StrokeNCT06357247
The Effect of SRS on Hemiplegia in Stroke Survivors
A study testing Sensory Threshold, Nine Hole Peg Test and Semmes Weinstein Monofilament Assessment in people with Stroke, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Sensory Threshold, Nine Hole Peg Test and Semmes Weinstein Monofilament Assessment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stroke survivors over the age of 18
- At least six months post stroke
- Ability to provide verbal informed consent and written informed consent
- Score of at least 56 on the Fugl meyer assessment total motor scores
- Able to detect at least 6.65 (300 grams) on the Semmes Weinstein monofilament on both the pads of the thumb and index finger
- Able to complete the nine hole peg test
- Able to reliably express pain, discomfort, or fear
- Speak english
Who cannot join
- History of upper extremity orthopedic conditions, such as arthritis, surgery, etc.
- Aphasia caused by stroke
- Does not have AROM
- Currently have muscle contractures in upper extremity
- Participating in other research studies
- Patients with electrically operated implanted device (e.g. cardiac pacemaker/defibrillator, drug delivery pump, and neurostimulator)
Show all 9Show fewer
- History of SMI (e.g. schizophrenia, schizoaffective disorder)
- History of neurodegenerative disability (e.g. Multiple Sclerosis, Parkinson's Disease)
- Have received botulinum injections in the paretic limb within the past three months
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 232398
About this study
Official title: The Effect of SRS on Hemiplegia in Stroke Survivors: A Feasibility Study
Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors.
Read the detailed description
A novel intervention that has shown immediate improvements in tactile sensation is called stochastic resonance stimulation. SRS is a phenomenon where cutaneous sensation can be enhanced with the presence of tactile noise in a nonlinear system. This theory suggests that the application of an imperceptible vibrotactile stimulation increases the synchronization of afferent neurons firing to the somatosensory cortex, ultimately increasing the excitability of mechanoreceptors in the skin suggesting that afferent signals from the periphery to the somatosensory cortex influence motor movements. However, more research is needed to document the changes in motor performance with the use of SRS and it is unclear how SRS stimulation changes different measurable sensory processing differences
- Conditions
- Stroke
- Being tested
- Sensory Threshold, Nine Hole Peg Test, Semmes Weinstein Monofilament Assessment
- Keywords
- SRS- stochastic resonance stimulation, SR- stochastic resonance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory ThresholdDevice
Using a light, vibrotactile noise device on the participant's affected wrist. The actuator will be positioned on both the dorsal and volar sides of the wrist. Each participant's sensory threshold will be measured using the method of ascending and descending limits
Nine Hole Peg TestBehavioural
The Nine-Hole Peg Test (NHPT) is considered as a gold standard measure of manual dexterity and most frequently used in MS research and clinical practice. The score for the 9-HPT is an average of the four trials. The two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged. On average, healthy male adults complete the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand.
Semmes Weinstein Monofilament AssessmentBehavioural
A non-invasive, low-cost, simple, and accurate handheld calibrated nylon thread that buckles once it has delivered a force of 10 g. It provides a standardized measure of a patient's ability to sense a point of pressure. The filaments are classified from grade 1 to 5 according to their thickness: 1.65-2.83 = grade 5, 3.22-3.61 = grade 4, 3.84-4.31 = grade 3, 4.56-6.45 = grade 2, and 6.65 = grade 1.
| Study group | Role | What they receive |
|---|---|---|
| Feasibility Arm | Experimental | Wearing a stochastic resonance device at home in chronic stroke patients (six months or more post stroke). Receives: Device: Sensory Threshold; Behavioral: Nine Hole Peg Test; Behavioral: Semmes Weinstein Monofilament Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients
To determine the feasibility of wearing a stochastic resonance device at home in chronic stroke patients. This is administered through a participant questionnaire. Some questions are point-based (scale of 1-5), and some are open-ended questions. A good score is considered to be a higher signal-to-noise ratio, indicating better performance and detection capabilities
Measured: Six months post stroke
Secondary outcomes (1)
Optimal level of stochastic resonance vibration
To determine the optimal level of stochastic resonance vibration (120% vs 90% vs 60% of detection threshold) in stroke survivors
Measured: Six months post stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start4 Mar 2024
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Why it stopped: Feasibility and Funding, Planning to start enrolling again in early 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginia Chu, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357247
- Sponsor's protocol ID
- HM20027093
- Status last verified
- May 2026
- First submitted
- 13 Mar 2024
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of SRS on Hemiplegia in Stroke Survivors: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06357247
- Acronym / sponsor ID
- HM20027093
- Conditions
- Stroke
- Keywords
- SRS- stochastic resonance stimulation, SR- stochastic resonance
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Feasibility and Funding, Planning to start enrolling again in early 2025
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 10 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Strokes are one of the leading causes of long term disability and death in the United States. A stroke occurs when the blood supply to the brain is blocked, damaging parts of the brain. Many stroke survivors have difficulty completing dexterous hand movements and manipulating objects due brain damage in the sensorimotor cortex. Damage to these areas can cause decreased motor movements and tactile sensation on the affected side. Research shows that tactile sensation is necessary for maintaining grip, grading grip forces and decreasing object slippage. Therefore, it is important to address tactile sensation with motor performance during stroke rehabilitation to improve performance outcomes among stroke survivors.
