To find out if cervical TENS affects cerebral bloodflow as measured with transcranial doppler sonography in healthy subjects, and to find a dose-response relation for this effect. To find out if cervical TENS can suppress sympathetic tone as…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cerebral bloodflow as measured by transcranial doppler sonography.
Secondary outcome
Bloodpressure and pulse.
Registration of adverse events.
Background summary
Transcutaneous electrical neurostimulation (TENS) has been shown to reduce
sympathetic tone. TENS is to be considered the cutaneous analogue of Spinal
Cord Stimulation (SCS), which has been proven to improve coronary, cerebral and
peripheral blood circulation. In this line of thought TENS might be a useful
adjunct in treatment of vasospasm in Subarachnoid Hemorrhage (SAH) patients.
Before using TENS in SAH patients, a dose-response relation and safety analysis
has to be done.
Study objective
To find out if cervical TENS affects cerebral bloodflow as measured with
transcranial doppler sonography in healthy subjects, and to find a
dose-response relation for this effect.
To find out if cervical TENS can suppress sympathetic tone as measured with
transcranial doppler sonography in healthy hyperventilating subjects.
Study design
Controlled (subject is own control), non-randomized trail. Phase I-II study.
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. Hyperventilation can cause
dizziness and peripheral paresthesia. No adverse effects are expected from
increased cerebral bloodflow.
There are no benefits for the participating subjects.
Hanzeplein 1
9700 RB Groningen
Nederland
Hanzeplein 1
9700 RB Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Age 25-65 years
Informed consent signed by patient
Exclusion criteria
History of vascular disease.
History of any neurological disease (including neuropathy).
History of cervical or skull-base surgery.
Presence of any electronic implant.
Use of (para)sympatholytic or (para)sympathicomimetic medication.
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 | NL19420.042.08 |