Subarachnoid Haemorrhage (SAH)TRIVASOSTIMNCT02482883
Evaluation of Transcutaneous Trigeminal Nerve Stimulation for Prevention of Cerebral Vasospasm After Subarachnoid Haemorrhage
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Subarachnoid Haemorrhage (SAH), run by Poitiers University Hospital at 1 site in France.
Trial summary
Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly related to the initial damage induced by SAH and delayed… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Subarachnoid Haemorrhage (SAH)
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2015to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 75 years.
- Admission within 48 h after onset of SAH.
- Ruptured cerebral aneurysm confirmed on CT angiography or cerebral angiography.
- Patient classified as grade I-IV according to the WFNS (World Federation of Neurological Surgeons) classification.
- Covered by French national health insurance.
- Absence of active cancer.
Who cannot join
- Age < 18 years and > 75 years.
- Absence of signature of the informed consent form by the patient or a close relative.
- Person subject to reinforced protection Clinical state on admission classified as WFNS grade V (excessively high mortality rate).
- Intracerebral or intraventricular haemorrhage without subarachnoid involvement.
- Major complication during the aneurysm exclusion procedure.
- SAH with no demonstrated aneurysm.
- Presence of non-ruptured cerebral aneurysm.
- Contraindication to placement of a transcutaneous device.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy of Transcutaneous Trigeminal Nerve Stimulation for Prevention of Cerebral Vasospasm and Its Consequences After Subarachnoid Haemorrhage Due to Ruptured Aneurysm: a Multicentre, Randomized, Double-blind Study
Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly related to the initial damage induced by SAH and delayed cerebral ischaemia (DCI), which is generally secondary to cerebral vasospasm.
Cerebral vasospasm is one of the main factors of poor prognosis after SAH, as it is associated with a 1.5- to 3-fold increase in the mortality rate during the 2 weeks following SAH in these patients.
Read more
Despite a significant improvement in the time to management of this disease and the fact that the ruptured aneurysm is very often rapidly excluded by surgical or endovascular intervention, patients who survive the initial SAH remain at risk of severe complications over the following 2 weeks.
Vascular stenosis of an arterial segment, called cerebral vasospasm, is observed in more than 70 to 95% of cases on digital subtraction angiography between the 7th and 14th days after ruptured aneurysm. This angiographic vasospasm can be responsible for cerebral infarction in 52 to 81% of cases.
Despite 50 years of research, no clearly demonstrated effective treatment for vasospasm is currently available.
This is a multicentre, randomized, comparative study, including 364 patients during the acute phase following ruptured aneurysm, in whom management is very often limited to control of complications, after exclusion of the aneurysm.
The objective of this study is to validate the efficacy of transcutaneous trigeminal nerve stimulation for the prevention of vasospasm and limitation of the consequences of delayed cerebral ischaemia after SAH.
This is an innovative project, as it comprises intervention in these patients prior to the development of complications and could limit the development of these complications. The prevention tool, based on external facial nerve stimulation, is a totally innovative, reversible and noninvasive technique. Use of nerve stimulation in this indication has never been previously reported and could radically modify the intensive care management of this disease over the years to come.
- Conditions
- Subarachnoid Haemorrhage (SAH)
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical Nerve Stimulation (TENS)Device
All patients will undergo placement of a facial transcutaneous electrical nervous stimulation (TENS) device, but device activation will be randomized [active stimulation vs non-active (placebo) stimulation], for an initial period of 10 days.
| Study group | Role | What they receive |
|---|---|---|
| active Transcutaneous Electrical Nerve Stimulation | Active comparator | Arm A, treated by active stimulation of the trigeminovascular system after placement of the TENS device. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
| sham Transcutaneous Electrical Nerve Stimulation | Sham comparator | Arm B, treated by non-active (sham) stimulation after placement of the TENS device. This absence of stimulation corresponds to the standard of care currently received by patients hospitalized for SAH due to ruptured aneurysm. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of cerebral Infarction on MRI (FLAIR sequence)
Measured: At 3 months
Secondary outcomes (4)
Functional disability (modified Rankin scale and GOS).
Measured: At 6 months
Evaluation of quality of life (EQ-5D)
Measured: At 6 months
An anomaly of perfusion detected on perfusion CT-scan
Measured: At day 6
Evaluation of MTT (Mean Transit Time)
Measured: At day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid Haemorrhage (SAH)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit BATAILLE, Principal investigator, Poitiers University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02482883
- Sponsor's protocol ID
- TRIVASOSTIM
- Acronym
- TRIVASOSTIM
- Status last verified
- Nov 2019
- First submitted
- 18 Jun 2015
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Transcutaneous Trigeminal Nerve Stimulation for Prevention of Cerebral Vasospasm and Its Consequences After Subarachnoid Haemorrhage Due to Ruptured Aneurysm: a Multicentre, Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT02482883
- Acronym / sponsor ID
- TRIVASOSTIM / TRIVASOSTIM
- Conditions
- Subarachnoid Haemorrhage (SAH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 26 Jun 2015 (estimated)
- 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.
