Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 195 for:    Hemorrhage AND SAH

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02482883
Recruitment Status : Active, not recruiting
First Posted : June 26, 2015
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Poitiers University Hospital

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.


Condition or disease Intervention/treatment Phase
Subarachnoid Haemorrhage (SAH) Device: Transcutaneous Electrical Nerve Stimulation (TENS) Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : September 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms Bleeding

Arm Intervention/treatment
Active Comparator: active Transcutaneous Electrical Nerve Stimulation
Arm A, treated by active stimulation of the trigeminovascular system after placement of the TENS device.
Device: 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.

Sham Comparator: 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.
Device: 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.




Primary Outcome Measures :
  1. Development of cerebral Infarction on MRI (FLAIR sequence) [ Time Frame: At 3 months ]

Secondary Outcome Measures :
  1. Functional disability (modified Rankin scale and GOS). [ Time Frame: At 6 months ]
  2. Evaluation of quality of life (EQ-5D) [ Time Frame: At 6 months ]
  3. An anomaly of perfusion detected on perfusion CT-scan [ Time Frame: At day 6 ]
  4. Evaluation of MTT (Mean Transit Time) [ Time Frame: At day 6 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02482883


Locations
Layout table for location information
France
BATAILLE
Poitiers, France, 86021
Sponsors and Collaborators
Poitiers University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Benoit BATAILLE Poitiers University Hospital

Layout table for additonal information
Responsible Party: Poitiers University Hospital
ClinicalTrials.gov Identifier: NCT02482883     History of Changes
Other Study ID Numbers: TRIVASOSTIM
First Posted: June 26, 2015    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Subarachnoid Hemorrhage
Hemorrhage
Intracranial Hemorrhages
Vasospasm, Intracranial
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases