NCT06403475Recruiting
Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke
Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke: a Pilot Study
Source: ClinicalTrials.gov · Last updated 8 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 3 May 2024
- Start date
- 25 Apr 2024
- Primary completion date
- 3 Jun 2026
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Diseases
- Stroke
- NCT number
- NCT06403475
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 25 Apr 2024 to the primary completion date, 3 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving a programme of Speech and Language Therapy (SLT)
Other illness
- Symptomatic bradycardia/ 2nd or 3rd heart block
Other
- Implanted devices (e.g. pacemaker) or implanted stimulation devices
- Damage to the vagus nerve
- Pregnancy
- Unable to speak English
- Severe deafness (despite using hear aids)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.