Motor Priming and Training for Post-Stroke Arm Weakness

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to improve arm strength and function in people who have had a stroke. It tests whether combining motor warm-ups and training can help the brain and body respond better to therapy. Participants will be randomly assigned to one of two groups: one using a gadget that moves both wrists together (Bilateral Motor Priming + Task Specific Training, BMP + TST), or another using gentle electrical stimulation (Control Priming + TST, CP + TST). Those who had a stroke at least six months ago and have trouble with wrist movement might be a good fit. The trial involves several therapy and evaluation visits to determine which method works best.

As an unphased trial, this study offers a unique opportunity to contribute to innovative stroke recovery research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that these motor priming techniques are safe for post-stroke arm weakness?

Research has shown that the treatment combining bilateral motor priming and task-specific training (BMP + TST) is generally easy for patients to handle. Studies have found that bilateral motor priming usually does not cause significant side effects. This method involves using both hands to activate brain activity, preparing the body for more effective therapy.

For the control group using electrical stimulation, previous research suggests that low-intensity electrical stimulation is safe and generally well-accepted. Participants typically do not experience serious side effects with this method.

Both treatments are designed to be safe and to improve arm function after a stroke. The trials aim to harness the body's natural ability to adapt and heal, making these treatments promising options for stroke recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the motor priming and training techniques for post-stroke arm weakness because they take a novel approach to rehabilitation. Unlike standard treatments that often focus on passive exercises or traditional physical therapy, these methods incorporate bilateral motor priming combined with task-specific training. This approach is believed to enhance neural plasticity and engage both sides of the brain, potentially leading to more effective recovery. The use of transcutaneous electric stimulation (TENS) as a control priming adds a unique aspect by subtly activating muscles before task-specific training, which could further improve motor function. By exploring these innovative techniques, researchers hope to uncover more efficient ways to restore arm strength and function after a stroke.

What evidence suggests that this trial's treatments could be effective for post-stroke arm weakness?

This trial will compare two approaches for improving arm function after a stroke. Participants in one group will receive Bilateral Motor Priming combined with Task Specific Training (BMP + TST). Research has shown that using both arms together in specific exercises can improve arm function, reduce arm weakness, and enhance motor skills. Specifically, one study found that training both arms together improved upper limb function, making daily activities easier. This method involves using both hands, with the stronger hand assisting the weaker one in regaining strength. Meanwhile, participants in the other group will receive Control Priming with Task Specific Training (CP + TST), which involves transcutaneous electric stimulation (TENS) followed by the same task-specific training protocol. Overall, these treatments show promise in helping stroke patients regain movement in their affected arms. ^{1 2 3 6 7}

Who Is on the Research Team?

Daniel M Corcos, PhD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

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 a neurological condition like Cerebral Palsy or Parkinson's.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11752083/

Priming and task‐specific training for arm weakness post ...

The objective of this work was to evaluate if task‐specific training (TST) preceded by bilateral upper limb motor priming (BUMP) reduces upper limb impairment ...

2.

ahajournals.org

ahajournals.org/doi/10.1161/str.44.suppl_1.AWMP89

Abstract WMP89: Bilateral Priming Followed by Task ...

Hypothesis: The objective of this pilot study was to test our hypothesis that bilateral priming combined with task specific training (TST) would be effective in ...

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1052305723001544

Effect of task-based bilateral arm training on upper limb ...

Task-based BAT appears to improve upper limb motor function post stroke. The benefits of task-based BAT on activity performance and participation in real life ...

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39688835/

Priming and task-specific training for arm weakness post stroke

The objective of this work was to evaluate if task-specific training (TST) preceded by bilateral upper limb motor priming (BUMP) reduces upper limb impairment.

5.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06465-9

Bilateral upper extremity motor priming (BUMP) plus task ...

The aim of this study is to determine the effects of a 5-week protocol of bilateral motor priming in combination with task-specific training on motor ...

6.

frontiersin.org

frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1182561/full

Combining high dose therapy, bilateral motor priming, and ...

... rehabilitation protocols to produce meaningful improvements in patients with significant arm weakness in the chronic phase post-stroke. Dose ...

7.

researchgate.net

researchgate.net/publication/361478931_Bilateral_upper_extremity_motor_priming_BUMP_plus_task-specific_training_for_severe_chronic_upper_limb_hemiparesis_study_protocol_for_a_randomized_clinical_trial

Bilateral upper extremity motor priming (BUMP) plus task ...

Priming and task‐specific training for arm weakness post stroke: A randomized controlled trial. December 2024 · Annals of Clinical and Translational Neurology.