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Drie aspecten in transcraniele magnetische stimulatie: Geluidsmaskering, puls intensiteit en plaatsing van de spoel.


- candidate number9264
- NTR NumberNTR2821
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2011
- Secondary IDsP11-14 METC
- Public TitleDrie aspecten in transcraniele magnetische stimulatie: Geluidsmaskering, puls intensiteit en plaatsing van de spoel.
- Scientific TitleThree methodological aspects in TMS-EEG: Noise masking, pulse intensity and need for accurate coil positioning.
- ACRONYMTMS02
- hypothesisBefore we start with our research on assessing the diagnostic value of TMS-EEG in epilepsy, we perform this pilot study to investigate a number of methodological aspects. To be able to develop a sound protocol these aspects need to be explored in healthy subjects and in patients who already are diagnosed with epilepsy.
- Healt Condition(s) or Problem(s) studiedTranscranial magnetic stimulation (TMS), Epilepsy
- Inclusion criteria1. Age between 18 and 60;
2. Patients: Focal epilepsy.
- Exclusion criteria1. Hearing problems;
2. (Possible) pregnancy;
3. Metal objects in brain/skull;
4. Cochleair implant, implanted brain electrode or pacemaker;
5. Severe medical condition;
6. Take medications that lower the threshold for seizure;
7. Spinal surgery, drains in spinal cord or ventricles;
8. Use illegal drugs.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-mei-2011
- planned closingdate31-dec-2011
- Target number of participants21
- InterventionsTMS (transcranial magnetic stimulation). The TMS equipment has a maximum output of 1.5 Tesla. The puls duration is 400 microsec. Pulses are given with a frequency of ~0.25 Hz (single pulse TMS).

First, the hot spot and motor threshold of the abductor digiti minimi muscle (ADM) are determined on both sides. In healthy subjects, we stimulate the hot spot in the left hemisphere, while applying 8 different types of noise masking. After that, we stimulate at 7 different intensities and at 8 locations surrounding the hot spot.

In patients, we stimulate 6 different brain areas (hot spot left/right, Brodmann area 19 left/right, epileptic focus ipsilateral/contralateral). If they show abnormal responses, patients return for a second day of measurements. On that day we stimulate at 7 different intensities and at 8 locations surrounding a specific target.
- Primary outcomeOur main endpoints are the presence and characteristics of the auditory evoked potential, the TMS-MEP and TMS-EEG response.
1. Auditory evoked potential:
A. Amplitude (microV);
B. Latency (msec).
2. MEP:
A. Amplitude (mV);
B. Latency (msec);
C. Motor Threshold (Tesla).
3. TMS-EEG response:
A. Amplitude of peaks (microV);
B. Latencies of peaks (msec).
- Secondary outcomeTMS-EEG response: Additional signal analysis methods, including wavelet analysis of early and late TMS-EEG responses and the spatiotemporal characteristics of the TMS-EEG response.

In the epilepsy patients, we will record the number of epileptic abnormalities in the EEG before and after the TMS experiment.
- TimepointsHealthy subjects: 1 half day of TMS measurements;
Epilepsy patients: 1 half day of TMS measurements. If they show abnormal responses, there will be a second half day of TMS measurements.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc Esther Braack, ter
- CONTACT for SCIENTIFIC QUERIESProf. dr. ir. M.J.A.M. Putten, van
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
PIDON (Pieken in de Delta Oost Nederland)
- PublicationsN/A
- Brief summaryRationale:
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 and epilepsy patients.

Objective:
The main objective is to investigate 3 methodological issues for TMS-EEG.

Study design:
Interventional study.

Study population:
1. 11 Healthy volunteers, age between 18 and 60 years, who do not take pro-epileptogenic medication or drugs and without a personal history of epilepsy;
2. 10 Epilepsy patients who have focal epilepsy.

Intervention:
Healthy subjects: three single-pulse TMS sessions during one day. Epilepsy patients: one single-pulse TMS session on the first day and three single-pulse TMS sessions on a second day.

Main study parameters/endpoints:
Auditory evoked potential (amplitude), motor threshold (%), TMS-MEP response (amplitude, latency), TMS-EEG response (amplitude, latency, frequency content).
- Main changes (audit trail)
- RECORD24-mrt-2011 - 4-jun-2011


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