Clinical Trials Directory

Trials / Suspended

SuspendedNCT06357247

The Effect of SRS on Hemiplegia in Stroke Survivors

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

Status
Suspended
Phase
N/A
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
Virginia Commonwealth University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
DEVICESensory 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
BEHAVIORALNine 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.
BEHAVIORALSemmes 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.

Timeline

Start date
2024-03-04
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2024-04-10
Last updated
2026-02-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06357247. Inclusion in this directory is not an endorsement.