Electrical Stimuli Perception for Stroke

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Netta Gurari

Disqualifiers: Major arm injury, Sensory neuropathy, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well individuals who have had a stroke can perceive sensations when moving their muscles. It examines whether muscle activation alters the perception of touch, specifically through electrical stimuli. Understanding this could clarify how strokes impact the ability to handle objects, such as lifting a cup. Individuals who experienced a stroke over a year ago and have no other neurological issues are suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance stroke recovery strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for individuals with stroke?

Research has shown that electrical stimulation can safely aid stroke recovery. Studies have found that this stimulation improves movement, especially soon after a stroke. Some individuals might experience tingling, burning, headaches, or fatigue during treatment. These reactions are common but typically mild and resolve on their own.

Other studies suggest that electrical stimulation is not only effective but also safe as an early treatment option, making it a beneficial addition to regular stroke therapy. Overall, evidence indicates that electrical stimulation is well-tolerated, with manageable minor side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of electrical stimuli perception for stroke rehabilitation because it offers a novel approach to aiding recovery. Unlike typical treatments that often involve physical therapy or medication to improve motor functions, this method focuses on stimulating the brain through electrical signals. This could potentially enhance neuroplasticity, which is the brain's ability to reorganize itself, leading to improved recovery outcomes. By directly targeting the brain's perception mechanisms, this technique may offer a faster and more effective way to regain lost functions compared to current standard therapies.

What evidence suggests that the perception of electrical stimuli is effective for stroke?

Research has shown that electrical stimulation can aid in recovering movement after a stroke. A review of 25 studies found that functional electrical stimulation (FES) led to positive results in regaining arm movement. Another study found that electrical stimulation significantly improved ankle movement and scores on movement tests. Improvements in sensation and movement appeared immediately after treatment and lasted for at least four weeks. These findings suggest that electrical stimulation could effectively enhance touch and movement skills in stroke survivors. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had a stroke at least one year ago, affecting only one side of the brain and without other neurological issues. They must be able to understand and perform tasks required by the study and give informed consent. People with sensory nerve damage or major arm injuries cannot participate.

Inclusion Criteria

I had a stroke affecting one side of my brain over a year ago.

I have had a stroke but do not have any other brain-related health issues.

I understand and can agree to the study's procedures and risks.

Exclusion Criteria

I experience numbness or tingling in my hands and feet.

I have had a major injury to one of my arms.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants will detect an externally-applied electrical stimulus at their fingertip under different muscle activation conditions

1 session

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after testing

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Perception of Electrical Stimuli

Trial Overview The study investigates how muscle activation affects tactile perception in individuals who have had a stroke. It aims to advance understanding of touch sensitivity deficits during voluntary movement in these individuals.

Who Is Running the Clinical Trial?

Netta Gurari

Lead Sponsor

Trials

1

Recruited

50+

Virginia Polytechnic Institute and State University

Collaborator

Trials

162

Recruited

26,900+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Published Research Related to This Trial

A new psychometric questionnaire was developed to effectively characterize somatosensory sensations evoked by electrical stimulation in humans, showing strong reliability in a study with 13 subjects.

This questionnaire captured a greater variety of sensory descriptors compared to previous methods, enhancing the understanding of how different electrical stimulation patterns affect sensory perception, which is crucial for improving neural prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new psychometric questionnaire for reporting of somatosensory percepts. Kim, LH., McLeod, RS., Kiss, ZHT.[2019]

Stroke survivors with sensory deficits require significantly higher electrocutaneous stimulation currents (40% more) to perceive tactile stimuli on their affected hand compared to their unaffected hand.

For reliable perception of changes in stimulation intensity, a 140% increase in current is necessary on the paretic hand, indicating that traditional sensory assessments may not accurately reflect the effectiveness of electrocutaneous feedback in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired Discrimination of Electrocutaneous Stimulation in the Paretic Hand of Stroke Survivors. Citterman, AR., Stewart, AE., Urban, RJ., et al.[2023]

Implanted peripheral nerve interfaces provided stable and natural touch sensations in two human subjects with upper limb amputation for over 1 year, demonstrating the potential for long-term sensory restoration.

Electrical stimulation of peripheral nerve cuff electrodes allowed subjects to experience various tactile perceptions, such as tapping and vibration, which improved their ability to control prosthetic grasping strength and manipulate delicate objects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A neural interface provides long-term stable natural touch perception. Tan, DW., Schiefer, MA., Keith, MW., et al.[2022]

A pilot study involving 4 participants with sensory loss post-stroke showed that repetitive electrical stimulation (tactile coactivation) significantly improved sensory discrimination and motor task performance after 6 weeks of treatment.

Improvements in sensory and motor functions were observed immediately after treatment and persisted for at least 4 weeks, suggesting that tactile coactivation could be a promising therapy for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive electrical stimulation to treat sensory loss in persons poststroke. Smith, PS., Dinse, HR., Kalisch, T., et al.[2016]

A systematic review of 75 studies on noninvasive electrical stimulation (ES) in stroke recovery found that adverse events were mostly minor, with tingling being the most common at 18.1% prevalence among participants.

While some adverse events like itching and discomfort were associated with specific stimulation parameters, the overall safety profile of ES appears favorable, with only two severe adverse events reported, indicating it can be a safe therapeutic option for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. Turnbull, C., Boomsma, A., Milte, R., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10739305/

A systematic review on functional electrical stimulation ... The review analyzed 25 studies and found that the use of FES-based rehabilitation systems resulted in favorable outcomes for the stroke recovery of upper limb ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7005350/

Rewiring the Lesioned Brain: Electrical Stimulation for Post ... Conclusions. Electrical stimulation protocols have shown great clinical potential in post-stroke motor recovery. More precise and effective motor restoration ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1052305725000588

Effect of electrical stimulation in the treatment on patients ... The results of the meta-analysis showed that ES can significantly improve the ROM of ankle dorsiflexion and the FMA-LE scores in patients with FD after stroke.

4. withpower.com withpower.com/trial/phase-stroke-1-2022-800a8

Electrical Stimuli Perception for Stroke · Info for Participants Improvements in sensory and motor functions were observed immediately after treatment and persisted for at least 4 weeks, suggesting that tactile coactivation ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04876703

Effectiveness of Multichannel Functional Electrical ... Complete recovery of UE function is only reported in 11.6% of stroke survivors 6 months following ischemic middle cerebral artery stroke (Kwakkel, 2003). Neuro ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11885399/

The Role of Sensory Impairments on Recovery and ... Current evidence has found that sensory and motor systems are interdependent, but commonly have independent recovery trajectories after stroke.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1877065718314088

Adding electrical stimulation during standard rehabilitation ... Electrical sensory input can contribute to routine rehabilitation to improve early post-stroke lower-extremity impairment and late motor function.

8. tandfonline.com tandfonline.com/doi/abs/10.1080/10749357.2022.2058294

Safety and Adverse Events following Non-invasive ... The most frequently reported adverse events were tingling (37.3% of papers), burning (18.7%), headaches (14.7%) and fatigue (14.7%).

9. nature.com nature.com/articles/s41467-025-61948-y

Early intervention with electrical stimulation reduces neural ... These findings suggest that acute electrical stimulation may serve as a safe and effective early intervention, offering a promising therapeutic ...