AphasiaTRANSLATENCT06403475
Transcutaneous Vagus Nerve Stimulation in Aphasia After Stroke
A study testing Transcutaneous Vagus Nerve Stimulation and Computer Based Speech and Language Therapy (Step by Step) in people with Aphasia and Chronic Stroke, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aphasia, Chronic Stroke
- What is being tested?
- Transcutaneous Vagus Nerve Stimulation and Computer Based Speech and Language Therapy (Step by Step)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Apr 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Miss Samantha Dorney contact
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
Dr Ali Ali, 01142159114, ali.ali@sheffield.ac.uk
Miss Samantha Dorney
About this study
Official title: Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke: a Pilot Study
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.
Read the detailed description
Aphasia is an acquired communication disorder, characterised by difficulties with the production and/or understanding of language. Stroke is the most common cause of aphasia which affects approximately 30% of stroke survivors. Many individuals are left with chronic deficits. Speech and Language Therapy (SLT) is the gold-standard treatment for aphasia but access to therapy is limited beyond the first few months of recovery. Individuals with chronic aphasia (>6 months) can benefit from SLT input. Computer-based SLT can lead to improvements in word-finding for people with aphasia, many years after stroke (Palmer et al., 2019). Improvements have not been found to translate to day-to-day conversation.
Vagus Nerve Stimulation (VNS) paired with upper limb rehabilitation has proved beneficial in chronic stroke. 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. The use of tVNS in chronic stroke is currently being explored, with promising findings when paired with upper limb rehabilitation exercises. To date, there are no published studies exploring the use of tVNS in chronic aphasia. Pairing tVNS with an SLT intervention may have the potential to promote language recovery in chronic stroke. An indication of study feasibility may support the development of a larger RCT to explore treatment efficacy.
This is a single centre, single blind, pilot randomised controlled trial. The primary aim is to explore the safety, tolerability and feasibility of self-directed computer-based SLT combined with tVNS, in individuals with chronic-stroke related aphasia. Secondary aims include exploring any indication of effect of the intervention on word-finding ability (trained words, generalisability to untrained words and conversation). Additionally, the study aims to explore potential mechanisms of action.
Participants will be asked to use the stimulation device alongside computer-based SLT, at home for 6 weeks. SLT training will include naming pictures of 30 personally relevant words, selected by the participant prior to the commencement of the intervention and uploaded onto the software. The SLT software (Step by Step) uses a self-guided errorless learning approach and will be completed on an ipad. The researcher will check-in with the participant each week to monitor any concerns, side effects and monitor engagement with the programme.
Potential participants will be recruited from Sheffield, using the NHS PHIND database. Accessible study invitations will be sent to potential participants. The Consent Support Tool will be used to ascertain the most appropriate way to provide study information. All participants will have capacity to consent to the study. Participants will be randomly allocated (SealedEnvelope Ltd) to an active or sham tVNS group, stratified according to language score. Participants will be blinded to group allocation.
The tVNS device will be applied to the ear (tragus or earlobe), depending on group allocation. The tVNS device (Nurosym/ Parasym II) is a UKCE marked device, indicated for off-label use in the current study. tVNS use is safe however it has been associated with mild and transitory side effects such as pain or irritation at the stimulation site, headache and nasopharyngitis (Redgrave et al 2018). Stimulation parameters are in line with previous studies:
- Pulse Width: 250µs
- Frequency: 25Hz
- Intensity: individual tolerability (below pain threshold)
- Duration: 45 minutes daily for 6 weeks
Language assessments will be taken at baseline, end of treatment (6 weeks) and at follow-up (12 weeks). To explore potential mechanisms, blood samples, heart rate variability (HRV) and pupillometry measures will be taken at baseline and end of treatment. The Functional near infrared spectroscopy (fNIRS; LUMO, Gowerlabs) will be used on a subset of participants to explore cortical activation in the frontal lobes in response to tVNS at baseline and end of treatment (6 weeks). Outcome measures will be undertaken by a trained member of the research team.
- Conditions
- Aphasia, Chronic Stroke
- Being tested
- Transcutaneous Vagus Nerve Stimulation, Sham Transcutaneous Vagus Nerve Stimulation, Computer Based Speech and Language Therapy (Step by Step)
- Keywords
- aphasia, vagus nerve stimulation, stroke, transcutaneous vagus nerve stimulation
- Medical subject headings
- Aphasia, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Vagus Nerve StimulationDevice
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.
Sham Transcutaneous Vagus Nerve StimulationDevice
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 (Step by Step)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sham Transcutaneous Vagus Nerve Stimulation; Behavioral: Computer Based Speech and Language Therapy (Step by Step) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
Measured: 24 months
Secondary outcomes (7)
Picture Naming (personally relevant)
The number of pictures that are accurately named at each time point, out of a maximum of 30. Pictures will be personally relevant and selected by the participant prior to the start of the intervention. These pictures will be trained during the computer-based SLT intervention. Naming will be assessed at baseline, end of treatment (6 weeks) and at follow-up (12 weeks) using the same picture set.
Measured: Week 0; Week 6; Week 12
The Comprehensive Aphasia Test (CAT): Naming Objects
The number of pictures that are accurately named at each time point, out of a maximum of 48. A standardized set of 24 pictures will be used from The Comprehensive Aphasia Test (CAT) Naming Objects subtest. This will assess the ability to name untrained words. This task will be completed at baseline, end of treatment (6 weeks) and at follow-up (12 weeks).
Measured: Week 0; Week 6; Week 12
Conversation: The number of trained words used in conversation
A 10 minute scripted conversation will be conducted for each participant, surrounding topics of personal relevance, to prompt the use of trained words in a conversational context. The number of times a word is used will be recorded
Measured: Week 0; Week 6; Week 12
Brain Derived Neurotrophic Factor (BDNF) (ng/ml)
Blood samples will be taken at baseline and end of treatment (6 weeks) to measure BDNF levels in serum
Measured: Week 0; Week 6
Inflammatory markers (pg/ml)
Blood samples will be taken at baseline and end of treatment (6 weeks) to measure inflammatory markers: IL-1B, IL-6, IL-10 and TNFa (pg/ml).
Measured: Week 0; Week 6
Heart Rate Variability (HRV)
Heart rate variability will be measured in 5 minute phases before, during and following electrical stimulation. The Standard deviation of the RR intervals (SDNN) will be recorded (ms).
Measured: Week 0; Week 6
Pupillary Reactivity
Pupillary response to light stimulus. Maximum and minimum diameters (mm)
Measured: Week 0; Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start25 Apr 2024
- Primary completion3 Jun 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Ali Ali, Principal investigator, Sheffield Teaching Hospitals NHS Foundation TrustProf. Arshad Majid, Study director, University of SheffieldProf. Rebecca Palmer, Study director, University of Sheffield
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403475
- Sponsor's protocol ID
- STH22935
- Acronym
- TRANSLATE
- Status last verified
- Dec 2025
- First submitted
- 3 May 2024
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31397288Redgrave 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.
PubMed 30217648
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke: a Pilot Study
- ClinicalTrials.gov ID
- NCT06403475
- Acronym / sponsor ID
- TRANSLATE / STH22935
- Conditions
- Aphasia, Chronic Stroke
- Keywords
- aphasia, vagus nerve stimulation, stroke, transcutaneous vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 25 Apr 2024 (actual)
- Primary completion
- 3 Jun 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aphasia is an acquired communication disorder, characterised by difficulties with the production and/or understanding of language. Stroke is the most common cause of aphasia which affects approximately 30% of stroke survivors. Many individuals are left with chronic deficits. Speech and Language Therapy (SLT) is the gold-standard treatment for aphasia but access to therapy is limited beyond the first few months of recovery. Individuals with chronic aphasia (>6 months) can benefit from SLT input. Computer-based SLT can lead to improvements in word-finding for people with aphasia, many years after stroke (Palmer et al., 2019). Improvements have not been found to translate to day-to-day conversation.
Vagus Nerve Stimulation (VNS) paired with upper limb rehabilitation has proved beneficial in chronic stroke. 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. The use of tVNS in chronic stroke is currently being explored, with promising findings when paired with upper limb rehabilitation exercises. To date, there are no published studies exploring the use of tVNS in chronic aphasia. Pairing tVNS with an SLT intervention may have the potential to promote language recovery in chronic stroke. An indication of study feasibility may support the development of a larger RCT to explore treatment efficacy.
This is a single centre, single blind, pilot randomised controlled trial. The primary aim is to explore the safety, tolerability and feasibility of self-directed computer-based SLT combined with tVNS, in individuals with chronic-stroke related aphasia. Secondary aims include exploring any indication of effect of the intervention on word-finding ability (trained words, generalisability to untrained words and conversation). Additionally, the study aims to explore potential mechanisms of action.
