Electrical Stimulation + Occupational Therapy for Stroke Recovery

No longer recruiting at 3 trial locations

Overseen By Amanda Khoudary

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Botulinum toxin

Disqualifiers: Peripheral nerve injury, Parkinson's, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to help people regain hand movement after a stroke. It compares three treatments: electrical stimulation (a device that sends small electrical impulses to help open the weak hand), practicing daily tasks with the weak hand through occupational therapy, and a special type of electrical stimulation that works with the non-affected hand. Participants should have experienced their first stroke between 6 to 24 months ago and have difficulty using one arm due to the stroke. The goal is to determine which method best improves hand function. As an unphased trial, this study allows participants to explore innovative recovery methods and contribute to advancing stroke rehabilitation techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you cannot receive occupational therapy while participating.

What prior data suggests that these therapies are safe for stroke recovery?

Research has shown that both Cyclic Neuromuscular Electrical Stimulation (cNMES) and Contralaterally Controlled Functional Electrical Stimulation (CCFES) are generally well-tolerated by patients recovering from a stroke.

For cNMES, studies have found it improves arm and hand function after a stroke. While some research also examines its use for leg recovery, electrical stimulation in therapy is generally considered helpful. No significant reports of serious side effects indicate it is safe.

CCFES, a new method aimed at improving hand movement after a stroke, has been shown to enhance movement in affected limbs. Current studies do not report major side effects, suggesting it is a safe option for stroke recovery.

Both treatments use electrical stimulation, which has been widely studied and used in various rehabilitation therapies, indicating a good safety record for both cNMES and CCFES. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for stroke recovery because they explore innovative ways to improve hand function. Unlike standard rehabilitation methods that rely solely on physical exercises, Cyclic Neuromuscular Electrical Stimulation (cNMES) automatically stimulates hand opening through electrical impulses, making repetitive motion less dependent on patient effort. Task Oriented Therapy (TOT) emphasizes repetitive practice of daily tasks with the affected hand, aiming for high-dose task engagement. Contralaterally Controlled Functional Electrical Stimulation (CCFES) introduces a unique twist by using the movement of the unaffected hand to trigger stimulation in the affected hand, creating a mirror effect that may enhance neural connections. This trial seeks to determine if these methods can offer quicker, more effective recovery for stroke survivors compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for stroke recovery?

This trial will compare different therapies for stroke recovery. Studies have shown that cyclic neuromuscular electrical stimulation (cNMES), one of the therapies in this trial, helps stroke patients regain movement, particularly in the affected arm, and improves the ability to perform everyday tasks. Another therapy being tested, contralaterally controlled functional electrical stimulation (CCFES), has proven even more effective than traditional NMES, enhancing arm function. Task-oriented therapy (TOT), also included in this trial, involves practicing real-life activities and aids recovery by improving daily activities and overall quality of life for stroke survivors. Each of these therapies has demonstrated promise in helping hands recover after a stroke. ^{1 2 6 7 8}

Who Is on the Research Team?

Jayme Knutson, PhD

Principal Investigator

MetroHealth Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who've had their first stroke 6-24 months ago, leading to hand weakness but can still open their other hand fully. They should be able to follow instructions and have no severe pain when using a finger stimulator. Excluded are those with other neurological issues, uncontrolled seizures, certain heart conditions, pregnancy, or visual/hearing impairments that would affect participation.

Inclusion Criteria

The skin on my weaker arm is not broken or damaged.

I had a stroke between 6 and 24 months ago.

You can hear and respond to signals from the device.

Exclusion Criteria

Deficits in communication that interfere with reasonable study participation

I have a condition that significantly impacts the function of my affected arm and hand, not caused by a stroke.

I have severe pain in my shoulder or hand.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 12 weeks of therapy using CCFES, cNMES, or Task Oriented Training, with 10 self-administered sessions per week at home and 2 occupational therapy sessions per week in the lab

12 weeks

2 visits per week (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 12 and 36 weeks

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electrical Stimulator
• Occupational Therapy

Trial Overview The study compares three therapies aimed at improving hand function after a stroke: an electrical stimulator designed to help move fingers and thumb; occupational therapy; and possibly a combination of both. It seeks to find out which method might be most effective in aiding recovery.

How Is the Trial Designed?

Group I: CCFES Experimental Treatment 2 Interventions

Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses an electrical stimulator and surface electrodes placed over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. Thus, volitional opening of the nonparetic hand produces stimulated opening of the paretic hand. During the lab visits, participants in the CCFES group will use CCFES to assist hand opening during occupational therapy task practice. During their home sessions, participants in the CCFES group will use CCFES to perform hand opening exercise.

Group II: cNMES Active Control 2 Interventions

Cyclic Neuromuscular Electrical Stimulation (cNMES) uses an electrical stimulator and surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation to open the weak hand. The stimulation automatically turns on and off causing the weak hand to open repetitively for several seconds at a time. During the lab visits, participants in the cNMES group will receive occupational therapy task practice. During their home sessions, participants in the cNMES group will use cNMES to perform hand opening exercise.

Group III: Task Oriented Therapy Active Control 1 Intervention

Task Oriented Therapy (TOT) focuses on practicing using the weak hand to practice activities of daily living tasks. During the clinic visits, participants in the TOT group will receive occupational therapy task practice. During their home sessions, participants in the TOT group will practice using their hand to complete a list of tasks given to them by the therapist to ensure that the participant receives a high dose of task practice.

Occupational Therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Approved in European Union as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Approved in Canada as Occupational Therapy for:

• Rehabilitation
• Physical disabilities
• Mental health conditions
• Cancer-related fatigue

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Kessler Foundation

Collaborator

Trials

190

Recruited

11,300+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10915254/

The efficacy of contralaterally controlled functional electrical ... The results of this study provide strong evidence that shows CCFES being a better electrical stimulation modality compared to conventional NMES.

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.1010975/full

Effectiveness of contralaterally controlled functional ... The aim of this study is to compare the efficacy of CCFES vs. NMES for recovery of the lower extremity in 6 months post-stroke by lower limb functional ...

3. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06303-y

Efficacy of contralaterally controlled functional electrical ... This study will determine whether CCFES therapy produces greater improvements in upper extremity function than cNMES or TOT.

4. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.116.013791

Contralaterally Controlled Functional Electrical Stimulation ... The goal of this study was to compare the efficacy of CCFES to cNMES on upper limb impairment and function in patients who are >6 months post ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3561720/

Contralaterally Controlled Functional Electrical Stimulation for ... It is being studied to evaluate its efficacy in improving recovery of arm and hand function and ankle dorsiflexion in chronic and subacute stroke patients. The ...

6. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.869733/full

Contralaterally Controlled Functional Electrical Stimulation ... Background: Approximately two-thirds of stroke survivors experience chronic upper limb paresis, and of them, 50% experience severe paresis.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03870672

rTMS Plus CCFES-mediated Functional Task Practice for ... This study is a necessary and important step in the development of a new therapy for upper limb functional recovery in patients with severe motor impairment ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9117963/

Contralaterally Controlled Functional Electrical Stimulation ... Approximately two-thirds of stroke survivors experience chronic upper limb paresis, and of them, 50% experience severe paresis.