Muscle SpasticityMUSTSNCT02907775
Multi-channel Stimulation for Post Stroke Spasticity (MUSTS)
A study testing ShefStim and Electrodes in people with Muscle Spasticity and Stroke, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Muscle Spasticity, Stroke
- What is being tested?
- ShefStim and Electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Sep 2016to 30 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and above;
- Six months after stroke;
- Spasticity at elbow of grade-2 or more on the modified Ashworth scale.
Who cannot join
- 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;
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- Within 12 weeks of receiving Botulinum toxin injections;
- Uncontrolled epilepsy;
- Pace maker or any other implanted devices;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-channel Stimulation for Post Stroke Spasticity (MUSTS): A Randomised Controlled Cross Over Feasibility Trial
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.
Read the detailed description
We will assess the safety and feasibility of delivering SBS and TENS for upper limb spasticity in the community. The trial is considered single blind as the assessor will be blinded as to the intervention. The investigator delivering the intervention cannot be blinded but will not be involved in the assessment of outcomes.
Twenty men and women will be randomised to receive either SBS or TENS. Participants will be identified from the stroke clinics, Community physiotherapy services, Assessment and Rehabilitation Centre and Functional Electrical Stimulation clinic in Sheffield. The treating team will identify the potential participants and will give them the information leaflet about the study. A member of the study team will then contact the participants between 7 and 14 days. Those who agree to participate in the study will be invited to attend a face to face appointment with a member of the study team at Royal Hallamshire Hospital.
Visit-1: During this visit the participant will be given opportunity to discuss the study and any concerns regarding the trial with the principal investigator. After this principal investigator will obtain the informed consent.
The participant will be asked to perform Action Research Arm test ( ARAT) which include a set of activities like grasping, holding and lifting objects with both affected and unaffected arms while we record the activity of 16 arm muscles using electromyography and motion sensors. This involves sticking small sensors on various muscles. The participant will then receive two different paradigms of SBS for 10 minutes each with a gap of 10 minutes in between and the effect on EMG will be recorded. The participant or carer will be trained to record the severity of spasticity in a diary between 6pm and 9pm on a scale ranging from 0 to 10; 0- no spasticity, 10 worst spasticity you can imagine.
Visit-2: The participant will be randomly allocated to either group-1 or group-2 using an online randomisation system. A researcher is blind to the allocation will do the assessments. Another researcher will deliver the intervention. Participants in group-1 will receive TENS and those in group-2 will revive SBS over extensor aspect of upper arm for one hour. The strength for stimulation will be just below the motor threshold or the maximum tolerable stimulation which ever is lower. The stimulation can cause a tingling sensation. Some people may find these stimulations slightly unpleasant. The researcher will again assess and will also look for any adverse event after the intervention. Participant or carer will be trained to apply the electrodes and deliver the intervention for 1 hour a day for next 4 weeks.
Visit 3: The researcher will again assess the participants and will also look for any adverse event after the intervention. Participant\carer will be asked to continue to record the severity of spasticity in a diary for next one week.
Visit-4: After assessment the participants in group-1 will receive TENS and in group-2 will receive SBS for one hour. As during the visit 2, the blinded researcher will check for any adverse events and assess the outcome measures after the stimulation. The participant or carer will be trained to apply the electrodes and deliver the intervention for 1 hour a day for next 4 weeks.
Visit 5: The blinded researcher will again assess the outcome measures and will also look for any adverse event after the intervention.
Interventions: This will occur in three phases.
Phase 1: Subjects will randomly be allocated to Group-1 to receive TENS, or Group-2 to receive SBS, for 60 minutes each day for four weeks. We will use a remote randomisation through telephone.
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 and \or the carer 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. He \she 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 Royal Hallamshire Hospital.
The researcher-2 will collect all the electrodes and the equipment back. The researcher-1 will do all the outcome assessments.
Phase 2: No intervention period of two weeks.
Phase 3: Group-1 to receive SBS, or Group-2 to receive TENS, for 60 minutes each day for four weeks.
The first session of SBS and TENS will take place in Royal Hallamshire Hospital.
SBS group: We will use the stimulation techniques tested out in our previous study. Electrode arrays will be worn over the affected arm with stimulation applied over the extensor aspect of the upper arm. At the start of first session, stimulation will be increased over the arrays until movement is first observed. The stimulation level will then be set at 90% of this value, or the maximum tolerable if pain is reported and the value recorded. Stimulation will continue at this level moving around the array electrodes with a pseudo-random pattern for 60 minutes daily for 4 weeks. TENS group: We will use the stimulation techniques tested out in the previous studies, including our trial. Two surface electrodes will be placed over the radial nerve in radial grove. The intensity of stimulation will be set to 90% of the motor threshold. TENS will be applied for 60 minutes daily for 4 weeks.
- Conditions
- Muscle Spasticity, Stroke
- Being tested
- ShefStim, Electrodes
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ShefStimDevice
Electrode arrays will be worn over the affected arm with stimulation applied over the extensor aspect of the upper arm
ElectrodesDevice
electrodes placed over the radial nerve in radial grove
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: ShefStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
upper limb function after four weeks of intervention measured by the Action Research Arm Test
Measured: 4 weeks
Secondary outcomes (4)
muscle activity as measured using EMG
Measured: 4 weeks
measures of muscle tone
Modified Ashworth Scale
Measured: 4 weeks
strength
Medical Research Council grading
Measured: 4 weeks
impact of spasticity
Leeds Arm Spasticity Scale-reference
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study start30 Sep 2016
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Siva Nair, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02907775
- Sponsor's protocol ID
- STH19263
- Acronym
- MUSTS
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2016
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-channel Stimulation for Post Stroke Spasticity (MUSTS): A Randomised Controlled Cross Over Feasibility Trial
- ClinicalTrials.gov ID
- NCT02907775
- Acronym / sponsor ID
- MUSTS / STH19263
- Conditions
- Muscle Spasticity, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 30 Sep 2016 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We will assess the safety and feasibility of delivering SBS and TENS for upper limb spasticity in the community. The trial is considered single blind as the assessor will be blinded as to the intervention. The investigator delivering the intervention cannot be blinded but will not be involved in the assessment of outcomes.
Twenty men and women will be randomised to receive either SBS or TENS. Participants will be identified from the stroke clinics, Community physiotherapy services, Assessment and Rehabilitation Centre and Functional Electrical Stimulation clinic in Sheffield. The treating team will identify the potential participants and will give them the information leaflet about the study. A member of the study team will then contact the participants between 7 and 14 days. Those who agree to participate in the study will be invited to attend a face to face appointment with a member of the study team at Royal Hallamshire Hospital.
Visit-1: During this visit the participant will be given opportunity to discuss the study and any concerns regarding the trial with the principal investigator. After this principal investigator will obtain the informed consent.
The participant will be asked to perform Action Research Arm test ( ARAT) which include a set of activities like grasping, holding and lifting objects with both affected and unaffected arms while we record the activity of 16 arm muscles using electromyography and motion sensors. This involves sticking small sensors on various muscles. The participant will then receive two different paradigms of SBS for 10 minutes each with a gap of 10 minutes in between and the effect on EMG will be recorded. The participant or carer will be trained to record the severity of spasticity in a diary between 6pm and 9pm on a scale ranging from 0 to 10; 0- no spasticity, 10 worst spasticity you can imagine.
Visit-2: The participant will be randomly allocated to either group-1 or group-2 using an online randomisation system. A researcher is blind to the allocation will do the assessments. Another researcher will deliver the intervention. Participants in group-1 will receive TENS and those in group-2 will revive SBS over extensor aspect of upper arm for one hour. The strength for stimulation will be just below the motor threshold or the maximum tolerable stimulation which ever is lower. The stimulation can cause a tingling sensation. Some people may find these stimulations slightly unpleasant. The researcher will again assess and will also look for any adverse event after the intervention. Participant or carer will be trained to apply the electrodes and deliver the intervention for 1 hour a day for next 4 weeks.
Visit 3: The researcher will again assess the participants and will also look for any adverse event after the intervention. Participant\carer will be asked to continue to record the severity of spasticity in a diary for next one week.
Visit-4: After assessment the participants in group-1 will receive TENS and in group-2 will receive SBS for one hour. As during the visit 2, the blinded researcher will check for any adverse events and assess the outcome measures after the stimulation. The participant or carer will be trained to apply the electrodes and deliver the intervention for 1 hour a day for next 4 weeks.
Visit 5: The blinded researcher will again assess the outcome measures and will also look for any adverse event after the intervention.
Interventions: This will occur in three phases.
Phase 1: Subjects will randomly be allocated to Group-1 to receive TENS, or Group-2 to receive SBS, for 60 minutes each day for four weeks. We will use a remote randomisation through telephone.
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 and \or the carer 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. He \she 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 Royal Hallamshire Hospital.
The researcher-2 will collect all the electrodes and the equipment back. The researcher-1 will do all the outcome assessments.
Phase 2: No intervention period of two weeks.
Phase 3: Group-1 to receive SBS, or Group-2 to receive TENS, for 60 minutes each day for four weeks.
The first session of SBS and TENS will take place in Royal Hallamshire Hospital.
SBS group: We will use the stimulation techniques tested out in our previous study. Electrode arrays will be worn over the affected arm with stimulation applied over the extensor aspect of the upper arm. At the start of first session, stimulation will be increased over the arrays until movement is first observed. The stimulation level will then be set at 90% of this value, or the maximum tolerable if pain is reported and the value recorded. Stimulation will continue at this level moving around the array electrodes with a pseudo-random pattern for 60 minutes daily for 4 weeks. TENS group: We will use the stimulation techniques tested out in the previous studies, including our trial. Two surface electrodes will be placed over the radial nerve in radial grove. The intensity of stimulation will be set to 90% of the motor threshold. TENS will be applied for 60 minutes daily for 4 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electric Nerve Stimulus | Active comparator | Device: ElectrodesResearcher 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. |
| Sensory Barrage Stimulation | Active comparator | Device: ShefStimResearcher 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 and above;
- Six months after stroke;
- Spasticity at elbow of grade-2 or more on the modified Ashworth scale.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ShefStimElectrode arrays will be worn over the affected arm with stimulation applied over the extensor aspect of the upper arm | Device | Sensory Barrage Stimulation |
| Electrodeselectrodes placed over the radial nerve in radial grove | Device | Transcutaneous Electric Nerve Stimulus |
Primary outcome
upper limb function after four weeks of intervention measured by the Action Research Arm Test
Time frame: 4 weeks
4 secondary outcomes
muscle activity as measured using EMG
Time frame: 4 weeks
measures of muscle tone
Time frame: 4 weeks
strength
Time frame: 4 weeks
impact of spasticity
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siva Nair principal investigator
Sheffield Teaching Hospitals NHS FT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ShefStim and Electrodes in people with Muscle Spasticity and Stroke, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
upper limb function after four weeks of intervention measured by the Action Research Arm Test (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.