Electrical Stimuli Perception for Stroke

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

45 Participants Needed

Trial Summary

What is the purpose of this trial?

To successfully manipulate objects in one's surroundings, such as when lifting a cup, one must accurately perceive their physical interactions. This includes accurately interpreting the tactile cues arising at one's fingertips when touching an object. Currently, tactile perception is assessed in individuals with stroke using passive protocols. Research has yet to explore whether activating one's muscles impacts the tactile perceptual process in individuals with stroke despite previous research demonstrating the effect of muscle activation on tactile perception in individuals who are neurologically intact. The proposed research will be the first to address the impact of muscle activation, in addition to stroke, on tactile perception. As such, the proposed research is significant for advancing our understanding of the extent to which tactile deficits occur in individuals with stroke, particularly during volitional movement.

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 data supports the effectiveness of the treatment Perception of Electrical Stimuli for stroke?

Research suggests that electrical stimulation can help improve sensory and motor function in stroke survivors. Studies show that it can assist in rehabilitating sensory deficits and enhance sensorimotor recovery, making it a potentially effective treatment for stroke-related sensory loss. ^{1 2 3 4 5}

Is electrical stimulation safe for stroke patients?

A review of studies on non-invasive electrical stimulation for stroke recovery found that adverse events (unwanted side effects) were documented, but the review did not provide specific details on the frequency or severity of these events. This suggests that while there may be some risks, the treatment is generally considered safe enough to be studied in humans. ^{1 2 3 6 7}

How does the treatment 'Perception of Electrical Stimuli' differ from other treatments for stroke-related sensory deficits?

This treatment is unique because it uses electrical stimulation to provide artificial sensory feedback, helping stroke survivors with sensory deficits perceive tactile stimuli. Unlike traditional therapies, it focuses on restoring the sense of touch by conveying the magnitude of tactile stimuli through electrocutaneous stimulation, which can be adjusted for intensity and frequency to improve sensory perception. ^{1 2 8 9 10}

Eligibility Criteria

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.

Ability to understand and complete the experimental tasks

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

Exclusion Criteria

I experience numbness or tingling in my hands and feet.

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

Timeline

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

Treatment Details

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+

Findings from Research

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]

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]

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 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]

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]

References

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

An initial exploration of the perceptual threshold test using electrical stimulation to measure arm sensation following stroke. [2016]

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

Impaired Discrimination of Electrocutaneous Stimulation in the Paretic Hand of Stroke Survivors. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Difference between the Effects of Peripheral Sensory Nerve Electrical Stimulation on the Excitability of the Primary Motor Cortex: Examination of the Combinations of Stimulus Frequency and Duration. [2023]

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

Cutaneous electrical stimulation may enhance sensorimotor recovery in chronic stroke. [2022]

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

The prevalence and magnitude of impaired cutaneous sensation across the hand in the chronic period post-stroke. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events following Non-invasive Electrical Brain Stimulation in Stroke: A Systematic Review. [2023]

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

Effects of repetitive electrical stimulation to treat sensory loss in persons poststroke. [2016]

8. England pubmed.ncbi.nlm.nih.gov

A new psychometric questionnaire for reporting of somatosensory percepts. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Perceived intensity of somatosensory cortical electrical stimulation. [2021]

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

A neural interface provides long-term stable natural touch perception. [2022]