80 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing two methods to help stroke survivors improve arm function: using both hands together with a tool or using gentle electrical signals. The study focuses on people with severe arm weakness after a stroke. The goal is to see which method better prepares the brain for therapy and leads to greater improvements in arm movement. Electrical stimulation therapy can effectively improve the arm function in stroke patients.

Research Team

Daniel M Corcos, PhD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for stroke survivors with severe arm weakness (hemiparesis) who had a stroke at least 6 months ago, without cerebellum involvement. They should have some wrist movement and score within a specific range on the FMUE TEST. Excluded are those with hearing issues, persistent headaches, certain orthopedic conditions, low cognitive scores, metal in head/neck area, seizure history, concussion with loss of consciousness, pacemakers/neurostimulators, pregnancy or metastatic cancer.

Inclusion Criteria

I had a stroke that did not affect my cerebellum at least 6 months ago.

I had a stroke that did not affect my cerebellum over 6 months ago.

My wrist stiffness is mild to moderate.

Exclusion Criteria

You have had a concussion that caused you to lose consciousness.

You have ringing in your ears or have cochlear implants.

I have had ongoing headaches.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either bilateral motor priming plus task specific training or control priming plus task specific training for 30 hours over 5 weeks

5-6 weeks

15 therapy visits, 9 evaluation visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations occurring 8 weeks post-treatment

8 weeks

3 follow-up evaluation visits

Treatment Details

Interventions

• Bilateral Motor Priming + Task Specific Training (BMP + TST)
• Control Priming + TST (CP + TST)

Trial Overview The study tests two treatments to improve arm function after stroke: one uses bilateral motor priming (BMP), where both wrists move together using a device; the other uses electrical stimulation priming (CP). Both groups receive task-specific training (TST). Participants will be randomly assigned to either group and undergo evaluations before treatment starts, after it ends and at an 8-week follow-up.

Participant Groups

Group I: Bilateral motor priming + Task specific training (BMP + TST) Experimental Treatment 1 Intervention

A combination of bilateral motor priming (BMP) plus task specific training (TST) for 30 hours over 5 weeks.

Group II: Control Priming + TST (CP + TST) Active Control 1 Intervention

The control priming is transcutaneous electric stimulation (TENS) set at a low threshold followed by the same task specific training protocol for 30 hours over 5 weeks.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Shirley Ryan AbilityLab

Collaborator

Trials

212

Recruited

17,900+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+