Participants will be asked to use the stimulation device alongside computer-based SLT, at home for 6 weeks. SLT training will include naming pictures of 30 personally relevant words, selected by the participant prior to the commencement of the intervention and uploaded onto the software. The SLT software (Step by Step) uses a self-guided errorless learning approach and will be completed on an ipad. The researcher will check-in with the participant each week to monitor any concerns, side effects and monitor engagement with the programme.
Potential participants will be recruited from Sheffield, using the NHS PHIND database. Accessible study invitations will be sent to potential participants. The Consent Support Tool will be used to ascertain the most appropriate way to provide study information. All participants will have capacity to consent to the study. Participants will be randomly allocated (SealedEnvelope Ltd) to an active or sham tVNS group, stratified according to language score. Participants will be blinded to group allocation.
The tVNS device will be applied to the ear (tragus or earlobe), depending on group allocation. The tVNS device (Nurosym/ Parasym II) is a UKCE marked device, indicated for off-label use in the current study. tVNS use is safe however it has been associated with mild and transitory side effects such as pain or irritation at the stimulation site, headache and nasopharyngitis (Redgrave et al 2018). Stimulation parameters are in line with previous studies:
- Pulse Width: 250µs
- Frequency: 25Hz
- Intensity: individual tolerability (below pain threshold)
- Duration: 45 minutes daily for 6 weeks
Language assessments will be taken at baseline, end of treatment (6 weeks) and at follow-up (12 weeks). To explore potential mechanisms, blood samples, heart rate variability (HRV) and pupillometry measures will be taken at baseline and end of treatment. The Functional near infrared spectroscopy (fNIRS; LUMO, Gowerlabs) will be used on a subset of participants to explore cortical activation in the frontal lobes in response to tVNS at baseline and end of treatment (6 weeks). Outcome measures will be undertaken by a trained member of the research team.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Vagus Nerve Stimulation | Experimental | Device: Transcutaneous Vagus Nerve Stimulation, Behavioral: Computer Based Speech and Language Therapy (Step by Step)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. |
| Sham Transcutaneous Vagus Nerve Stimulation | Sham comparator | Device: Sham Transcutaneous Vagus Nerve Stimulation, Behavioral: Computer Based Speech and Language Therapy (Step by Step)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Vagus Nerve StimulationTranscutaneous 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. | Device | Transcutaneous Vagus Nerve Stimulation |
| Sham Transcutaneous Vagus Nerve StimulationStimulation 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. | Device | Sham Transcutaneous Vagus Nerve Stimulation |
| Computer Based Speech and Language Therapy (Step by Step)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. | Behavioural | Sham Transcutaneous Vagus Nerve Stimulation, Transcutaneous Vagus Nerve Stimulation |
Primary outcome
Safety: The number of adverse events reported that are associated with tVNS
Time frame: 6 weeks
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.
Tolerability: The number and intensity of symptoms reported
Time frame: 6 weeks
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).
Percentage of participants completing the study intervention and outcome measures
Time frame: 24 months
>80% of recruited participants completing the intervention and primary outcome measures at 6 weeks
7 secondary outcomes
Picture Naming (personally relevant)
Time frame: Week 0; Week 6; Week 12
The Comprehensive Aphasia Test (CAT): Naming Objects
Time frame: Week 0; Week 6; Week 12
Conversation: The number of trained words used in conversation
Time frame: Week 0; Week 6; Week 12
Brain Derived Neurotrophic Factor (BDNF) (ng/ml)
Time frame: Week 0; Week 6
Inflammatory markers (pg/ml)
Time frame: Week 0; Week 6
Heart Rate Variability (HRV)
Time frame: Week 0; Week 6
Pupillary Reactivity
Time frame: Week 0; Week 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 31397288Palmer 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.
- Background: PubMed 30217648Redgrave 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Miss Samantha Dorney contact
Dr Ali Ali principal investigator
Sheffield Teaching Hospitals NHS Foundation Trust
Prof. Arshad Majid study director
University of Sheffield
Prof. Rebecca Palmer study director
University of Sheffield
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Vagus Nerve Stimulation and Computer Based Speech and Language Therapy (Step by Step) in people with Aphasia and Chronic Stroke, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Ali Ali (01142159114, ali.ali@sheffield.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: The number of adverse events reported that are associated with tVNS (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403475, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.