Noninvasive Vagal Nerve Stimulation for Arm Recovery After Stroke

NCT03170791 | Completed DMC

• 1 other identifier: STH19008
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Acceptability of study

  12 months

• Feasibility of study as measured by number of completed therapy sessions

  12 months

Study Arms (1)

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.

Device: vagal nerve stimulation intervention

Interventions

vagal nerve stimulation intervention DEVICE

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.

vagal nerve stimulation intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Royal Hallamshire Hospital

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Arshad Majid

  Sheffield Teaching Hospitals NHS FT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2017
• First Posted: May 31, 2017
• Study Start: October 23, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)