Primary Objective: - To gain insight on the underlying mechanisms of the variability of the response to ATN-DBS in patients with AED refractory epilepsySecondary Objective(s): - To gain insight in the neurophysiology of the anterior thalamic nucleus…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
This observational study aims at the registration of ATN signals in the
immediate postoperative stage.
We compare these parameters in groups with good response and patients with poor
response.
Note that these parameters are (up till now) not clinically significant end
points.
Secondary outcome
-
Background summary
Bilateral stimulation of the anterior thalamic nucleus (ATN-DBS) leads to
reduction of seizure frequency in patients who were refractory to medical
treatment. The treatment response however varies widely in the trial data,
reported by Fisher et al from a 100% response to even an increase in seizure
frequency. On average, patients had a decrease of 1/3 of their seizures.
The mechanism of action, but also the cause of the variability in the response
remains unclear. These may be related to electrophysiological factors, as
during the implantation of the DBS electrode some conspicuous bursts have been
found, however, the clinical significance is unclear. It is unknown however
whether these specific signals in the anterior thalamic nucleus are more
associated with seizures and whether the presence of some specific signal types
may predict a higher response rate to ATN-DBS.
On the other hand, it is unclear whether and when patients will experience side
effects of ATN-DBS.
In order to gain insight on the causes of a variable response to ATN-DBS, we
plan to register signals from the anterior thalamic nucleus in the acute
perioperative stage.
Study objective
Primary Objective:
- To gain insight on the underlying mechanisms of the variability of the
response to ATN-DBS in patients with AED refractory epilepsy
Secondary Objective(s):
- To gain insight in the neurophysiology of the anterior thalamic nucleus
- To gain insight on the why and how of the occurrence of side effects in
ATN-DBS
Study design
The study design is observational in character. Patients are recruited from the
patients who qualify on clinical grounds for treatment with ATN-DBS because of
refractory epilepsy. These patients are selected by a multidisciplinary team of
specialists (neurologists, neurophysiologists, neurosurgeons, a
neuroradiologist, and a neuropsychologist).
Patients receive their treatment (implantation of the DBS electrodes) in the
Maastricht University Medical Center.
Procedure:
Peroperative measurements (implantation occurs in general anesthesia):
Registration of neurophysiologic signals from the ATN
Measurements in the direct postoperative stage:
Registration of ATN signals in combination with regular surface
electroencephalogram (EEG) during 12 hours, electrical stimulation and
cognitive testing
Study burden and risks
Patients probably have no direct benefit from the current study, though there
are some minor risks.
The registration period of 12 hours with intracranial electrode has a small
risk of infection. In patients with Parkinson*s disease though, this procedure
has never led to any complications.
On the other hand, registration of the thalamic signals (which are registered
at several different locations along the tip of the electrode) may lead to a
better understanding of the thalamocortical signal pathways, and selective
stimulation of the point of highest coherence or aberrant signal may lead to
higher effectiveness of the ATN-DBS.
P. Debyelaan 25
Maastricht 6228WX
NL
P. Debyelaan 25
Maastricht 6228WX
NL
Listed location countries
Age
Inclusion criteria
Medically refractory epilepsy
No possibility for resective epilepsy surgery
Incapacitating epilepsy or seizures (no absolute minimal frequency)
Minimum age 18 years
Exclusion criteria
Underlying malignancies, whenever life expectancy is lower than 2 years
Co-medication with anti-inflammatory drugs or systemic diseases with inflammation are possible exclusion criteria, depending on severity and stability. Whenever there is a stable disease, with a reasonable chance of sustained stability, and stable medication, inclusion is possible. In other cases, patients will be excluded.
There also may be clinical grounds on which the specialist team may decide that a patient does or does not qualify for ATN-DBS treatment. The team will be more hesitant in case of (co-existent) psychogenic, non-epileptic attacks, or low IQ (below 70).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43468.068.13 |