StrokeNCT03170791
Noninvasive Vagal Nerve Stimulation for Arm Recovery After Stroke
A study testing vagal nerve stimulation intervention in people with Stroke, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study will find out whether electrical stimulation of a nerve called the "vagus" nerve is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20 patients will be recruited if they had a stroke between 4 and 48 months previously and have been left with reduced function in the affected… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- vagal nerve stimulation intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Oct 2015to 1 Feb 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
- Adult (age >18) patients will be invited to take part if they suffered a stroke between 3 months and 2 years previously
- The patient must have moderate to severe upper limb limitation (Upper Extremity Fugl-Meyer score 2050) due to the stroke
- Patients must have a minimum of 10 degrees of active wrist extension, 10 degrees of active thumb abduction/extension and 10 degrees active extension in at least 2 additional digits.
Who cannot join
- Other significant impairment of upper limb e.g. frozen shoulder
- Other diagnosis likely to interfere with rehabilitation/outcome assessments e.g. registered blind
- Patients with insufficient language skills to give informed consent and provide feedback both during the therapy sessions and in a semi structured interview.
- Severe cardiovascular disease or pathological ECG at baseline
- Patients participating in another rehabilitation trial
- Pregnant or trying to get pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF
About this study
Official title: Feasibility and Acceptability of Transcutaneous Vagal Nerve Stimulation in Recovery of Upper Limb Function Post Stroke
This study will find out whether electrical stimulation of a nerve called the "vagus" nerve is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20 patients will be recruited if they had a stroke between 4 and 48 months previously and have been left with reduced function in the affected arm. Patients will receive 3 sessions of physiotherapy per week for 6 weeks. Each session will last 1 hour during which the patient will be asked to perform specific movements e.g. shuffling cards, reaching for a shelf. With each arm movement the therapist will turn on a stimulator which is worn clipped to the patients ear. This will deliver a short burst of electricity creating a mild tingling sensation.
At the end of the session, the stimulator will be removed and the patient will be asked to rate the level of any discomfort or fatigue they experienced as well as any other side effects. The therapist will also record whether the stimulator device interfered with the therapy in any way. A heart tracing will be performed at each visit to check the heart rhythm. At the start and end of the 6 week course of physiotherapy, patients arm weakness and level of arm function will be assessed, as well as their general levels of fatigue, mood and quality of life. These will be reassessed at 1 month and 6 months after the course of physiotherapy has ended. The investigators will also interview patients to establish how they found the treatment itself. If the vagal nerve stimulation combined with physiotherapy is acceptable to patients and therapists and there are no safety concerns, the investigators will plan a larger trial of this treatment in stroke patients.
Read the detailed description
This study will find out whether electrical stimulation of a nerve called the "vagus" nerve is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20 patients will be recruited if they had a stroke between 4 and 48 months previously and have been left with reduced function in the affected arm. Patients will receive 3 sessions of physiotherapy per week for 6 weeks. Each session will last 1 hour during which the patient will be asked to perform specific movements e.g. shuffling cards, reaching for a shelf. With each arm movement the therapist will turn on a stimulator which is worn clipped to the patients ear. This will deliver a short burst of electricity creating a mild tingling sensation.
At the first visit to the Clinical research Facility, the researcher will check that the patient is still happy to take part. Then, some information about the patient e.g. age, sex, date of stroke, risk factors for stroke will be recorded. Next, the therapist will assess how much existing strength and function the patient has in the arm affected by their stroke using a variety of rating scales. Some brief questionnaires will also be used to measure the patients levels of depression, anxiety, fatigue, quality of life and levels of independence.
These initial assessments will take approximately one hour and will be conducted at the first visit, before the exercises commence. Next the research physiotherapist will clean the patients ear using an alcohol wipe then apply the vagal nerve stimulator clip to part of the ear. The stimulator will be set to deliver a burst of electricity which the patient will feel as a tingling sensation that is not uncomfortable.
The exercise session will then commence with a five minute warmup consisting of whole arm movements using equipment such as pedals and cylinders to facilitate activity. The patient will then be asked to perform a range of practical tasks using their weak arm e.g.turning cards, moving objects of various shapes and sizes, opening and closing bottles and bilateral activities such as lifting objects with both hands. The exercise regime will aim to incorporate 300- 400 such arm movements and will take approximately one hour.
During the exercises, the therapist will press a switch to trigger a run of vagal nerve stimulation in time with the patient's activity. Patients will be videoed during the therapy sessions to allow researchers to retrospectively count the number and type of repetitive movements successfully performed. At the end of the exercises, the stimulator clip will be removed from the patient's ear and cleaned with an alcohol disinfectant wipe ready for next use. After each therapy session, patients will be asked to document on scale of 05 how much they experienced skin reddening, irritation, nausea, dizziness, and headache. Patients will be asked to rate their level of discomfort and fatigue arising from the session using a 05 scale.