Subarachnoid haemorrhage (SAH) secondary to ruptured aneurysm represents 5 to 15% of all cases of stroke. The mortality rate of SAH is 40% and the risk of serious neurological sequelae among survivors is 10 to 20%.The causes of morbidity and mortality are mainly related to the initial damage induced by SAH and delayed cerebral ischaemia (DCI), which is generally secondary to cerebral vasospasm.
Cerebral vasospasm is one of the main factors of poor prognosis after SAH, as it is associated with a 1.5- to 3-fold increase in the mortality rate during the 2 weeks following SAH in these patients.
Despite a significant improvement in the time to management of this disease and the fact that the ruptured aneurysm is very often rapidly excluded by surgical or endovascular intervention, patients who survive the initial SAH remain at risk of severe complications over the following 2 weeks.
Vascular stenosis of an arterial segment, called cerebral vasospasm, is observed in more than 70 to 95% of cases on digital subtraction angiography between the 7th and 14th days after ruptured aneurysm. This angiographic vasospasm can be responsible for cerebral infarction in 52 to 81% of cases.
Despite 50 years of research, no clearly demonstrated effective treatment for vasospasm is currently available.
This is a multicentre, randomized, comparative study, including 364 patients during the acute phase following ruptured aneurysm, in whom management is very often limited to control of complications, after exclusion of the aneurysm.
The objective of this study is to validate the efficacy of transcutaneous trigeminal nerve stimulation for the prevention of vasospasm and limitation of the consequences of delayed cerebral ischaemia after SAH.
This is an innovative project, as it comprises intervention in these patients prior to the development of complications and could limit the development of these complications. The prevention tool, based on external facial nerve stimulation, is a totally innovative, reversible and noninvasive technique. Use of nerve stimulation in this indication has never been previously reported and could radically modify the intensive care management of this disease over the years to come.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active Transcutaneous Electrical Nerve Stimulation | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Arm A, treated by active stimulation of the trigeminovascular system after placement of the TENS device. |
| sham Transcutaneous Electrical Nerve Stimulation | Sham comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS)Arm B, treated by non-active (sham) stimulation after placement of the TENS device. This absence of stimulation corresponds to the standard of care currently received by patients hospitalized for SAH due to ruptured aneurysm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years and ≤ 75 years.
- Admission within 48 h after onset of SAH.
- Ruptured cerebral aneurysm confirmed on CT angiography or cerebral angiography.
- Patient classified as grade I-IV according to the WFNS (World Federation of Neurological Surgeons) classification.
- Covered by French national health insurance.
Key exclusion criteria (8 listed)
- Age < 18 years and > 75 years.
- Absence of signature of the informed consent form by the patient or a close relative.
- Person subject to reinforced protection Clinical state on admission classified as WFNS grade V (excessively high mortality rate).
- Intracerebral or intraventricular haemorrhage without subarachnoid involvement.
- Major complication during the aneurysm exclusion procedure.
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 Electrical Nerve Stimulation (TENS)All patients will undergo placement of a facial transcutaneous electrical nervous stimulation (TENS) device, but device activation will be randomized [active stimulation vs non-active (placebo) stimulation], for an initial period of 10 days. | Device | active Transcutaneous Electrical Nerve Stimulation, sham Transcutaneous Electrical Nerve Stimulation |
Primary outcome
Development of cerebral Infarction on MRI (FLAIR sequence)
Time frame: At 3 months
4 secondary outcomes
Functional disability (modified Rankin scale and GOS).
Time frame: At 6 months
Evaluation of quality of life (EQ-5D)
Time frame: At 6 months
An anomaly of perfusion detected on perfusion CT-scan
Time frame: At day 6
Evaluation of MTT (Mean Transit Time)
Time frame: At day 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
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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. This study is not recruiting at the moment.
Benoit BATAILLE principal investigator
Poitiers University Hospital
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 Electrical Nerve Stimulation (TENS) in people with Subarachnoid Haemorrhage (SAH), run by Poitiers University Hospital at 1 site in France.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 8 Nov 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of cerebral Infarction on MRI (FLAIR sequence) (time frame: At 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2019.