Prism Adaptation Therapy + Electrical Stimulation for Stroke Rehabilitation

Recruiting at 2 trial locations

Overseen By Fisayo Aloba, PT, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Must not be taking: Cortical excitability medications

Disqualifiers: Neurological disorders, Uncontrolled hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

35 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to understand how prism adaptation training with and without electrical stimulation changes visuospatial behavior, motor system neurophysiology, and walking dysfunction.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that increase brain activity, you may not be eligible to participate.

What data supports the effectiveness of the treatment Prism Adaptation Therapy + Electrical Stimulation for Stroke Rehabilitation?

Research shows that neuromuscular electrical stimulation (NMES) can aid in motor recovery for stroke patients, and transcutaneous electrical nerve stimulation (TENS) has been effective in improving motor function in children with cerebral palsy. Additionally, combining electrical stimulation with physical training has shown benefits in improving motor functions in patients with brain injuries. ^{1 2 3 4 5}

Is Prism Adaptation Therapy combined with Electrical Stimulation safe for humans?

Research suggests that electrical stimulation, including Neuromuscular Electrical Stimulation (NMES) and Functional Electrical Stimulation (FES), is generally safe and well-tolerated in humans, with rare reports of direct adverse reactions. ^{1 6 7 8 9}

How is Prism Adaptation Therapy combined with Electrical Stimulation unique for stroke rehabilitation?

This treatment is unique because it combines Prism Adaptation Therapy (PAT), which helps retrain the brain to adjust to visual and spatial changes, with Electrical Stimulation (E-stim), which uses electrical impulses to stimulate muscle movement and improve motor function. This combination aims to enhance recovery by addressing both visual-spatial neglect and motor impairments in stroke patients. ^{1 10 11 12 13}

Research Team

Trisha Kesar, PT, PhD

Principal Investigator

Emory University

Fisayo Aloba, PT, DPT

Principal Investigator

Emory University

Eligibility Criteria

This trial is for healthy young adults (18-30 years), older adults (45-90 years) without disabilities, and individuals aged 40-90 who've had a right hemisphere stroke over 3 months ago. Stroke survivors must have spatial neglect, be able to walk more than 10m, and have certain arm strength. Exclusions include other neurological disorders, severe medical conditions, pregnancy, uncontrolled hypertension, or skin issues where devices attach.

Inclusion Criteria

I am between 18-30 years old and do not have any physical disabilities or neurological disorders.

I am between 45-90 years old, healthy, and do not have any physical disabilities or neurological disorders.

I had a stroke in the right side of my brain, can walk more than 10m, and have weak left arm strength.

Exclusion Criteria

I am a young or older adult with a physical condition but no major health issues like uncontrolled high blood pressure, pacemakers, or skin conditions that would interfere with electrical stimulation.

I had a stroke on the right side of my brain, am between 40-90 years old, and don't have any listed health issues that would exclude me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo prism adaptation training with or without electrical stimulation to study effects on visuospatial behavior and motor cortical excitability

6-8 weeks

Weekly sessions

Follow-up

Participants are monitored for changes in spatial neglect deficits, corticospinal excitability, and walking function

4 weeks

Treatment Details

Interventions

• Electrical stimulation (E-stim)
• Gait Training
• Prism adaptation therapy (PAT)
• Prism adaptation therapy (PAT) + Sham Stimulator

Trial Overview The study tests how prism adaptation therapy (PAT), with or without electrical stimulation (E-stim), affects visuospatial behavior and walking in people after a stroke. It also looks at changes in the motor system's neurophysiology. Participants will receive PAT combined with either real or sham E-stim alongside gait training.

Participant Groups

Group I: Stroke with Spatial Neglect (SN) individuals Experimental Treatment 3 Interventions

40-90 years individuals with more than 3 months following right hemisphere stroke.

Group II: Old Able-Bodied individuals Active Control 2 Interventions

45-90 years old able-bodied individuals (healthy without any physical disability or neurological disorder).

Group III: Young Able-Bodied individuals Active Control 2 Interventions

18-30 years old able-bodied individuals (healthy without any physical disability or neurological disorder).

