To find out if patients with secondary cerebral vasospasm after SAH can benefit from cervical TENS.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cerebral bloodflowvelocities as measured by transcranial doppler sonography
Secondary outcome
Cerebral ischemia as seen on computed tomography scans
Cerebral oxygenationas measured by near-infrared spectroscopy
Bloodpressure and pulse.
Clinical outcome.
Background summary
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 prospective longitudinal observational study in patients with
secondary cerebral vasospasm after SAH.
Study objective
To find out if patients with secondary cerebral vasospasm after SAH can benefit
from cervical TENS.
Study design
Pilot with prospective longitudinal observational design.
Intervention
Cervical TENS applied at different frequencies.
Study burden and risks
The only known risk of TENS is local cutaneous irritation. From clinical
studies with cervical SCS it is known that there are no adverse systemic
effects of cervical electrical neurostimulation. In a previous study we have
shown that TENS can be safely applied. Possible benefit could be decrease of
cerebral deficits.
Hanzeplein 1
9700 RB Groningen
NL
Hanzeplein 1
9700 RB Groningen
NL
Listed location countries
Age
Inclusion criteria
Confirmed aneurysmatic subarachnoid hemorrhage.
Cerebral vasospasm demonstrated by TCD, defined as a MCA/ICA ratio >3
Aneurysm is treated with a surgical or endovascular procedure.
Age > 18 years.
Treatment can be started promptly.
Informed consent signed by patient or family.
Exclusion criteria
History of cervical spine or skull-base surgery.
Known adverse reaction to TENS-pads.
The presence of any implanted electronic device (including pacemakers).
Pre-existing disease that can obscure follow-up.
Unacceptable interference with cardiographic registration (in case intensive care is necessary).
Insuficient temporal bony windows
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL32001.042.10 |