|- candidate number||8152|
|- NTR Number||NTR2373|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||16-jun-2010|
|- Secondary IDs||P10-24 METC Medisch Spectrum Twente|
|- Public Title||TMS response in healthy subjects.|
|- Scientific Title||Single pulse TMS: variability and reproducibility of MEP and EEG responses in healthy subjects.|
|- hypothesis||Before we focus our research on TMS-EEG experiments in epilepsy patients, we first aim to learn more about the characteristics and intra-subject variability of the TMS-EEG and MEP response in healthy subjects.
In addition, we will evaluate if TMS-EEG and MEP responses show a circadian rhythm. Although this was explored in a previous study [Koski 2005], no definite conclusions were drawn, possibly due to significant variability in the measurements due to inaccurate (re-)positioning of the magnetic coil. We expect to confirm or reject the presence of a circadian rhythm of the motor threshold. Clearly, the presence or absence of a circadian rhythm is relevant for subsequent measurements in patients, as this may interfere with variations due to epilepsy.
|- Healt Condition(s) or Problem(s) studied||Transcranial magnetic stimulation (TMS), Epilepsy, Diagnosis|
|- Inclusion criteria||1. Age between 18 and 60;|
|- Exclusion criteria||1. Personal history of epilepsy;|
2. Lesion in the brain;
3. Hearing problems;
4. (Possible) pregnancy;
5. Metal objects in brain/skull;
6. Cochleair implant, implanted brain electrode or pacemaker;
7. Severe medical condition;
8. Take medications that lower the threshold for seizures
spinal surgery, drains in spinal cord or ventricles;
9. Use illegal drugs.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||20-jul-2010|
|- planned closingdate||30-sep-2010|
|- Target number of participants||20|
|- Interventions||Our Transcranial Magnetic Stimulation equipment has a maximum output of 1,5 Tesla. Pulse duration is 400 microsec. 50 single TMS pulses will be given to 6 different brain areas (3 on each hemisphere) while the EMG and EEG are recorded.
First, the hot spot and motor threshold of the right extensor digiti minimi (EDM) will be determined. Then, we stimulate the 3 brain areas on the left hemisphere with 110% of motor threshold. Measurements are then repeated for the right hemisphere. Pulses will be given with a frequency of ~0.25 Hz (single pulse TMS).
|- Primary outcome||The primary objective of this study is to evaluate if there exists a circadian variability of the MEP and EEG response to single pulse TMS in healthy subjects. |
|- Secondary outcome||1. Investigate the accuracy of coil placement and the overall reproducibility of the MEP and EEG measurements performed with our equipment;|
2. Explore additional signal analysis techniques for characterizing the EEG response;
3. Evaluate the TMS-EEG protocol for future studies in epilepsy patients;
4. Collect TMS-MEP and TMS-EEG data in healthy subjects to use as control data for future studies in epilepsy patients.
|- Timepoints||Subjects will receive an MRI of the head prior to the TMS experiment. During the day of the experiment, the subject will undergo 5 TMS sessions during the day (8:00 AM - 10:30AM - 13:00 PM - 15:30PM - 18:00 PM). Five subjects will return 1 week after the day of the experiments for an additional TMS session.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc Esther Braack, ter|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. ir. M.J.A.M. Putten, van|
|- Sponsor/Initiator ||Medisch Spectrum Twente, University of Twente|
(Source(s) of Monetary or Material Support)
|PIDON (Pieken in de Delta Oost Nederland)|
|- Brief summary||Rationale: |
The diagnostic process in epilepsy is often time-consuming due to the limited sensitivity and the nature of standard EEG recordings. TMS-EEG is a candidate tool to significantly improve the diagnostic efficiency in epilepsy. In this study, we will perform initial measurements in healthy volunteers to evaluate the normal variation and the presence of a circadian rhythm in TMS-EEG responses.
The main objective is to explore and quantify the variability and reproducibility of MEP and EEG responses after single pulse TMS in healthy subjects.
20 Healthy, right-handed volunteers, age between 18 and 60 years, who do not take pro-epileptogenic medication or drugs and without a personal history of epilepsy.
Five single pulse TMS sessions during 1 day.
Main study parameters/endpoints:
Variability and reproducibility of MEP (Motor Evoked Potential: amplitude, latency) and EEG response (electroencephalography response: amplitude, latency, frequency content) for 3 different brain areas.
|- Main changes (audit trail)|
|- RECORD||16-jun-2010 - 20-apr-2011|