Stroke Clinical Trial
Official title:
Feasibility and Acceptability of Transcutaneous Vagal Nerve Stimulation in Recovery of Upper Limb Function Post Stroke
Verified date | September 2018 |
Source | Sheffield Teaching Hospitals NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 5 |
Est. completion date | February 1, 2018 |
Est. primary completion date | February 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Hallamshire Hospital | Sheffield | South Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Sheffield Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 12 months | |
Secondary | Acceptability of study | Patient acceptability will be assessed by patient feedback during the qualitative interviews | 12 months | |
Secondary | 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 | 12 months |
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