None listed
Conditions
Brief summary
In this research project we will expand the scope of intracranial evaluations to include placement of electrodes in deep structures of the brain, and to perform temporary 'trials' of stimulation to mimic various treatment strategies. This will help us to choose the best intervention for these people and to design DBS systems personalised to their epilepsy. We will then evaluate whether these personalised DBS systems show seizure reduction exceeding that reported in existing DBS studies.
Interventions
Participants can undergo either or both interventions. (A) always occurs before (B), however, (A) is not required for enrolment in (B).
A) Extended Intracranial Evaluation – extended sampling and temporary stimulation of candidate Deep Brain Stimulation (DBS) targets during stereo-EEG (SEEG) evaluations. SEEG is a type of invasive intracranial evaluation involving the implantation of depth electrodes using a stereotactic surgical frame. Its aim is to more accurately define the brain regions inv
Participants can undergo either or both interventions. (A) always occurs before (B), however, (A) is not required for enrolment in (B). A) Extended Intracranial Evaluation – extended sampling and temporary stimulation of candidate Deep Brain Stimulation (DBS) targets during stereo-EEG (SEEG) evaluations. SEEG is a type of invasive intracranial evaluation involving the implantation of depth electrodes using a stereotactic surgical frame. Its aim is to more accurately define the brain regions involved in an individual's seizures, using recordings of electrical activity between and during seizures. (A) Standard intracranial evaluations (e.g. SEEG) typically last 7–10 days, with our extended intracranial evaluation adding up to 2 additional days (7–12 days total). Temporary stimulation of candidate DBS targets will be performed by a study neurologist near the end of the admission. Stimulation trials will have parameters designed to mimic chronic DBS stimulation parameters and multiple parameter sets will be trialled of varying duration within safe charge density limits. The change in EEG-based biomarkers will be evaluated to assess the individual patient's response to each parameter set. The extended intracranial evaluation occurs once, to help treating clinicians decide on treatment for the individual's epilepsy, and follows standard neurosurgical procedure. As participants are admitted to hospital throughout the evaluation, adherence is maintained through continuous clinical monitoring. B) Personalised DBS – DBS targets and stimulation parameters designed based on either results from (A) or standard-of-care evaluations. (B) Participants undergoing personalised DBS will have their DBS system designed based on all available information – from standard-of-care (non-invasive) assessments through to our extended intracranial (invasive) evaluation. Stimulation target and parameters (e.g. amplitude, frequency) will be personalised to the individual's epilepsy, with parameters kept within safe charge density limits. DBS implantation will follow standard neurosurgical procedure. Adherence is supported by stimulation parameters being clinician-programmed and reviewed at scheduled follow-up appointments or ad-hoc if side effects occur. All patients undergoing an intracranial evaluation will be offered an extended intracranial evaluation. All patients undergoing DBS will be offered personalised DBS. Standard of care will be given to those that opt-out, or those that do not meet inclusion criteria (e.g. <18yrs).
Sponsors
The Alfred
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must: - Be aged 18 years or over. - Have a diagnosis of drug-resistant epilepsy (according to ILAE criteria). - Be able to read and speak English. - Be medically and neurologically stable, aside from epilepsy, as judged by one of their clinicians or investigators. - Be reasonably expected to maintain a seizure diary, alone or with the assistance of a competent individual. - Be able to complete regular study visits and telephone or telehealth appointments in accordance with the study protocol. Group A (Extended Intracranial Evaluation): - Be under consideration for, have been recommended to have, or are planned to undergo intracranial EEG using one of the following modalities: (i) stereo-EEG, or (ii) subdural grids/strips and depth electrodes. Group B (Personalised DBS): - Be under consideration for, have been recommended to have, or are planned to undergo DBS or VNS for epilepsy.
Exclusion criteria
Participants will not be enrolled if any of the following apply: • Presence of unstable or terminal medical conditions • Severe or unstable psychiatric condition, that in the judgement of the participant’s treating neurologist/epileptologist, psychiatrist, or an investigator would preclude the ability to participate in the trial or where participation would represent a risk for the participant • Severe psychiatric condition that has not been assessed formally by a neuropsychiatrist • Moderate to severe cognitive or intellectual impairment, that in the judgement of the participant’s treating neurologist/epileptologist, psychologist, psychiatrist, or an investigator would preclude the ability to participate in the trial • Active suicidal plan/intent in the past 6 months, history of suicide attempt within 2 years, or more than one lifetime suicide attempt • Subjects unable to consent for themselves • Presence of undue surgical risk, in the view of an investigator, including but not limited to o Bleeding diathesis o Inability to tolerate a general anaesthetic o Participants for whom either subcortical sampling OR trial stimulation carries excessive risk, in the opinion of the managing neurologist, neurosurgeon, or investigator • Recent scalp infection of skin breakdown within the previous 6 weeks • Recent surgical procedure within the previous 6 weeks that would constitute an unacceptably high risk of infection
Outcome results
None listed