Detailed description
A novel intervention that has shown immediate improvements in tactile sensation is called stochastic resonance stimulation. SRS is a phenomenon where cutaneous sensation can be enhanced with the presence of tactile noise in a nonlinear system. This theory suggests that the application of an imperceptible vibrotactile stimulation increases the synchronization of afferent neurons firing to the somatosensory cortex, ultimately increasing the excitability of mechanoreceptors in the skin suggesting that afferent signals from the periphery to the somatosensory cortex influence motor movements. However, more research is needed to document the changes in motor performance with the use of SRS and it is unclear how SRS stimulation changes different measurable sensory processing differences
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility Arm | Experimental | Device: Sensory Threshold, Behavioral: Nine Hole Peg Test, Behavioral: Semmes Weinstein Monofilament AssessmentWearing a stochastic resonance device at home in chronic stroke patients (six months or more post stroke). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Stroke survivors over the age of 18
- At least six months post stroke
- Ability to provide verbal informed consent and written informed consent
- Score of at least 56 on the Fugl meyer assessment total motor scores
- Able to detect at least 6.65 (300 grams) on the Semmes Weinstein monofilament on both the pads of the thumb and index finger
Key exclusion criteria (9 listed)
- History of upper extremity orthopedic conditions, such as arthritis, surgery, etc.
- Aphasia caused by stroke
- Does not have AROM
- Currently have muscle contractures in upper extremity
- Participating in other research studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sensory ThresholdUsing a light, vibrotactile noise device on the participant's affected wrist. The actuator will be positioned on both the dorsal and volar sides of the wrist. Each participant's sensory threshold will be measured using the method of ascending and descending limits | Device | Feasibility Arm |
| Nine Hole Peg TestThe Nine-Hole Peg Test (NHPT) is considered as a gold standard measure of manual dexterity and most frequently used in MS research and clinical practice. The score for the 9-HPT is an average of the four trials. The two trials for each hand are averaged, converted to the reciprocals of the mean times for each hand and then the two reciprocals are averaged. On average, healthy male adults complete the NHPT in 19.0 seconds (SD 3.2) with the right hand, and in 20.6 seconds (SD 3.9) with the left hand. | Behavioural | Feasibility Arm |
| Semmes Weinstein Monofilament AssessmentA non-invasive, low-cost, simple, and accurate handheld calibrated nylon thread that buckles once it has delivered a force of 10 g. It provides a standardized measure of a patient's ability to sense a point of pressure. The filaments are classified from grade 1 to 5 according to their thickness: 1.65-2.83 = grade 5, 3.22-3.61 = grade 4, 3.84-4.31 = grade 3, 4.56-6.45 = grade 2, and 6.65 = grade 1. | Behavioural | Feasibility Arm |
Primary outcome
Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients
Time frame: Six months post stroke
To determine the feasibility of wearing a stochastic resonance device at home in chronic stroke patients. This is administered through a participant questionnaire. Some questions are point-based (scale of 1-5), and some are open-ended questions. A good score is considered to be a higher signal-to-noise ratio, indicating better performance and detection capabilities
1 secondary outcome
Optimal level of stochastic resonance vibration
Time frame: Six months post stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia Chu principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory Threshold, Nine Hole Peg Test and Semmes Weinstein Monofilament Assessment in people with Stroke, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Scores on ease of use, duration of wear, and preference related to wearing a stochastic resonance device at home in chronic stroke patients (time frame: Six months post stroke). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.