Electrical stimulation (E-stim) is already approved in United States, European Union for the following indications:

Approved in United States as Electrical Stimulation for:

• Stroke rehabilitation
• Muscle strengthening
• Pain management
• Spasticity reduction

Approved in European Union as Electrical Stimulation for:

• Stroke rehabilitation
• Upper limb recovery
• Muscle strengthening
• Spasticity reduction

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Findings from Research

In a study involving 43 patients with chronic stroke, the hybrid treatment combining neuromuscular electrical stimulation (NMES) and noxious thermal stimulation (NTS) showed significant improvements in upper extremity recovery, as measured by the Fugl-Meyer assessment, compared to baseline.

However, the hybrid approach did not demonstrate superior efficacy over NMES or NTS alone, suggesting that while it is beneficial, it may not provide additional advantages beyond the individual treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of the hybrid of neuromuscular electrical stimulation and noxious thermal stimulation on upper extremity motor recovery in patients with stroke: a randomized controlled trial. Chen, CC., Tang, YC., Hsu, MJ., et al.[2019]

Individuals with stroke expressed a positive attitude towards using technology and exergames for rehabilitation, believing that these tools could enhance their functional recovery despite having limited prior experience with them.

Participants identified key factors for successful adoption of exergames, including the need for customization, goal orientation, and enjoyment, while also emphasizing that therapist supervision remains essential during their rehabilitation process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of stroke survivors regarding factors affecting adoption of technology and exergames for rehabilitation. Krishnan, S., Mandala, MA., Wolf, SL., et al.[2023]

In a study involving 78 children with spastic cerebral palsy, transcutaneous electrical nerve stimulation (TENS) significantly reduced spasticity and improved motor function, including standing and walking, compared to a control group after 6 weeks of treatment.

The TENS group showed statistically significant improvements in clinical assessments of spasticity and walking velocity at 6, 12, and 24 weeks post-treatment, indicating its efficacy as a therapeutic intervention for enhancing motor function in children with spastic CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effects of transcutaneous electrical nerve stimulation on motor function in ambulant children with spastic cerebral palsy: a randomized trial]. Xu, KS., He, L., Li, JL., et al.[2016]

Transcutaneous electrical stimulation (tES) combined with voluntary physical training (vPT) significantly improved upper limb motor functions and reduced muscle spasticity in a patient with traumatic brain injury (TBI), compared to vPT alone.

The study identified that using 1 ms biphasic tES at 30 Hz provided the best motor outputs, highlighting the potential of tES as an effective rehabilitation tool for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restoration of arm and hand functions via noninvasive cervical cord neuromodulation after traumatic brain injury: a case study. Qian, Q., Ling, YT., Zhong, H., et al.[2021]

Spasticity management alone may reduce symptoms of upper motor neuron syndrome but does not necessarily lead to improvements in functional skills, highlighting the need for additional therapies.

A combination of therapy modalities, including neuromuscular electrical stimulation and constraint-induced movement therapy, is essential for enhancing functional outcomes in patients with spasticity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rehabilitation techniques to maximize spasticity management. Logan, LR.[2011]

A review of 37 studies indicates that therapeutic electrical stimulation (ES) can lead to significant improvements in various functional impairments in children, particularly those with cerebral palsy, enhancing muscle strength, range of motion, and walking speed.

Electrical stimulation techniques, such as neuromuscular electrical stimulation (NMES) and functional electrical stimulation (FES), are found to be safe and well-tolerated in pediatric patients, with rare reports of adverse reactions, suggesting their potential for broader clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does therapeutic electrical stimulation improve function in children with disabilities? A comprehensive literature review. Bosques, G., Martin, R., McGee, L., et al.[2022]

The market for functional electrical stimulation (FES) equipment is expanding, with new and innovative products emerging for rehabilitation purposes, including applications for muscle stimulation, cardiovascular exercise, and restoration of function in limbs.

FES technology is also being explored for non-neuromuscular applications, such as controlling epilepsy and enhancing wound healing, indicating its versatility and potential in various medical fields.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the functional electrical stimulation equipment market. O'Malley Teeter, J.[2005]

In a pilot study involving 8 patients with myotonic dystrophy type 1, functional electrical stimulation (FES) training was found to be safe and well-tolerated, leading to significant improvements in muscle strength and endurance compared to conventional training.

