What is the mechanism of action of this treatment?

Bilateral Motor Priming involves using both hands to facilitate movement in the affected arm, leveraging the concept of inter-limb coupling where the movement of the unaffected limb helps stimulate and improve motor function in the affected limb. This method aims to enhance neural plasticity and promote motor recovery by engaging both hemispheres of the brain. Electrical Stimulation Priming uses low-intensity electrical stimulation to enhance motor function by increasing cortical excitability and promoting neural reorganization in the affected areas. These treatments are crucial for stroke patients as they target the underlying neural mechanisms to improve motor function, reduce disability, and enhance the overall quality of life.

What side effects are associated with this type of intervention?

Bilateral Motor Priming, which involves using both hands to facilitate movement in the affected arm, generally has minimal side effects but may include muscle soreness or fatigue from repetitive movements. Electrical Stimulation Priming, which uses low-intensity electrical stimulation to enhance motor function, can cause mild discomfort, skin irritation, or tingling sensations at the site of stimulation. Both treatments are generally well-tolerated with no serious adverse events reported.

What prior FDA approvals exist?

The FDA has approved several treatments aimed at improving motor function in stroke patients, though specific approvals for bilateral motor priming and low-intensity electrical stimulation are not explicitly mentioned. Generally, treatments like Transcranial Magnetic Stimulation (TMS) and various forms of neuromodulation have been explored and approved for enhancing motor recovery post-stroke. These treatments aim to stimulate brain activity and improve motor function, aligning with the principles of electrical stimulation priming being studied in the trial.

What other types of research exist?

Promising novel alternatives for stroke rehabilitation in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which uses magnetic fields to stimulate nerve cells in the brain to improve motor function. 2) Transcutaneous Electrical Nerve Stimulation (TENS), which involves applying low-voltage electrical currents through the skin to stimulate nerves and enhance motor recovery. 3) Virtual Reality (VR) Therapy, which provides immersive environments to engage patients in motor training exercises, enhancing motivation and neuroplasticity. 4) Robot-Assisted Therapy, which uses robotic devices to assist and guide limb movements, providing precise and repetitive training. These alternatives offer non-invasive, engaging, and potentially more effective options for stroke rehabilitation.

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Motor Priming and Training for Post-Stroke Arm Weakness

N/A

Waitlist Available

Led By Daniel M Corcos, PhD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

0-3 wrist flexion/wrist extension on Modified Ashworth Scale

Be older than 18 years old

Must not have

History of persistent headaches

Other neurological conditions (as in Cerebral Palsy or Parkinson's)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change in baseline fugl myer score at follow-up (8 weeks after treatment ends)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly mentioned in the provided information about this clinical trial's interventions – BMP + TST or CP + TST – potential side effects may include discomfort from wearing devices or fatigue due to exercise. The use of Transcranial Magnetic Stimulation for assessment could potentially cause mild headache or scalp sensations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My wrist stiffness is mild to moderate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had ongoing headaches.

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I have a neurological condition like Cerebral Palsy or Parkinson's.

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I have metal implants or fragments in my head or neck.

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My cancer has spread to other parts of my body.

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I have a history of seizures, epilepsy, or convulsions.

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I have a condition in my less affected or affected wrist.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change in baseline fugl myer score at follow-up (8 weeks after treatment ends)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change in baseline fugl myer score at follow-up (8 weeks after treatment ends)

This trial's timeline: 3 weeks for screening, Varies for treatment, and change in baseline fugl myer score at follow-up (8 weeks after treatment ends) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fugl Myer Test of Upper Extremity Function

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bilateral motor priming + Task specific training (BMP + TST)Experimental Treatment1 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 Control1 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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bilateral Motor Priming involves using both hands to facilitate movement in the affected arm, leveraging the concept of inter-limb coupling where the movement of the unaffected limb helps stimulate and improve motor function in the affected limb. This method aims to enhance neural plasticity and promote motor recovery by engaging both hemispheres of the brain. Electrical Stimulation Priming uses low-intensity electrical stimulation to enhance motor function by increasing cortical excitability and promoting neural reorganization in the affected areas. These treatments are crucial for stroke patients as they target the underlying neural mechanisms to improve motor function, reduce disability, and enhance the overall quality of life.

The potential for utilizing inter-limb coupling in the rehabilitation of upper limb motor disability due to unilateral brain injury.