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The effects of cervical spinal cord stimulation on the cerebral blood flow.


- candidate number12389
- NTR NumberNTR3442
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-mei-2012
- Secondary IDs 
- Public TitleThe effects of cervical spinal cord stimulation on the cerebral blood flow.
- Scientific TitleThe effects of cervical spinal cord stimulation on the cerebral blood flow.
- ACRONYM
- hypothesisElectrical stimulation of the sympathetic pathways by cervical spinal cord stimulation increases cerebral blood flow.
- Healt Condition(s) or Problem(s) studiedSpinal cord stimulation, Cerebral blood flow, Autoregulation
- Inclusion criteria1. Patients with SCS, stimulating the cervical myelum;
2. Age > 18 years;
3. Informed consent signed by patient.
- Exclusion criteria1. The presence of any other implanted electronic device (including pacemakers);
2. Pre-existing disease that can obscure follow-up or experimental set- up such as amputations;
3. Insufficient temporal bony windows;
4. The use of sympathicomimetic or sympathicolytic agents.
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2012
- planned closingdate1-sep-2012
- Target number of participants5
- InterventionsThe frequency and amplitude of the SCS device will be changed. The pulse-width will not be changed. The frequency will be of 130 Hz, pulse-width between 100 Hz- 130 Hz. The voltage of the stimulation will be 90% of maximum voltage that is tolerated or evoking a motor response. During the experiment the SCS will be switched on and off, with an alternating timespan of 5 mins.

The whole set-up consists for each subject of 1 measurement with a maximum duration of 2 hours. The subjects will be measured only once and do not have to come back.
- Primary outcomeCerebral blood flow velocities as measured with TCD combined with cerebral oxygenation determined by NIRS.
- Secondary outcome1. Body surface temperature measured by thermography;
2. Blood pressure;
3. Heart rate;
4. End tidal CO2;
5. Registration of adverse events.
- TimepointsMay-June: METC UMCG approval;
July: Start experimental measurements;
August-sep: Data-analyses.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES L.P. Govindarajan
- CONTACT for SCIENTIFIC QUERIESDr. J.W.J. Elting
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- Publications1.The influence of transcutaneous electrical neurostimulation (TENS) on human cerebral blood flow velocities.
2.The effect of cervical transcutaneous electrical neurostimulation on cerebral blood flow velocities, cerebral vasospasm and ischemic deficit in secondary cerebral vasospasm after subarachnoid haemorrhage.
- Brief summarySpinal Cord Stimulation has been used for many pathological conditions and has proven to improve coronary, cerebral and peripheral blood circulation. We would like to investigate the effect of spinal cord stimulation on the cerebral blood flow (CBF). We postulate that this effect is caused by the sympathetic pathway. Due to the electrical stimulation we suspect to suppress the sympathetic pathway, which in turn should cause the change in CBF.
- Main changes (audit trail)
- RECORD17-mei-2012 - 3-jun-2012


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