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Evaluation of ANT-DBS Neuromodulation with Sensing Electrodes (EANSkE)

Evaluation of ANT-DBS Neuromodulation with Sensing Electrodes (EANSkE) - EANSkE

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56397
Enrollment
40
Registered
2020-06-23
Start date
2021-03-15
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Epilepsy medically refractory epilepsy Epilepsy

Interventions

Not applicable.

Sponsors

Medisch Spectrum Twente (MST)
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult (>=18 year) patients with medically refractory epilepsy, who are  candidates for ANT-DBS or who already have an ANT-DBS implant.Implantable pulse generator that allows recording of LFPs (Medtronic Percept  system).

Exclusion criteria

Exclusion criteria: Patients with cognitive impairments that causes the patient to be unable to understand the research purpose and give informed consent will be excluded in this study.

Design outcomes

Primary

MeasureTime frame
The primary goal of the study is to identify biomarkers from LFPs recorded from the DBS electrodes that are associated with treatment response to DBS in patients with epilepsy. Hereby, treatment response is defined by the percentual seizure reduction.

Secondary

MeasureTime frame
- To characterize the short and long latency DBS evoked potentials recorded on the scalp with 64-channels EEG - To predict success of DBS in patients with epilepsy using pre-operative features from resting-state 64-channel EEG and MRI. We will initially aim to predict responders (>50% seizure reduction at 12 and 24 months after DBS implantation); this binarized response will be complemented by assessing the likelihood of seizure reduction on a continuous scale. - To improve insight in the role of the thalamocortical network in patients with epilepsy by studying the relation of simultaneous measured LFP recording of the ANT and 64-channel surface EEG recording. - To study differences in network characteristics derived from 64-channel EEG, and MRI before and after DBS. - To evaluate the effect of ANT DBS on memory functions (pre- vs post-implantation) tested using standardized neuropsychological examination. - To evaluate the differences in the power spectral density of ictal (during a seizure) and interictal (when the patient is not having a seizure) LFP measurements. - To characterize the short and long latency VNS evoked potentials recorded on the scalp with 64-channels EEG, in the subgroup of patient who also have a vagus nerve stimulator (VNS) implanted.

Countries

Netherlands

Contacts

Public ContactM.C. Tjepkema-Cloostermans

Medisch Spectrum Twente (MST)

neurologie@mst.nl053-4872850

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Aug 15, 2026