Multi-channel Stimulation for Post Stroke Spasticity (MUSTS)

NCT02907775 | Completed

• 1 other identifier: STH19263
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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

Muscle Spasticity; Stroke

Outcome Measures

Primary Outcomes (1)

• upper limb function after four weeks of intervention measured by the Action Research Arm Test

  4 weeks

Secondary Outcomes (4)

• muscle activity as measured using EMG

  4 weeks

• measures of muscle tone

  4 weeks

• strength

  4 weeks

• impact of spasticity

  4 weeks

Study Arms (2)

Transcutaneous Electric Nerve Stimulus

ACTIVE COMPARATOR

Researcher 1 who is blind to patients' allocation group will perform the baseline assessments. The researcher 2 will determine the maximum tolerable level of stimulation. The researcher 2 will demonstrate to the participant how to apply the stimulation and will instruct the participant. The participant will revive the first intervention in the Royal Hallamshire Hospital under supervision of researcher 2. The researcher 2 will then issue the participants in Group-2 (SBS) with Shefstim and six multichannel electrodes. They will instruct each participant to change the electrode once every 3 days. On the 15th day the researcher 2 will visit them at home and issue further 6 multichannel electrodes and collect back the previous set. At the end of week 4, the patient will come to Hospital.

Device: Electrodes

Sensory Barrage Stimulation

ACTIVE COMPARATOR

Researcher 1 who is blind to patients' allocation group will perform the baseline assessments. The researcher 2 will determine the maximum tolerable level of stimulation. The researcher 2 will demonstrate to the participant how to apply the stimulation and will instruct the participant. The participant will revive the first intervention in the Royal Hallamshire Hospital under supervision of researcher 2. The researcher 2 will then issue the participants in Group-2 (SBS) with Shefstim and six multichannel electrodes. They will instruct each participant to change the electrode once every 3 days. On the 15th day the researcher 2 will visit them at home and issue further 6 multichannel electrodes and collect back the previous set. At the end of week 4, the patient will come to Hospital.

Device: ShefStim

Interventions

ShefStim DEVICE

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

Sensory Barrage Stimulation

Electrodes DEVICE

electrodes placed over the radial nerve in radial grove

Transcutaneous Electric Nerve Stimulus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above;
• Six months after stroke;
• Spasticity at elbow of grade-2 or more on the modified Ashworth scale.

You may not qualify if:

• Cognitive impairment that would interfere with their ability to comply with the experimental protocol or provide informed consent;
• Dermatological, rheumatologic or orthopaedic illnesses of the affected arm interfering with movement of the elbow;
• Pre-existing severe systemic disorders like cardiovascular disease; active cancer or renal disease; end stage pulmonary or cardiovascular disease; psychiatric illness including severe alcohol or drug abuse and depression;
• Inability to perform the baseline assessments;
• Severe tactile hypersensitivity;
• Participation in other, spasticity related studies;
• Within 12 weeks of receiving Botulinum toxin injections;
• Uncontrolled epilepsy;
• Pace maker or any other implanted devices;
• Pregnancy.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS FT

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Interventions

Electrodes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Siva Nair

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2016
• First Posted: September 20, 2016
• Study Start: September 30, 2016
• Primary Completion: September 30, 2018
• Study Completion: September 30, 2018
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)