PRediction of Vagal Nerve Stimulation EfficaCy In Drug-reSistant Epilepsy

NCT04935567 | Not Yet Recruiting

• 1 other identifier: PRECISE-21
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Vagal nerve stimulation (VNS) can be indicated in patients with drug-resistant epilepsy who are not eligible for resective epilepsy surgery with responders rates about 50% (≥50% seizure reduction). At the moment, there is not a widely-accepted possibility to predict VNS efficacy in a given patient based on pre-implantation data, which can lead to unnecessary surgery and improper allocation of financial resources. The principal aim of PRECISE (PRediction of vagal nerve stimulation EfficaCcy In drug-reSistant Epilepsy) study is to verify the predictability of VNS efficacy by analysis of pre-implantation routine EEG. The PRECISE relies on the results of our previous work, which developed a statistical classifier for VNS response (responders vs. non-responders) based on differences in EEG power spectra dynamics (Pre-X-Stim). PRECISE is designed as a prospective multicentre study in which patients indicated to VNS therapy will be recruited. Patients will be classified as predicted responders vs. predicted non-responders using pre-implantation EEG analyses. After the first and the second year of the study, the real-life outcome (responder vs. non-responder) will be determined. The real-life outcome and predicted outcome will be compared in terms of accuracy, specificity, and sensitivity. In the meantime, the patients will be managed according to the best clinical practice to obtain the best therapeutical response.

Conditions

Drug Resistant Epilepsy

Keywords

Drug-resistant epilepsy; Vagal nerve stimulation; Efficacy predictability; Responders; Non-responders; EEG

Outcome Measures

Primary Outcomes (1)

• Accuracy of statistic model for prediction of response to VNS therapy

  Accuracy of statistic model for prediction of response to VNS therapy in terms of responders and non-responders in drug-resistant epilepsy

  2 years

Secondary Outcomes (2)

• The quantification of differences in EEG power spectra

  2 years

• Prediction of patients' response to VNS therapy

  2 years

Study Arms (2)

Predicted responders

EXPERIMENTAL

Patients indicated VNS therapy as their standard for clinical care and are concerned about the prediction of VNS efficacy based on pre-implantation EEG, (≥50% seizure reduction).

Other: Statistical model for the prediction of VNS efficacy

Predicted non-responders

ACTIVE COMPARATOR

Patients indicated VNS therapy as their standard for clinical care and are concerned about the prediction of VNS efficacy based on pre-implantation EEG, (\<50% seizure reduction).

Other: Statistical model for the prediction of VNS efficacy

Interventions

Statistical model for the prediction of VNS efficacy OTHER

statistical model for the prediction of VNS efficacy based on a mathematical and statistical analysis of scalp EEG data

Also known as: the verification of the real-life validity of the statistic classifier for prediction of VNS response based on pre-implantation EEG

Predicted non-responders; Predicted responders

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Drug-resistant epilepsy indicated to VNS based on clinical decision.
• Drug-resistant epilepsy is defined as a failure of adequate trials of two tolerated, appropriately chosen, and used antiepileptic drug schedules (whether as monotherapy or in combination) to achieve sustained seizure freedom (Kwan et al., 2010).
• Age ≥ 18 years
• Availability to record 20 minutes of EEG with photic stimulation, hyperventilation, and eye-opening/closing according to the pre-defined protocol.
• Availability of seizure diaries at least three months before VNS implantation OR reliable information about seizure frequency at least three months before VNS implantation
• The ability of a patient/family member/caregiver to record seizures precisely into seizure diaries OR the ability of a patient/family member/caregiver to report seizures precisely different ways.
• In cases with very high seizure frequency (several seizures per day), it is acceptable to report only the days without any seizures.

You may not qualify if:

• The indication and planning of resection brain surgery as a treatment option for drug-resistant epilepsy. If a patient clearly demonstrates his refusal of resection surgery, he/she can be included in the study.
• The presence of psychogenic non-epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient/family member/caregiver.
• The presence of other condition which can resemble epileptic seizures which cannot be reliably distinguished from epileptic seizures by a patient/family member/caregiver.
• Metabolic condition or other diseases, in which the increase of seizure frequency is expectable.
• The inability of a patient to take regular visits which are required for VNS parameters settings or the study
• Life expectancy shorter than two years

Sponsors & Collaborators

• Masaryk University: lead
• St. Anne's University Hospital Brno, Czech Republic: collaborator
• University Hospital, Motol: collaborator
• Na Homolce Hospital: collaborator

Study Sites (1)

University Hospital St. Anne´s Brno

Brno, 654 91, Czechia

Location

Related Publications (1)

• Dolezalova I, Koritakova E, Souckova L, Chrastina J, Chladek J, Stepanova R, Brazdil M. Prediction of Vagal Nerve Stimulation Efficacy in Drug-Resistant Epilepsy (PRECISE): Prospective Study for Pre-implantation Prediction/Study Design. Front Neurol. 2022 Mar 21;13:839163. doi: 10.3389/fneur.2022.839163. eCollection 2022.

  PMID: 35386419 DERIVED

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Models, Statistical

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Models, Theoretical; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Milan Brazdil, Prof.

  University Hospital st. Anne´s Brno

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Milan Brazdil, Prof.

CONTACT

+420 543 182 684; milan.brazdil@fnusa.cz

Irena Doležalová, MD

CONTACT

+420 543 182 654; irena.dolezalova@fnusa.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: PRECISE is a prospective multicentre study for prediction VNS efficacy based on pre-implantation EEG data. The patients with drug-resistant epilepsy will undergo standard VNS implantation based on a clinical decision. Before implantation, the scalp EEG, according to the study protocol, will be recorded. The EEG will be mathematically processed, and the patient´s predicted outcome in terms of predicted responder vs. predicted non-responders will be statistically determined. The stimulation parameters and AEDs therapy will be modified according to the best clinical practice. The real-life outcome will be determined by percent seizure reduction. Subsequently, the real-life and predicted outcome will be compared in terms of accuracy, sensitivity, and specificity. The main goal is to validate Pre-X-Stim in a real-life prospective study.

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 23, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)