Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSheffield Teaching Hospitals NHS Foundation Trust

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Transcutaneous Vagus Nerve Stimulation
  • Sham Transcutaneous Vagus Nerve Stimulation
  • Computer Based Speech and Language Therapy (Step by Step)

Treatment groups

36 Participants
are divided into 2 treatment groups