Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06403475

Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke

Led by Sheffield Teaching Hospitals NHS Foundation Trust · Updated on 2025-12-08

36

Participants Needed

1

Research Sites

140 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 or 2nd or 3rd degree heart block
  • Pregnancy
  • Unable to speak English
  • Severe deafness despite using hearing aids

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom, S10 2JF

Actively Recruiting

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Research Team

D

Dr Ali Ali

CONTACT

M

Miss Samantha Dorney

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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