NCT06388707 A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy
| NCT ID | NCT06388707 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | NaviFUS Corporation |
| Condition | Drug Resistant Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 8 participants |
| Start Date | 2024-09-13 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 8 participants in total. It began in 2024-09-13 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients ≥ 18 years of age at the time of enrollment. 2. 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 combination). 3. 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. 4. 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. 5. MRI and EEG within the past 3 years. At least one prior EEG should demonstrate interictal or ictal focal epileptiform findings. 6. Patients with the central of FUS exposure region are located at least 30 mm distance beneath the skull bone. 7. 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. 8. 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 acceptable method of contraception (as outlined below) from prior to the first study treatment to 3 months after the last study treatment. Standard acceptable methods include use of highly effective method of contraception, including: hormonal contraception, diaphragm, cervical cap, vaginal sponge, condom, spermicide, vasectomy, intrauterine device, and abstinence from sex. 9. 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). 10. Patients are able to complete all clinical trial-related questionnaires in English, including with the use of a suitable interpreter. 11. 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. Exclusion Criteria: 1. Patients who have primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures. 2. Patients who have experienced tonic-clonic status epilepticus in the 12 months before the time of enrollment in the study. Subjects with focal status epilepticus may be considered at the discretion of the Investigator. 3. The only feasible sonication pathway to the seizure onset zones involves either: 1. Skull area is covered by previous surgical site(s), scars, scalp disorders (e.g., eczema, psoriasis), or scalp atrophy. 2. Clips or other metallic implanted objects in the skull or brain, except shunts. 3. A prior craniotomy site. 4. Patients with a potentially acute or progressive neurologic disorder (e.g., brain tumor, multiple sclerosis, dementia, or intracranial vascular lesion). 5. Implanted electronic device, for example, implanted cardioverter-defibrillator (ICD), cardiac pacemaker, permanent medication pumps, cochlear implants, responsive neurostimulator, deep brain stimulation (DBS), or other electronic devices implanted in the brain. If a patient has a working Vagus Nerve Stimulator (VNS) in place, the settings should remain stable throughout the trial and the device will be turned off prior to each sonication treatment and then turned back on afterward. 6. 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 enrollment. 7. Patient has an IQ \< 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-II or other Wechsler IQ measure). 8. Coexisting medical problems of sufficient severity to limit compliance with or interpretation of the study. 9. Patients have received an investigational drug or an investigational device within 4 weeks prior to the first treatment. 10. Radiofrequency thermocoagulation (RFTC) within 2 months before time of enrollment. 11. Known history of substance or alcohol abuse within the past year, not counting marijuana. 12. Pregnant or breast-feeding women. 13. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06388707 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06388707 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06388707 currently recruiting?
Yes, NCT06388707 is actively recruiting participants. Contact the research team at stfung@navifus.com for enrollment information.
Where is the NCT06388707 trial being conducted?
This trial is being conducted at Palo Alto, United States, Boston, United States, Charlottesville, United States.
Who is sponsoring the NCT06388707 clinical trial?
NCT06388707 is sponsored by NaviFUS Corporation. The trial plans to enroll 8 participants.
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