Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Aphasia, Chronic Stroke

In brief

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.

Key facts

Study ID

NCT06403475

Run by

Sheffield Teaching Hospitals NHS Foundation Trust

People needed

36

Starts

2024-04-25

Expected to finish

2027-01-01

Last updated by the study team

2025-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Implanted devices (e.g. pacemaker) or implanted stimulation devices
• Currently receiving a programme of Speech and Language Therapy (SLT)
• Damage to the vagus nerve
• Symptomatic bradycardia/ 2nd or 3rd heart block
• Pregnancy
• Unable to speak English
• Severe deafness (despite using hear aids)

Where it is running

• Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.