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The effect of cervical transcutaneous electrical neurostimulation on cerebral blood flow and infarction as a result of vasospasm after subarachnoid haemorrhage.


- candidate number8121
- NTR NumberNTR2358
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-jun-2010
- Secondary IDs32001 / 2010.123 ; ABR / METc UMCG
- Public TitleThe effect of cervical transcutaneous electrical neurostimulation on cerebral blood flow and infarction as a result of vasospasm after subarachnoid haemorrhage.
- Scientific TitleThe effect of cervical transcutaneous electrical neurostimulation on cerebral blood flow velocities, cerebral vasospasm and ischemic deficit in secondary cerebral vasospasm after subarachnoid haemorrhage.
- ACRONYM
- hypothesisCervically applied TENS (transcutaneous electrical neurostimulation) might improve cerebral perfusion and therefore reduce the effectd of cerebral vasospasm afte SAH (subarachnoid haemorrhage).
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. Confirmed aneurysmatic subarachnoid hemorrhage;
2. Cerebral vasospasm demonstrated by TCD, defined as a MCA/ICA ratio >3;
3. Aneurysm is treated with a surgical or endovascular procedure;
4. Age > 18 years;
5. Treatment can be started promptly;
6. Informed consent signed by patient or family.
- Exclusion criteria1. History of cervical spine or skull-base surgery;
2. Known adverse reaction to TENS-pads;
3. The presence of any implanted electronic device (including pacemakers);
4. Pre-existing disease that can obscure follow-up;
5. Unacceptable interference with cardiographic registration (in case intensive care is necessary);
6. Insuficient temporal bony windows.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2010
- planned closingdate1-aug-2011
- Target number of participants10
- InterventionsThe first part of the study concerns the finding of an optimal frequency. When the stimulation will be started, optimal parameters will be sought. The pulse-width will be 200ms in all patients. The current used for stimulation will be determined as 90% of the highest tolerated current (max 80mA), or 90% of the current that evokes a motor-response (whichever comes first). The stimulation frequency will be 20, 50, 100 and 120 Hz consecutively in the first session (10 minutes each, followed by a recovery period of 10 minutes). The frequency that shows most effect on the measured blood flow velocities in the middle cerebral artery by TCD, or most effect on the NIRS signal, will be used in the following stimulation. If a superior frequency cannot be determined, 100Hz will be chosen.
The second part of the study concerns changes in study parameters during a 7 day period of stimulation using the frequency determined by the first part of the study. Stimulation will take place from day 1 until day 3 and from day 5 until day 7, 24 hours a day (if tolerated). The fourth day stimulation will be discontinued, in order to to detect changes when TENS is stopped and started again the next day. During this period the patient will receive our regular care for subarachnoid hemorrhage patients consisting of daily neurological exams, nimodipine administration, triple H therapy (hypertension, hypervolemia and hemodilution), 2 weekly TCD measurements and IC unit admission or CT scanning if necessary. Added to this will be three sessions of registration, one at day 1 (start of treatment including finding of optimal current and frequency), one at day 3 (just before stimulation will be discontinued), one at day 4 (just before stimulation will be started again) and one at the end of stimulation (day 7). Registration will consist of continuous registration during 30 minutes of TCD signal at the middle cerebral artery on both sides, NIRS on both sides, end tidal carbondioxide, bloodpressure and pulse. After the period of stimulation a CT scan will be performed in order to measure any present infarction.
Patients will be seen in our outpatient clinic, six weeks after dismissal from the hospital, as a routine follow-up. A modified Rankin outcome score will be determined, deficits will be documented.
- Primary outcomeCerebral bloodflowvelocities as measured with TCD.
- Secondary outcome1. Cerebral oxygenation determined by NIRS;
2. Neurological examination, combined with CT image;
3. Bloodpressure and pulse;
4. Registration of adverse events.
- Timepoints1. Day 0;
2. Dat 3 or 4;
3. Day 7.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD M. Laan, ter
- CONTACT for SCIENTIFIC QUERIESMD M. Laan, ter
- Sponsor/Initiator University Medical Center Groningen (UMCG), department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryRationale:
Transcutaneous electrical neurostimulation (TENS) has shown to reduce sympathetic tone. TENS is to be considered the cutaneous analogue of Spinal Cord Stimulation (SCS), which has proven to improve coronary, cerebral and peripheral bloodcirculation. In this line of thought TENS might be a useful adjunct in treatment of vasospasm in Subarachnoid Hemorrhage (SAH) patients. We want to perform a study in patients with secondary cerebral vasospasm after SAH.

Objective:
To find out if patients with secondary cerebral vasospasm after SAH can benefit from cervical TENS.

Intervention:
Cervical TENS applied at different frequencies. Main study parameters/endpoints: Cerebral ischemia as seen on computed tomography scans, cerebral bloodflowvelocities as measured by transcranial doppler sonography, cerebral oxygenation as measured by near-infrared spectroscopy and clinical outcome.
- Main changes (audit trail)
- RECORD5-jun-2010 - 11-jan-2011


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