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Tests treatment safety and results for Drug Resistant Epilepsy
Official title A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
ClinicalTrials.gov ID: NCT06388707
What this study is testing
- What it's testing
- This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients ≥ 18 years of age at the time of enrollment.
- Patients with drug-resistant temporal lobe epilepsy (DR-TLE), defined as failure of adequate trials of two tolerated, appropriately chosen and used...
- Focal-onset seizures with or without secondary generalization and no more than two known seizure onset zones (seizure foci), at least one which is in...
- At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure...
- MRI and EEG within the past 3 years. At least one prior EEG should demonstrate interictal or ictal focal epileptiform findings.
You likely can't join if
- Patients who have primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures.
- Patients who have experienced tonic-clonic status epilepticus in the 12 months before the time of enrollment in the study. people with focal status...
- The only feasible sonication pathway to the seizure onset zones involves either:
- Skull area is covered by previous surgical site(s), scars, scalp disorders (e.g., eczema, psoriasis), or scalp atrophy.
- Clips or other metallic implanted objects in the skull or brain, except shunts.
- A prior craniotomy site.
See the full eligibility criteria
Who can join
- Male or female patients ≥ 18 years of age at the time of enrollment.
- Patients with drug-resistant temporal lobe epilepsy (DR-TLE), defined as failure of adequate trials of two tolerated, appropriately chosen and used anti-epileptic drug schedules (whether as monotherapies or in...
- Focal-onset seizures with or without secondary generalization and no more than two known seizure onset zones (seizure foci), at least one which is in the mesial temporal lobe.
- At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.
- MRI and EEG within the past 3 years. At least one prior EEG should demonstrate interictal or ictal focal epileptiform findings.
- Patients with the central of FUS exposure region are located at least 30 mm distance beneath the skull bone.
- Patients must be on a stable regimen of anti-epileptic drugs (AEDs) for at least 30 days at the time of enrollment, except for rescue benzodiazepines or occasional extra doses of ongoing medicines, as required.
- Females of childbearing potential must have a negative pregnancy test prior to the first treatment. Females of childbearing potential and male patients with a partner of childbearing potential must agree to follow...
- Patients are able and willing to have their hair shaved in the region where the coupling membrane will touch (or if they prefer, whole head).
- Patients are able to complete all clinical trial-related questionnaires in English, including with the use of a suitable interpreter.
- Patients or their legal representatives are able to provide written informed consent for participation in the trial and comply with study requirements in the opinion of the Investigator during the study period.
What rules you out
- Patients who have primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures.
- Patients who have experienced tonic-clonic status epilepticus in the 12 months before the time of enrollment in the study. people with focal status epilepticus may be considered at the discretion of the Investigator.
- The only feasible sonication pathway to the seizure onset zones involves either:
- Skull area is covered by previous surgical site(s), scars, scalp disorders (e.g., eczema, psoriasis), or scalp atrophy.
- Clips or other metallic implanted objects in the skull or brain, except shunts.
- A prior craniotomy site.
- Patients with a potentially acute or progressive neurologic disorder (e.g., brain tumor, multiple sclerosis, dementia, or intracranial vascular lesion).
- Implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator, deep brain stimulation (DBS), or other...
- Patients with severe depression, active suicidal ideation or behavior (as per the C-SSRS), active psychosis (excluding time-limited postictal psychosis), or psychiatric hospitalization in the year before time of...
- Patient has an IQ \< 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-II or other Wechsler IQ measure).
- Coexisting medical problems of sufficient severity to limit compliance with or interpretation of the study.
- Patients have received an investigational drug or an investigational device within 4 weeks prior to the first treatment.
- Radiofrequency thermocoagulation (RFTC) within 2 months before time of enrollment.
- Known history of substance or alcohol abuse within the past year, not counting marijuana.
- Pregnant or breast-feeding women.
- Any other condition that, in the Investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of...
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
- Boston, Massachusetts, United States
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States; Boston, Massachusetts, United States; Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.