Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05180916 |
| Other study ID # |
PREP_001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
July 1, 2023 |
Study information
| Verified date |
December 2021 |
| Source |
Eindhoven University of Technology |
| Contact |
Angelique A Stuurman, Msc |
| Phone |
0031402279777 |
| Email |
prep[@]tue.nl |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. The investigators 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. The investigators want to determine the priming effect on the epileptic brain of
tVNS, to make it more susceptible to add-on treatment with Brivaracetam (BRV), an AED. In
addition, the investigators aim to visualize these changes in the brain because of priming,
possibly altered network-organisation.
Description:
Background of the study: 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. The investigators 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.
Objective of the study: Determine the priming effect on the epileptic brain of tVNS, to make
it more susceptible to add-on treatment with Brivaracetam (BRV), an AED. In addition, the
investigators aim to visualize these changes in the brain because of priming, possibly
altered network-organisation.
Study design: Randomized Controlled Trial. Study population: Adults with a refractory
(continuing of seizures despite 2 tried AEDs) focal epilepsy and therefore have an indication
for start of Brivaracetam. Intervention (if applicable): One group receives transcutaneous
vagal nerve stimulation (tVNS) 4 hours daily for the first 3 months of brivaracetam
treatment. Primary study parameters/outcome of the study: Scoring on a composite index
combining seizure reduction, improvement of cognition and quality of life. Secondary study
parameters/outcome of the study (if applicable): Seizure reduction, seizure freedom rates,
seizure severity, cognition, mood state, adverse events tVNS and brivaracetam, change in
brain network properties.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness (if applicable): 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.