FES resulted in a greater increase in tibialis anterior muscle strength (effect size d = 1.583) and overall muscle strength (d = 1.723), suggesting it may be an effective rehabilitative approach for patients with severely compromised muscle function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. Cudia, P., Weis, L., Baba, A., et al.[2018]

A systematic review of literature on neuromuscular electrical stimulation (NMES) identified effective stimulation parameters for treating muscle impairments in conditions like stroke, ACL reconstruction, and knee osteoarthritis, based on a consensus among six Canadian PT experts.

The article serves as a comprehensive resource for physiotherapists, offering evidence-based recommendations and safety tips for the effective application of NMES in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. Nussbaum, EL., Houghton, P., Anthony, J., et al.[2019]

Functional electrical therapy (FET) significantly enhances movement recovery in patients with central nervous system lesions by promoting muscle activation and improving coordination, as evidenced by improved scores on the Upper Extremity Function Test and Functional Independence Measure.

FET not only strengthens the directly stimulated muscles but also improves overall functional ability and proprioception, leading to increased range of motion, reduced spasticity, and better performance in daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurorehabilitation of upper extremities in humans with sensory-motor impairment. Popovic, DB., Popovic, MB., Sinkjaer, T.[2022]

Electromyography (EMG)-initiated electrical muscle stimulation is particularly effective in improving motor function in individuals with hemiparetic arms and hands, with triggered stimulation showing better results than non-triggered methods.

Daily power-assisted functional electrical stimulation (FES) therapy significantly enhances wrist, finger, and shoulder movements, likely due to improved sensory-motor integration and increased blood flow in the brain's sensory-motor cortex during therapy sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Neuro-rehabilitation for neurological disease]. Hara, Y.[2019]

In a study of 81 post-stroke hemiplegic patients, various interventions including mirror therapy and electrical stimulation showed significant improvements in hip and knee joint functions compared to standard training over 4 weeks.

All treatment groups, including those using innovative therapies, demonstrated notable enhancements in ankle joint function, indicating that targeted rehabilitation can effectively aid recovery in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled comparative study on effect of training to improve lower limb motor paralysis in convalescent patients with post-stroke hemiplegia. Kawakami, K., Miyasaka, H., Nonoyama, S., et al.[2020]

High-intensity functional electric stimulation (FES)-assisted exercise therapy (FES-ET) significantly improved motor function in stroke survivors, as measured by the Wolf Motor Function Test (WMFT), compared to low-intensity FES-ET, with a notable effect size of 0.95.

Despite the improvements in objective measures of motor function, self-assessments of motor activity (Motor Activity Log) and overall function (Fugl-Meyer Assessment) did not show significant differences, raising questions about the clinical relevance of the findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. Kowalczewski, J., Gritsenko, V., Ashworth, N., et al.[2016]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of the hybrid of neuromuscular electrical stimulation and noxious thermal stimulation on upper extremity motor recovery in patients with stroke: a randomized controlled trial. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Perceptions of stroke survivors regarding factors affecting adoption of technology and exergames for rehabilitation. [2023]

3. China pubmed.ncbi.nlm.nih.gov

[Effects of transcutaneous electrical nerve stimulation on motor function in ambulant children with spastic cerebral palsy: a randomized trial]. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Restoration of arm and hand functions via noninvasive cervical cord neuromodulation after traumatic brain injury: a case study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Rehabilitation techniques to maximize spasticity management. [2011]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Does therapeutic electrical stimulation improve function in children with disabilities? A comprehensive literature review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A review of the functional electrical stimulation equipment market. [2005]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Neuromuscular Electrical Stimulation for Treatment of Muscle Impairment: Critical Review and Recommendations for Clinical Practice. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Neurorehabilitation of upper extremities in humans with sensory-motor impairment. [2022]

11. Japan pubmed.ncbi.nlm.nih.gov

[Neuro-rehabilitation for neurological disease]. [2019]

12. Japan pubmed.ncbi.nlm.nih.gov

Randomized controlled comparative study on effect of training to improve lower limb motor paralysis in convalescent patients with post-stroke hemiplegia. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Upper-extremity functional electric stimulation-assisted exercises on a workstation in the subacute phase of stroke recovery. [2016]