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Noninvasive Vagal Nerve Stimulation for Arm Recovery After Stroke

This study is currently recruiting participants.
Verified June 2017 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
ClinicalTrials.gov Identifier:
NCT03170791
First Posted: May 31, 2017
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
  Purpose

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 Intervention
Stroke Device: vagal nerve stimulation intervention

Study Type: Interventional
Study Design: 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

Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 20
Actual Study Start Date: October 23, 2015
Estimated Study Completion Date: February 1, 2018
Estimated Primary Completion Date: February 1, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Jessica Redgrave jessica.redgrave@sth.nhs.uk
Contact: Jodie Keyworth Jodie.Keyworth@sth.nhs.uk

Locations
United Kingdom
Royal Hallamshire Hospital Recruiting
Sheffield, South Yorkshire, United Kingdom, S10 2JF
Contact: Jodie Keyworth       jodie.keyworth@sth.nhs.uk   
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Arshad Majid Sheffield Teaching Hospitals NHS FT
  More Information

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03170791     History of Changes
Other Study ID Numbers: STH19008
First Submitted: May 12, 2017
First Posted: May 31, 2017
Last Update Posted: June 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no individual participant data will be shared

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases