Enhancing Epilepsy Management With Precision Deep Brain Stimulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNova Scotia Health Authority

About this trial

The goal of this study is to evaluate the effectiveness of objective neural response feedback on deep brain stimulation (DBS) programming for drug-resistant epilepsy in a prospective observational cohort study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients qualifying for deep brain stimulation on the basis of drug-resistant epilepsy

Informed consent

Disqualifiers

Lack of consent

Electrical or other devices that preclude the performance of an MRI for pre-operative imaging

Trial design

Design model

Single group

Treatments tested in this trial

  • Neuromodulation programming

    Device

    Participants will be brought in for their standard follow-up appointments at 4-weeks, 4-months, and 1-year post-surgery. In addition to the routine care, physiological data will be extracted from the implanted device and analyzed. The physiological data will be considered along with the standard epilepsy diary to assess epileptic burden and inform device programming. Quality of life will be measured with a series of standard questionnaires pre-surgery and at the 1-year follow-up.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Participant GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Seizure reduction

The number of seizures experienced by patients will be assessed by the number of seizures recorded by patients and their caregivers in seizure diaries and described as absolute seizure reduction.

Time frame
Change from baseline versus Month 12

Secondary outcomes

1

Change in disease score on Patient Weighted Quality Of Life In Epilepsy

Assessment of therapeutic effects using Patient Weighted Quality Of Life In Epilepsy, a 10-question survey completed by patients to assess quality of life, where a higher score is associated with a more positive quality of life.

Time frame
Twelve months
2

Change in depression score on Neurological Disorders Depression Inventory in Epilepsy

Assessment of therapeutic effects using Neurological Disorders Depression Inventory in Epilepsy, a 6-question survey to assess depression. A higher score is associated with more severe depression.

Time frame
Twelve months
3

Change in anxiety score on Anxiety General Anxiety Disorder-7

Assessment of therapeutic effects using Anxiety General Anxiety Disorder-7, a 7-question survey to assess anxiety. A higher score is associated with more severe anxiety, and a lower score is associated with minimal anxiety.

Time frame
Twelve months

Other outcomes

Sponsors and contacts

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