Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke: a Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Aphasia is an acquired language disorder. Stroke is the most common cause of aphasia, which affects 30% of stroke survivors. Speech and Language Therapy (SLT) can help people with aphasia but it may not be provided at the required intensity. Access to therapy is often limited after the first few months following stroke. People with aphasia can improve with therapy many years after stroke but these benefits have not been found to translate to day to day conversation. Transcutaneous Vagus Nerve Stimulation (tVNS) is a non-invasive technique which involves stimulating a branch of the vagus nerve through the skin of the ear, using a small earpiece. This technique is safe and has been approved for use in headache. There is promising evidence that tVNS can improve motor rehabilitation in chronic stroke. This technique may be helpful in aiding language recovery in individuals with chronic aphasia. The current pilot study will primarily assess the feasibility, safety and tolerability of self-directed tVNS paired with computer-based SLT, in individuals with chronic stroke-related aphasia. Secondly, the study aims to explore the effect of the intervention on word-finding ability and to explore potential mechanisms of action. Participants will be randomly allocated to an active or sham tVNS group. Participants will be asked to use the stimulation device at home for 6 weeks, whilst completing computer-based SLT. To date, there are no published studies exploring the use of tVNS in aphasia. An indication of study feasibility may support the development of a larger RCT to explore treatment efficacy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Supratentorial stroke at least 6 months prior to recruitment

• Aphasia (with word finding difficulties)

• Ability to engage in the programme (support can be provided for cognitive or receptive difficulties)

• Sufficient vision to engage in the computer-based SLT programme

Locations
Other Locations
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITING
Sheffield
Contact Information
Primary
Dr Ali Ali
ali.ali@sheffield.ac.uk
01142159114
Backup
Miss Samantha Dorney
sldorney1@sheffield.ac.uk
Time Frame
Start Date: 2024-04-25
Estimated Completion Date: 2027-01-01
Participants
Target number of participants: 36
Treatments
Experimental: Transcutaneous Vagus Nerve Stimulation
The intervention will take place for up to 45 minutes per day, 5 days per week for 6 weeks. The stimulation device will be worn whilst completing computer-based Speech and Language Therapy.
Sham_comparator: Sham Transcutaneous Vagus Nerve Stimulation
The sham intervention will take place for up to 45 minutes per day, 5 days per week for 6 weeks. The device will be in 'sham' mode (attached to the earlobe). The stimulation device will be worn whilst completing computer-based Speech and Language Therapy.
Related Therapeutic Areas
Sponsors
Leads: Sheffield Teaching Hospitals NHS Foundation Trust

This content was sourced from clinicaltrials.gov