Augmenting the sensitivity of the epileptic brain to anti-epileptic drugs by applying transcutaneous vagal nerve stimulation that changes the excitability of the cortex and influences network plasticity.

Augmenting the sensitivity of the epileptic brain to anti-epileptic drugs by applying transcutaneous vagal nerve stimulation that changes the excitability of the cortex and influences network plasticity. - Priming the epileptic brain (PREP)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52498

Enrollment

Registered

2020-08-13

Start date

2022-08-05

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

epilepsy falling sickness

Interventions

The group receives transcutaneous vagal nerve stimulation (tVNS) 4 hours daily during brivaracetam treatment.

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Scoring on a composite index combining seizure reduction, improvement of cognition and quality of life.	—

Secondary

Measure	Time frame
Seizure reduction, seizure freedom rates, seizure severity, cognition, mood state, adverse events tVNS and brivaracetam, change in brain network properties	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)