CompletedNot Applicable

NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

Taiwan12 participantsStarted 2021-10-07

Plain-language summary

To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients aged ≥20 years old.
✓. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
✓. An epileptogenic foci is determined by comprehensive presurgical evaluation
✓. Seizure number is countable and had been recorded at least 6 times within 2-month in medical history before screening period.
✓. Seizure number had been recorded at least 3 times within 28-day screening period.
✓. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.

✕. Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would interfere with participation in the study.
✕. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS)
✕. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
✕. Clips or other metallic implanted objects in the FUS exposure path, except shunts.
✕. Abnormal coagulation profile:
✕. Platelet (PLT) \< 100,000/μL.
✕. prothrombin time (PT) \>14 sec.
✕. activated partial thromboplastin time (APTT) \>36 sec.

Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients

Timeframe: up to 2 months

NCT IDNCT04999046

SponsorNaviFUS Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-05-13

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male or female patients aged ≥20 years old.
✓. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
✓. An epileptogenic foci is determined by comprehensive presurgical evaluation
✓. Seizure number is countable and had been recorded at least 6 times within 2-month in medical history before screening period.
✓. Seizure number had been recorded at least 3 times within 28-day screening period.
✓. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.

✕. Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would interfere with participation in the study.
✕. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS)
✕. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
✕. Clips or other metallic implanted objects in the FUS exposure path, except shunts.
✕. Abnormal coagulation profile:
✕. Platelet (PLT) \< 100,000/μL.
✕. prothrombin time (PT) \>14 sec.
✕. activated partial thromboplastin time (APTT) \>36 sec.