The Effect of SRS on Hemiplegia in Stroke Survivors

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Sensory Threshold; Behavioral: Nine Hole Peg Test; Behavioral: Semmes Weinstein Monofilament Assessment

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Virginia Chu; Phone Number: (804) 828-1564; Email: vchu@vcu.edu

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 232398
      • Recruiting
      • Virginia Commonwealth University
      • Contact: Virginia Chu; Phone Number: 804-828-1564; Email: vchu@vcu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Feasibility Arm; Wearing a stochastic resonance device at home in chronic stroke patients (six months or more post stroke).

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.; Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Virginia Chu, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2024
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: April 4, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: SRS- stochastic resonance stimulation; SR- stochastic resonance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: HM20027093

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No