Cervically applied TENS (transcutaneous electrical neurostimulation) might improve cerebral perfusion and therefore reduce the effectd of cerebral vasospasm afte SAH (subarachnoid haemorrhage).
Bron
Aandoening
Subarachnoid haemorrhage (SAH), cerebral vasospasm, transcutaneous electrical neurostimulation (TENS), sympathetic nervous system.
Subarachnoidale bloeding (SAB), cerebrale vaatspasmen, transcutane electrische neurostimulatie (TENS), sympathisch zenuwstelsel.
Ondersteuning
Departments of neurosurgery, clinical neurophysiology, neurology and epidemiology
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
Cerebral bloodflowvelocities as measured with TCD.
Achtergrond van het onderzoek
Rationale:
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.
Doel van het onderzoek
Cervically applied TENS (transcutaneous electrical neurostimulation) might improve cerebral perfusion and therefore reduce the effectd of cerebral vasospasm afte SAH (subarachnoid haemorrhage).
Onderzoeksopzet
1. Day 0;
2. Dat 3 or 4;
3. Day 7.
Onderzoeksproduct en/of interventie
The 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.
Publiek
M. Laan, ter
Groningen 9700 RB
The Netherlands
+31 (0)50 3612440
m.ter.laan@nchir.umcg.nl
Wetenschappelijk
M. Laan, ter
Groningen 9700 RB
The Netherlands
+31 (0)50 3612440
m.ter.laan@nchir.umcg.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL2232 |
NTR-old | NTR2358 |
Ander register | ABR / METc UMCG : 32001 / 2010.123 ; |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |