Investigating the Tolerability and Feasibility of tVNS Following aSAH
tVNS in aSAH
1 other identifier
interventional
30
1 country
1
Brief Summary
After a subarachnoid haemorrhage, complications are common and increase the overall rate of disability and death from the condition. Despite some advances in preventing, detecting and treating these complications, the rates of complications and associated risks remain high. Further research into ways to reduce complications of subarachnoid haemorrhage. Transcutaneous vagus nerve stimulation (tVNS) is a technique where a small handheld device is attached to an earpiece which stimulates the nerves to the ear. This is given for short periods and may help improve blood flow and reduce inflammation in the brain. The intervention has been safely used and licensed in seizures, headache and severe depression. This study will look to see if it is feasible and tolerable to have tVNS twice daily for 5 days after subarachnoid haemorrhage, and whether it can help reduce the risk of complications from subarachnoid haemorrhage. The participant will be randomly allocated to receive either tVNS or a dummy intervention, known as sham. The researchers will collect some personal and clinical details such as diagnosis, medications, age, blood test results, as well as some details about the subarachnoid haemorrhage. The researchers will also complete brief questionnaires with the participant to assess symptoms. They will take measurements of heart rate, pupil response, and brain activity using a cap. The participant will then be randomly allocated to either receive the tVNS or sham intervention. Next, the research team will apply the earpiece to their ear twice a day for 45 minutes, for a total of 5 days. At the end of the 5-day study period, the intervention will be complete. The researchers will arrange a follow-up meeting on discharge and at 6 weeks, to assess the participants symptoms and recovery. Previous studies have shown that tVNS is safe and well tolerated, including a recent review of tVNS studies which evaluated the side effects experienced by 1322 patients receiving tVNS. The main side effects include localised tingling/numbness/pain/redness around the ear (17%), headaches (3%), dizziness (1%), facial droop (1%), nausea (1%), nasal discharge (2%). Rarely, palpitations or a slow heart rate may occur. They will continue to receive full medical treatment and observation alongside the study. They are free to withdraw from this study if they find it too demanding on top of their other activities.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2024
CompletedStudy Start
First participant enrolled
April 17, 2024
CompletedFirst Posted
Study publicly available on registry
April 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
March 20, 2026
February 1, 2026
2.1 years
March 25, 2024
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Monitor tolerability for tVNS
Symptom severity scores of mild or moderate in less than 1/3 of participants able to report symptoms
4 weeks
Assess study feasibility
recruit \>1 patient per month of recruitment, and \>80% of recruited patients completing primary outcome measures
24 months
Secondary Outcomes (12)
Monitor safety criteria for tVNS
4 weeks
Rates of delayed cerebral ischaemia (DCI)
4 weeks
Inpatient mortality
4 weeks
Length of inpatient stay
From the date of admission to the date of discharge from hospital up to 100 months
Rates of inpatient complications
From the date of admission to the date of discharge from hospital up to 100 months
- +7 more secondary outcomes
Study Arms (2)
Stimulation
EXPERIMENTALThe intervention will take place for 45 minutes twice a day for 5 days after securing the aneurysm
Sham
SHAM COMPARATORThe placebo group will receive the same intervention, but the device will be in 'sham' mode (i.e. attached to the earlobe).
Interventions
The active intervention will be compared to sham tVNS where the vagal nerve stimulator will be attached to the earlobe instead of the tragus, in keeping with evidence that this does not cause vagus nerve stimulation and is in line with sham methods used in other studies. We do not anticipate that patients will have the intervention long enough to become familiar with the common sensations associated with true tVNS intervention. At the end of the intervention period, participants will be asked if they thought they had received true of sham tVNS to understand the blinding ability of the sham.
* Pulse width - 25ms * Frequency - device default (20 or 25Hz) * Intensity - below pain threshold. * Frequency - 45 minutes twice daily. On the basis of similarity to other studies, practicalities on the ward and clinical scenario We have chosen a duration of 5 days based on the usual clinical pathway of inpatient management at the Royal Hallamshire Hospital, and have chosen to deliver the treatment twice daily to optimise the dose. This is a pilot study with feasibility outcomes and as such we will be exploring the feasibility of this treatment regimen. The Parasym Device will be applied to the left tragus (figure 1) as this is the most common site for tVNS delivery in neurological studies and is associated with few afferents to the heart.
Eligibility Criteria
You may qualify if:
- Age \>18
- Admitted to STH (Sheffield Teaching Hospital) neurosurgery department
- Confirmed aneurysmal SAH on vascular imaging
- Within 5 days of 'Securing' aneurysm (i.e., successfully coiled or surgically following rupture)
You may not qualify if:
- Current or prior use of a vagus nerve stimulation
- Symptomatic bradycardia or PPM insertion
- Complete heart block
- Implantation of any other electrical stimulator (e.g. DBS)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sheffield
Sheffield, South Yorkshire, S10 2HQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Ali Ali
Sheffield Teaching Hospitals NHS Foundation Trust
- STUDY DIRECTOR
Professor Arshad Majid
University of Sheffield
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2024
First Posted
April 19, 2024
Study Start
April 17, 2024
Primary Completion (Estimated)
May 30, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
March 20, 2026
Record last verified: 2026-02