RECRUITING

A Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Epilepsy

Conditions

Drug Resistant Epilepsy Epilepsy NaviFUS System Focused Ultrasound Low-Intensity Focused Ultrasound

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Prospective, Open-label, Single-arm, Multi-center, Pilot Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Low-intensity Focused Ultrasound Neuromodulation in Patients With Drug-resistant Unilateral or Bilateral Temporal Lobe Epilepsy

Quick Facts

Study Start:2024-09-13

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06388707

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Sheang-Tze Fung, Ph.D.

CONTACT

02-25860560

stfung@navifus.com

Arthur Lung, Ph.D.

CONTACT

arthur.lung@navifus.com

Study Locations (Sites)

Stanford University School of Medicine

Palo Alto, California, 94305

United States

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

University of Virginia School of Medicine

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: NaviFUS Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-13

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-09-13

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

NaviFUS System
Focused Ultrasound
Low-Intensity Focused Ultrasound

Additional Relevant MeSH Terms

Drug Resistant Epilepsy
Epilepsy