Noninvasive Vagal Nerve Stimulation for Arm Recovery After Stroke
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|ClinicalTrials.gov Identifier: NCT03170791|
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : June 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: vagal nerve stimulation intervention||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|Official Title:||Feasibility and Acceptability of Transcutaneous Vagal Nerve Stimulation in Recovery of Upper Limb Function Post Stroke|
|Actual Study Start Date :||October 23, 2015|
|Estimated Primary Completion Date :||February 1, 2018|
|Estimated Study Completion Date :||February 1, 2018|
Experimental: vagal nerve stimulation intervention
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.
Device: vagal nerve stimulation intervention
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.
- 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.
- Acceptability of study [ Time Frame: 12 months ]Patient acceptability will be assessed by patient feedback during the qualitative interviews
- Feasibility of study as measured by number of completed therapy sessions [ Time Frame: 12 months ]Study feasibility will be assessed by review of number of therapy sessions fully completed and the number of repetitive movements achieved in one hour
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170791
|Contact: Jessica Redgravefirstname.lastname@example.org|
|Contact: Jodie Keyworth||Jodie.Keyworth@sth.nhs.uk|
|Royal Hallamshire Hospital||Recruiting|
|Sheffield, South Yorkshire, United Kingdom, S10 2JF|
|Contact: Jodie Keyworth email@example.com|
|Principal Investigator:||Arshad Majid||Sheffield Teaching Hospitals NHS FT|