Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403475
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-05-03
Brief Title:
Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Sheffield Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Transcutaneous Vagus Nerve Stimulation for Language Recovery After Stroke a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSLATES
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
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 andor 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None