Stroke Clinical Trial
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.
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.
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