Determine the priming effect on the epileptic brain of tVNS, to make it more susceptible to treatment with Brivaracetam (BRV), an AED. In addition, we aim to visualize these changes in the brain because of priming, possibly altered network-…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Scoring on a composite index combining seizure reduction, improvement of
cognition and quality of life.
Secondary outcome
Seizure reduction, seizure freedom rates, seizure severity, cognition, mood
state, adverse events tVNS and brivaracetam, change in brain network properties
Background summary
The most prevalent neurological disorder with also immense burden of disease,
epilepsy, is in over 30 percent of patients difficult to treat. The ideal
treatment regime would give complete control of disease in an early stage, not
only for patient well-being, but also to prevent the onset of persistent
pathologic epileptic networks in the brain. The first step in treatment is the
trial, and error, of multiple anti-epileptic drugs (AEDs), while invasive brain
stimulation (BS) techniques with network modulating properties are saved as a
last resort. We hypothesize that pharmacotherapeutic treatment of epilepsy can
be more successful after *priming* (preparing) the brain using BS as a
short-term neuromodulation treatment. The limitation of testing this hypothesis
is the invasive aspect of the most used classic vagal nerve stimulation (VNS)
treatment for epilepsy, but the recent development of transcutaneous vagal
nerve stimulation (tVNS) offered a possibility to combine chemical and
electrical modulation in an earlier stage of disease, which is not tested
before.
Study objective
Determine the priming effect on the epileptic brain of tVNS, to make it more
susceptible to treatment with Brivaracetam (BRV), an AED. In addition, we aim
to visualize these changes in the brain because of priming, possibly altered
network-organisation.
Study design
Pretest-posttest study
Intervention
The group receives transcutaneous vagal nerve stimulation (tVNS) 4 hours daily
during brivaracetam treatment.
Study burden and risks
Besides minor temporary side effects no risk is attributed to tVNS. Because of
the study one extra visit is necessary, besides regular clinical follow-up. The
3 visits do require some more time than usual because of the questionnaires,
MRI and short cognitive tests.
The burden of the telephone calls is very limited, since it only consists of a
few short questions.
Patients with claustrophobia are excluded, but the requirement of lying still
can be somewhat uncomfortable.
The eye tracking device uses a camera in the video screen, with no burden at
all.
Groene Loper 19
Eindhoven 5600AB
NL
Groene Loper 19
Eindhoven 5600AB
NL
Listed location countries
Age
Inclusion criteria
focal epilepsy, refractory to treatment after at least 2 different adequatly
dosed anti-epileptic drugs, >17 years of age, IQ>70
Exclusion criteria
Other progressive central neurologic disease in history, inability to give
informed consent, contra-indication for MRI or tVNS, already treatment with
brain stimulation, incapable of handling tVNS device, known cardiac arrhythmia
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| ClinicalTrials.gov | NCT05180916 |
| CCMO | NL73868.015.20 |