|- candidate number||12389|
|- NTR Number||NTR3442|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-mei-2012|
|- Secondary IDs|| |
|- Public Title||The effects of cervical spinal cord stimulation on the cerebral blood flow.|
|- Scientific Title||The effects of cervical spinal cord stimulation on the cerebral blood flow.|
|- hypothesis||Electrical stimulation of the sympathetic pathways by cervical spinal cord stimulation increases cerebral blood flow.|
|- Healt Condition(s) or Problem(s) studied||Spinal cord stimulation, Cerebral blood flow, Autoregulation|
|- Inclusion criteria||1. Patients with SCS, stimulating the cervical myelum;|
2. Age > 18 years;
3. Informed consent signed by patient.
|- Exclusion criteria||1. 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 received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-jul-2012|
|- planned closingdate||1-sep-2012|
|- Target number of participants||5|
|- Interventions||The 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 outcome||Cerebral blood flow velocities as measured with TCD combined with cerebral oxygenation determined by NIRS.|
|- Secondary outcome||1. Body surface temperature measured by thermography;|
2. Blood pressure;
3. Heart rate;
4. End tidal CO2;
5. Registration of adverse events.
|- Timepoints||May-June: METC UMCG approval;|
July: Start experimental measurements;
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| L.P. Govindarajan|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.W.J. Elting|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Publications||1.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 summary||Spinal 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)|
|- RECORD||17-mei-2012 - 3-jun-2012|