Multi-channel Stimulation for Post Stroke Spasticity (MUSTS)

• Research type

  Research Study

• Full title

  Multi-channel Stimulation for Post Stroke Upper Limb Spasticity (MUSTS): A single blind randomised cross over feasibility trial.

• IRAS ID

  202450

• Contact name

  Dipak Patel

• Contact email

  dipak.patel@sth.nhs.uk

• Sponsor organisation

  STH

• Clinicaltrials.gov Identifier

  NCT02907775

• Duration of Study in the UK

  1 years, 6 months, 30 days

• Research summary

  Research 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.(1). One in four patients develop spasticity within the first 2 weeks of the stroke and by 12 months 39 % have spasticity.(2,3) 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%.(4) \nThere are a few exploratory studies on sensory stimulation using Transcutaneous Electrical Nerve Stimulation (TENS) in reducing spasticity. (5-8). Amatya et al reviewed the evidence and concluded that there was not sufficient evidence to recommend its routine use (9). 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.(10) We have developed Shefstim; a unique miniaturised 64 channel electrical stimulator. (11) Using Shefstim we pioneered a technique called Sensory Barrage Stimulation ;rapid simultaneous stimulation at multiple sites, in a constantly changing pattern.(11) We hypothesise that this approach will significantly reduce habituation compared to single site stimulation, thus providing a better treatment for spasticity. \nObjective of the proposed study is to (1)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 (2) to optimise the stimulation parameters through quantifying objectively the muscular response to two different stimulation protocols . \n

  Summary of Results
  Transcutaneous Electrical Nerve Stimulation (TENS) may reduce spasticity. Standard TENS delivers 1-2 channels of constant strength, location and duration stimulation, to which subjects may get habituated. We developed a 64-independent channel sensory stimulator delivering dynamic and varying ‘Sensory Barrage’ Stimulation (SBS). This study’s aim was to assess the feasibility of conducting a clinical trial with caregivers comparing TENS versus SBS for post stroke upper limb spasticity.
  Materials and Methods: In this randomized crossover study, 16 patients with elbow flexion spasticity following stroke sequentially received SBS and TENS for 60 minutes daily for four weeks each, with a washout period of two weeks in between. We trained the caregiver to administer the 60-minute daily interventions. Five outcome measures were tested, namely:
  • Patient-reported Numerical Rating Scale (NRS) for spasticity,
  • Action Research Arm Test,
  • Leeds Arm Spasticity Impact Scale,
  • Modified Ashworth Scale for spasticity in elbow flexor muscles , and
  • Medical Research Council grade of power of elbow flexion and extension.
  Results: Out of 21 potential participants, 16 gave consent and 15 completed the protocol. Ten participants who completed the study did TENS for at least 80% (23/28) of the intended hours. All participants attended all study visits. Eleven participants completed the daily NRS diary record for at least 80% (45/56) of the study days. The remaining outcome measures could be collected from all participants.
  Conclusions: This study demonstrated the feasibility of undertaking a clinical trial comparing sensory electrical stimulation types for post-stroke spasticity with caregivers delivering the intervention in the community.
  

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  16/YH/0169

• Date of REC Opinion

  27 May 2016

• REC opinion

  Further Information Favourable Opinion