Patients will also be given a diary to take home to record details of any physiotherapy sessions they undergo outside the study (including any exercise they do at home) and any new symptoms that may arise. They will be asked to bring this diary to the remaining sessions. The patient will undergo 3 of these exercise sessions per week for 6 weeks (i.e. 18 exercise sessions altogether). The remaining 17 session will begin with application of the stimulator clip and the warm up as detailed above. At the end of the final exercise session, the scales used to measure arm strength and function, mood, fatigue and quality of life will be repeated.
Patients will then return to the Clinical Research Facility after 1 month and after 6 months to have their arm function tests repeated and to reassess their mood, quality of life and fatigue. No exercise will be performed at these last 2 visits.
The patients who receive physiotherapy during October- December 2015 will be invited to take part in a separate interview with the MSc student who has been delivering their physiotherapy. This will take place at a mutually convenient time at the Clinical Research Facility. During that interview, the patient will be asked how they found the treatment, whether there were any problems and whether it was what they expected. These interviews will be tape recorded so that the student can listen to the tapes and analyse what the patients have said.
- Conditions
- Stroke
- Being tested
- vagal nerve stimulation intervention
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vagal nerve stimulation interventionDevice
During exercise sessions the therapist will the therapist will press a switch to trigger a run of vagal nerve stimulation in time with the patient's activity. No further activity involved.
| Study group | Role | What they receive |
|---|---|---|
| vagal nerve stimulation intervention | Experimental | All participants consented to the study will undergo an exercise session using equipment such as pedals and cylinders to facilitate activity. During the exercise session the therapist will press a switch to trigger a run of vagal nerve stimulation in time with the patient's activity. Patients will be videoed during the therapy sessions to allow researchers to retrospectively count the number and type of repetitive movements successfully performed. At the end of the exercises, the stimulator clip will be removed from the patient's ear and cleaned with an alcohol disinfectant wipe ready for next use. Receives: Device: vagal nerve stimulation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Safety as measured by patient reported adverse events
Patient safety will be assessed with ECG recordings at each therapy visit, by review of the diary of side effects and investigation of any adverse events.
Measured: 12 months
Secondary outcomes (2)
Acceptability of study
Patient acceptability will be assessed by patient feedback during the qualitative interviews
Measured: 12 months
Feasibility of study as measured by number of completed therapy sessions
Study feasibility will be assessed by review of number of therapy sessions fully completed and the number of repetitive movements achieved in one hour
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start23 Oct 2015
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arshad Majid, Principal investigator, Sheffield Teaching Hospitals NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170791
- Sponsor's protocol ID
- STH19008
- Status last verified
- Sep 2018
- First submitted
- 12 May 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no individual participant data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Transcutaneous Vagal Nerve Stimulation in Recovery of Upper Limb Function Post Stroke
- ClinicalTrials.gov ID
- NCT03170791
- Acronym / sponsor ID
- STH19008
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 23 Oct 2015 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 31 May 2017 (actual)
- 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.
This study will find out whether electrical stimulation of a nerve called the "vagus" nerve is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20 patients will be recruited if they had a stroke between 4 and 48 months previously and have been left with reduced function in the affected arm. Patients will receive 3 sessions of physiotherapy per week for 6 weeks. Each session will last 1 hour during which the patient will be asked to perform specific movements e.g. shuffling cards, reaching for a shelf. With each arm movement the therapist will turn on a stimulator which is worn clipped to the patients ear. This will deliver a short burst of electricity creating a mild tingling sensation.
At the end of the session, the stimulator will be removed and the patient will be asked to rate the level of any discomfort or fatigue they experienced as well as any other side effects. The therapist will also record whether the stimulator device interfered with the therapy in any way. A heart tracing will be performed at each visit to check the heart rhythm. At the start and end of the 6 week course of physiotherapy, patients arm weakness and level of arm function will be assessed, as well as their general levels of fatigue, mood and quality of life. These will be reassessed at 1 month and 6 months after the course of physiotherapy has ended. The investigators will also interview patients to establish how they found the treatment itself. If the vagal nerve stimulation combined with physiotherapy is acceptable to patients and therapists and there are no safety concerns, the investigators will plan a larger trial of this treatment in stroke patients.
Detailed description
This study will find out whether electrical stimulation of a nerve called the "vagus" nerve is acceptable for patients undergoing physiotherapy for arm weakness after a stroke. 20 patients will be recruited if they had a stroke between 4 and 48 months previously and have been left with reduced function in the affected arm. Patients will receive 3 sessions of physiotherapy per week for 6 weeks. Each session will last 1 hour during which the patient will be asked to perform specific movements e.g. shuffling cards, reaching for a shelf. With each arm movement the therapist will turn on a stimulator which is worn clipped to the patients ear. This will deliver a short burst of electricity creating a mild tingling sensation.
