The primary objective of this study is to evaluate differences in motor evoked potential (MEP) and TMS evoked potential (TEP) to paired pulse TMS between epilepsy patients and healthy controls. Secondary objectives are 1) To evaluate differences in…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters are the characteristics of the MEP (resting motor
threshold (rMT) and long intracortical inhibition (LICI)) and TEP (amplitude
and latency of peaks).
Secondary outcome
Secondary study parameters include additional signal analysis methods applied
on the MEP and TEP. For example, wavelet analysis of early and late TEPs and
the spatio-temporal characteristics of the TEP.
Other study parameters which are documented include: age, gender, handedness,
seizure history, type of epilepsy; generalized or focal (if diagnosis epilepsy
is confirmed afterwards), EEG abnormalities (if applicable) and MRI
abnormalities (if applicable).
Background summary
Epilepsy is one of the most common neurological disorders. Due to an increased
cortical excitability of the brain of epilepsy patients, epileptic seizures can
occur. However, between the epileptic seizures, the brain may function
completely or almost normally. This results in the limited sensitivity of the
routine electroencephalogram (EEG); approximately 45% of the routine EEGs
recorded in epilepsy patients do not show any epileptiform abnormalities. This
makes that the diagnostic process in epilepsy is often time-consuming and
labour-intensive.
Transcranial magnetic stimulation (TMS) in combination with EEG makes it
possible to stimulate the brain by applying magnetic pulses, while
simultaneously measuring the response of the brain to the applied pulse. In
this way TMS provides the opportunity to assess cortical excitability.
The combination of paired pulse TMS-EEG makes it hopefully possible to diagnose
or rule out epilepsy faster and more reliable.
Study objective
The primary objective of this study is to evaluate differences in motor evoked
potential (MEP) and TMS evoked potential (TEP) to paired pulse TMS between
epilepsy patients and healthy controls.
Secondary objectives are
1) To evaluate differences in MEP and TEP to paired pulse TMS between
patients presenting with a first (epileptic) seizure who are diagnosed with
epilepsy afterwards and those who are not
2) To evaluate reproducibility of the MEP and TEP to paired pulse TMS
3) To explore (additional) signal analysis techniques for characterising the
MEP and TEP to paired pulse TMS
4) To collect TMS-EMG and TMS-EEG data of healthy subjects to be used as
control data for other epilepsy studies
Study design
Interventional study at the Clinical Neurophysiology and Neurology departments
of the Medisch Spectrum Twente.
Intervention
The first seizure patients will undergo one paired pulse TMS session (selection
of 30 patients will undergo two TMS sessions) and thirty healthy controls will
undergo two paired pulse TMS sessions, with one week in between. Furthermore,
ten healthy controls will undergo one single pulse TMS session.
Single and paired pulse TMS are non-invasive, safe and painless techniques.
Study burden and risks
Applying the EEG cap and EMG electrodes takes ~15 minutes, locating the motor
hot spot and determining the rMT ~10 minutes for each side, and the TMS session
~45 minutes. A total of 600 paired pulses and ~100 single pulses are applied.
During the TMS session subjects will be seated in a comfortable chair. During
the single pulse TMS session in ten healthy controls a total of 600 single
pulses are applied.
The EEG and EMG measurements, and listening to the noise sounds, will only
produce minor discomfort and do not have associated risks. Single and paired
pulse TMS is generally well tolerated and considered to be non-invasive, safe,
and painless.
Possible side-effects and risks include: hearing problems, syncope, headache,
local pain, discomfort or seizures.
Overall, the risk of this study is low.
The subjects will have no benefit from participating in this study.
Drienerlolaan 5
Enschede 7522 NB
NL
Drienerlolaan 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
1) Patients presenting with a first (epileptic) seizure
* Presentation of a first (epileptic) seizure
* Ability to understand and comply with the instructions for the TMS session
, 2) Healthy controls
* Ability to understand and comply with the instructions for the TMS session
Exclusion criteria
* Younger than 18 years
* Contra-indications of TMS (although not absolute): (possibility of)
pregnancy, metal objects in brain/skull, cochlear implant, deep brain
stimulator, history of spinal cord surgery, drains in the spinal cord or
ventricles, use of seizure threshold lowering or enhancing medication
* Follow-up impossible due to logistical reasons, In addition, healthy
subjects are excluded if they have a personal history of epilepsy or if they
have a lesion in the brain, be it vascular, traumatic, infectious or metabolic.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL49854.044.14 |
| OMON | NL-OMON20996 |