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Sponsor study identifier
interventional
36
1 country
1
Study Start
April 25, 2024
Actual (reported)Primary Completion
June 3, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 25, 2024
Actual (reported)May 3, 2024
Actual (reported)May 7, 2024
Actual (reported)June 3, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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
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.
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.
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.
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF, United Kingdom
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.
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.
Dr Ali Ali
Sheffield Teaching Hospitals NHS Foundation Trust
Prof. Arshad Majid
University of Sheffield
Prof. Rebecca Palmer
University of Sheffield
First Submitted
May 3, 2024
First Posted
May 7, 2024
Study Start
April 25, 2024
Actual (reported)Primary Completion
June 3, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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Study Completion
January 1, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 8, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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