At the first visit to the Clinical research Facility, the researcher will check that the patient is still happy to take part. Then, some information about the patient e.g. age, sex, date of stroke, risk factors for stroke will be recorded. Next, the therapist will assess how much existing strength and function the patient has in the arm affected by their stroke using a variety of rating scales. Some brief questionnaires will also be used to measure the patients levels of depression, anxiety, fatigue, quality of life and levels of independence.
These initial assessments will take approximately one hour and will be conducted at the first visit, before the exercises commence. Next the research physiotherapist will clean the patients ear using an alcohol wipe then apply the vagal nerve stimulator clip to part of the ear. The stimulator will be set to deliver a burst of electricity which the patient will feel as a tingling sensation that is not uncomfortable.
The exercise session will then commence with a five minute warmup consisting of whole arm movements using equipment such as pedals and cylinders to facilitate activity. The patient will then be asked to perform a range of practical tasks using their weak arm e.g.turning cards, moving objects of various shapes and sizes, opening and closing bottles and bilateral activities such as lifting objects with both hands. The exercise regime will aim to incorporate 300- 400 such arm movements and will take approximately one hour.
During the exercises, the therapist will press a switch to trigger a run of vagal nerve stimulation in time with the patient's activity. Patients will be videoed during the therapy sessions to allow researchers to retrospectively count the number and type of repetitive movements successfully performed. At the end of the exercises, the stimulator clip will be removed from the patient's ear and cleaned with an alcohol disinfectant wipe ready for next use. After each therapy session, patients will be asked to document on scale of 05 how much they experienced skin reddening, irritation, nausea, dizziness, and headache. Patients will be asked to rate their level of discomfort and fatigue arising from the session using a 05 scale.
Patients will also be given a diary to take home to record details of any physiotherapy sessions they undergo outside the study (including any exercise they do at home) and any new symptoms that may arise. They will be asked to bring this diary to the remaining sessions. The patient will undergo 3 of these exercise sessions per week for 6 weeks (i.e. 18 exercise sessions altogether). The remaining 17 session will begin with application of the stimulator clip and the warm up as detailed above. At the end of the final exercise session, the scales used to measure arm strength and function, mood, fatigue and quality of life will be repeated.
Patients will then return to the Clinical Research Facility after 1 month and after 6 months to have their arm function tests repeated and to reassess their mood, quality of life and fatigue. No exercise will be performed at these last 2 visits.
The patients who receive physiotherapy during October- December 2015 will be invited to take part in a separate interview with the MSc student who has been delivering their physiotherapy. This will take place at a mutually convenient time at the Clinical Research Facility. During that interview, the patient will be asked how they found the treatment, whether there were any problems and whether it was what they expected. These interviews will be tape recorded so that the student can listen to the tapes and analyse what the patients have said.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vagal nerve stimulation intervention | Experimental | Device: vagal nerve stimulation interventionAll participants consented to the study will undergo an exercise session using equipment such as pedals and cylinders to facilitate activity. During the exercise session the therapist will press a switch to trigger a run of vagal nerve stimulation in time with the patient's activity. Patients will be videoed during the therapy sessions to allow researchers to retrospectively count the number and type of repetitive movements successfully performed. At the end of the exercises, the stimulator clip will be removed from the patient's ear and cleaned with an alcohol disinfectant wipe ready for next use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age >18) patients will be invited to take part if they suffered a stroke between 3 months and 2 years previously
- The patient must have moderate to severe upper limb limitation (Upper Extremity Fugl-Meyer score 2050) due to the stroke
- Patients must have a minimum of 10 degrees of active wrist extension, 10 degrees of active thumb abduction/extension and 10 degrees active extension in at least 2 additional digits.
Key exclusion criteria (6 listed)
- Other significant impairment of upper limb e.g. frozen shoulder
- Other diagnosis likely to interfere with rehabilitation/outcome assessments e.g. registered blind
- Patients with insufficient language skills to give informed consent and provide feedback both during the therapy sessions and in a semi structured interview.
- Severe cardiovascular disease or pathological ECG at baseline
- Patients participating in another rehabilitation trial
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 |
|---|---|---|
| vagal nerve stimulation interventionDuring exercise sessions the therapist will the therapist will press a switch to trigger a run of vagal nerve stimulation in time with the patient's activity. No further activity involved. | Device | vagal nerve stimulation intervention |
Primary outcome
Patient Safety as measured by patient reported adverse events
Time frame: 12 months
Patient safety will be assessed with ECG recordings at each therapy visit, by review of the diary of side effects and investigation of any adverse events.
2 secondary outcomes
Acceptability of study
Time frame: 12 months
Feasibility of study as measured by number of completed therapy sessions
Time frame: 12 months
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 7 Sep 2018.
- Individual participant dataSharing planned: No. no individual participant data will be shared
Related trials for Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Arshad Majid 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 vagal nerve stimulation intervention in people with 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 6 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 7 Sep 2018. 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?
Patient Safety as measured by patient reported adverse events (time frame: 12 months). 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 7 Sep 2018.