Evaluation of Transcutaneous Trigeminal Nerve Stimulation for Prevention of Cerebral Vasospasm After Subarachnoid Haemorrhage

NCT ID: NCT02482883

Last Updated: 2019-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2019-05-31

Brief 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 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.

Conditions

Subarachnoid Haemorrhage (SAH)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

active Transcutaneous Electrical Nerve Stimulation

Arm A, treated by active stimulation of the trigeminovascular system after placement of the TENS device.

Group Type: ACTIVE_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: 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.

sham Transcutaneous Electrical Nerve Stimulation

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.

Group Type: SHAM_COMPARATOR

Transcutaneous Electrical Nerve Stimulation (TENS)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Poitiers University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benoit BATAILLE

Role: PRINCIPAL_INVESTIGATOR

Poitiers University Hospital

Locations

BATAILLE

Poitiers, , France

Countries

France

Other Identifiers

TRIVASOSTIM

Identifier Type: -

Identifier Source: org_study_id