MedTrace Logo

Multi-channel Stimulation for Post Stroke Spasticity (MUSTS)

NCT02907775 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-07-18

No results posted yet for this study

Summary

Over 87,000 people have a first stroke in the UK each year; about 70% of victims have altered arm function and about 40% are left with a non-functional arm. Spasticity is a significant deterrent for recovery of arm function following stroke. One in four patients develop spasticity within the first 2 weeks of the stroke and by 12 months 39 % have spasticity. The use of oral antispasticity medications like baclofen and tizanidine are often restricted due to side effects like sedation, weakness and floppiness. Compliance of adults to treatment with oral anti spasticity drugs is only around 50%.

There are a few exploratory studies on sensory stimulation using Transcutaneous Electrical Nerve Stimulation (TENS) in reducing spasticity. Amatya et al reviewed the evidence and concluded that there was not sufficient evidence to recommend its routine use. One possible explanation for the ineffectiveness of TENS is that it uses a single channel, single strength and fixed duration stimulation to which the nervous system may get habituated. We have developed Shefstim; a unique miniaturised 64 channel electrical stimulator. Using Shefstim we pioneered a technique called Sensory Barrage Stimulation ;rapid simultaneous stimulation at multiple sites, in a constantly changing pattern. We hypothesise that this approach will significantly reduce habituation compared to single site stimulation, thus providing a better treatment for spasticity.

Objective of the proposed study is to to explore the feasibility of conducting a community based randomised cross over trial comparing SBS with TENS for post stroke upper limb the spasticity of elbow flexors to optimise the stimulation parameters through quantifying objectively the muscular response to two different stimulation protocols.

Conditions

Interventions

DEVICE

ShefStim

Electrode arrays will be worn over the affected arm with stimulation applied over the extensor aspect of the upper arm

DEVICE

Electrodes

electrodes placed over the radial nerve in radial grove

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Siva Nair · Sheffield Teaching Hospitals NHS FT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02907775 on ClinicalTrials.gov