The Effect of SRS on Hemiplegia in Stroke Survivors

Stroke Clinical Trial

Official title:

The Effect of SRS on Hemiplegia in Stroke Survivors: A Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06357247
• Other study ID #: HM20027093
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: August 2024

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: Virginia Chu
• Phone: (804) 828-1564
• Email: vchu[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• 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

Related Conditions & MeSH terms

• Hemiplegia
• Stroke

Intervention

Device:
• Sensory Threshold
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

Behavioral:
• Nine Hole Peg Test
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 Assessment
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 question answers.	Six months post stroke
Secondary	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	Six months post stroke