Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke

NCT06403475 | Recruiting

• 1 other identifier: STH22935
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aphasia; Chronic Stroke

Keywords

aphasia; vagus nerve stimulation; stroke; transcutaneous vagus nerve stimulation

Outcome Measures

Primary Outcomes (3)

• Safety: The number of adverse events reported that are associated with tVNS

  The safety of using tVNS in the aphasia population will be measured through the recording of adverse events. The number of Serious Adverse Events (SAE's) and Unexpected Adverse Events (UAE's) during the intervention will be reported.

  6 weeks

• Tolerability: The number and intensity of symptoms reported

  The reporting of symptoms associated with tVNS will be recorded and the severity of each symptom on a 1-5 scale (1= mild; 5 = severe).

  6 weeks

• Percentage of participants completing the study intervention and outcome measures

  \>80% of recruited participants completing the intervention and primary outcome measures at 6 weeks

  24 months

Secondary Outcomes (7)

• Picture Naming (personally relevant)

  Week 0; Week 6; Week 12

• The Comprehensive Aphasia Test (CAT): Naming Objects

  Week 0; Week 6; Week 12

• Conversation: The number of trained words used in conversation

  Week 0; Week 6; Week 12

• Brain Derived Neurotrophic Factor (BDNF) (ng/ml)

  Week 0; Week 6

• Inflammatory markers (pg/ml)

  Week 0; Week 6

Study Arms (2)

Transcutaneous Vagus Nerve Stimulation

EXPERIMENTAL

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.

Device: Transcutaneous Vagus Nerve Stimulation; Behavioral: Computer Based Speech and Language Therapy (Step by Step)

Sham Transcutaneous Vagus Nerve Stimulation

SHAM COMPARATOR

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. The stimulation device will be worn whilst completing computer-based Speech and Language Therapy.

Device: Sham Transcutaneous Vagus Nerve Stimulation; Behavioral: Computer Based Speech and Language Therapy (Step by Step)

Interventions

Transcutaneous Vagus Nerve Stimulation DEVICE

Transcutaneous auricular vagus nerve stimulation using the Nurosym (Parasym Ltd) device. Stimulation parameters: Pulse width: 250µs; Frequency: 25Hz; Intensity: Below pain threshold. The active stimulation will be delivered to the left ear. Participants will complete the intervention at home once they have received sufficient training on how to use the stimulation device.

Transcutaneous Vagus Nerve Stimulation

Sham Transcutaneous Vagus Nerve Stimulation DEVICE

Stimulation will be delivered at the same parameters however, sham stimulation will be delivered to the left ear. This sham method has been used as a sham in other studies as it is not thought to activate the vagus nerve.

Sham Transcutaneous Vagus Nerve Stimulation

Computer Based Speech and Language Therapy (Step by Step) BEHAVIORAL

Computer-based Speech and Language Therapy will be completed whilst wearing the stimulation device in all groups. The Step by Step programme uses an errorless learning approach to practice naming. All participants will practice a set of 30 meaningful words during the intervention. Participants will complete the SLT programme at home on an ipad, whilst using the stimulation device.

Sham Transcutaneous Vagus Nerve Stimulation; Transcutaneous Vagus Nerve Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

RECRUITING

Related Publications (2)

• Palmer R, Dimairo M, Cooper C, Enderby P, Brady M, Bowen A, Latimer N, Julious S, Cross E, Alshreef A, Harrison M, Bradley E, Witts H, Chater T. Self-managed, computerised speech and language therapy for patients with chronic aphasia post-stroke compared with usual care or attention control (Big CACTUS): a multicentre, single-blinded, randomised controlled trial. Lancet Neurol. 2019 Sep;18(9):821-833. doi: 10.1016/S1474-4422(19)30192-9.

  PMID: 31397288 BACKGROUND

• Redgrave J, Day D, Leung H, Laud PJ, Ali A, Lindert R, Majid A. Safety and tolerability of Transcutaneous Vagus Nerve stimulation in humans; a systematic review. Brain Stimul. 2018 Nov-Dec;11(6):1225-1238. doi: 10.1016/j.brs.2018.08.010. Epub 2018 Aug 23.

  PMID: 30217648 BACKGROUND

MeSH Terms

Conditions

Aphasia; Stroke

Interventions

Language Therapy

Condition Hierarchy (Ancestors)

Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Officials

• Dr Ali Ali

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Prof. Arshad Majid

  University of Sheffield

  STUDY DIRECTOR

• Prof. Rebecca Palmer

  University of Sheffield

  STUDY DIRECTOR

Central Study Contacts

Dr Ali Ali

CONTACT

01142159114; ali.ali@sheffield.ac.uk

Miss Samantha Dorney

CONTACT

sldorney1@sheffield.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: April 25, 2024
• Primary Completion (Estimated): June 3, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

GB (1)