Transcranial focused ultrasound pulsation suppresses pentylenetetrazol induced epilepsy in vivo.
Sin-Guang Chen, Chih-Hung Tsai, Chia-Jung Lin...
https://pubmed.ncbi.nlm.nih.gov/31575487Actively Recruiting
Phase Not Applicable
Age: 18Years - 65Years
All Genders
ID06492720
A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial to Evaluate the Safety and Efficacy of NaviFUS™ System Neuromodulating Treatment for Patients with Drug Resistant Epilepsy
Led by NaviFUS Corporation · Updated on 2026-04-09
16
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a device called the NaviFUS System, which uses low-intensity focused ultrasound (LIFU) neuromodulation to study its effects on patients with drug-resistant epilepsy (DRE). This condition involves seizures that have not improved despite trying at least three anti-seizure medications. The study is designed as a pilot, open-label, randomized trial to understand the safety and ability of the device to reduce seizure activity by targeting specific brain regions. Participants in this study will be divided into two groups receiving different doses of the ultrasound treatment. One group will receive three consecutive 5-minute treatments twice a week, while the other group will receive three consecutive 10-minute treatments twice a week. Both treatments use specific ultrasound parameters controlled by the NaviFUS System. Following the treatments, there will be a 24-week follow-up period. Throughout the study, patients may continue their usual anti-seizure medications. Before treatment, participants will undergo an 8-week screening period where they keep a seizure diary to establish a baseline of seizure frequency and severity. This diary will continue throughout the treatment and follow-up periods. Researchers will monitor seizure frequency changes, seizure-free days, seizure strength, quality of life, anxiety, and depression levels. Safety will also be closely observed by tracking any adverse events during the study, which will last up to 33 weeks in total.
CONDITIONS
Brief Title
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 65 years
- Diagnosis of drug-resistant epilepsy with at least 3 failed anti-seizure medications and currently taking 1 to 4 anti-seizure medications
- Epileptogenic focus identified by presurgical evaluation
- At least 4 focal seizures with visible or disabling symptoms during an 8-week baseline and at least one seizure per month
- Able and willing to provide informed consent and comply with study procedures
You will not qualify if you...
- Active psychiatric or mood disorders interfering with study participation
- Presence of pacemaker, implantable cardioverter-defibrillator, permanent medication pumps, cochlear implants, or deep brain stimulation devices
- Scars, scalp disorders, wounds, or atrophy in the ultrasound pathway area on the skull
- Calcified lesions documented in the ultrasound exposure path
- Abnormal blood clotting results or use of anticoagulants
- Pregnant or breastfeeding women
- Medical conditions that limit study compliance
- Allergic to MRI contrast agents or unsuitable for MRI due to metallic implants
- Use or history of recreational drug use, addiction, or substance abuse
- Recent participation in another investigational drug or device study within 4 weeks
- Changes in anti-seizure medication during baseline period
- Recent changes in vagus nerve stimulation or radiofrequency thermocoagulation treatments
- IQ below 70 based on intelligence scale
- Any other condition that may affect study results or patient safety as judged by the investigator or makes the patient unsuitable for participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 8 weeks
Participants are screened for eligibility to participate in the trial.
Participants keep an 8-week seizure diary during this period.
Treatment
Duration - 1 week
Participants receive focused ultrasound (FUS) neuromodulating treatment with assigned doses to reduce seizure activity.
Two treatment sessions in one week with either three consecutive 5-minute or 10-minute FUS exposures per session.
Follow-up
Duration - 24 weeks
Participants continue to record seizure activity and are monitored for safety and treatment effects.
Participants keep seizure diaries and attend follow-up visits during this period.
Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
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Research Team
S
Sheang-Tze Fung, Ph.D.
A
Arthur Lung, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Pulsed-Focused Ultrasound Provides Long-Term Suppression of Epileptiform Bursts in the Kainic Acid-Induced Epilepsy Rat Model.
Po-Chun Chu, Hsiang-Yu Yu, Cheng-Chia Lee...
https://pubmed.ncbi.nlm.nih.gov/35581489Pilot study of focused ultrasound for drug-resistant epilepsy.
Cheng-Chia Lee, Chien-Chen Chou, Fu-Jung Hsiao...
https://pubmed.ncbi.nlm.nih.gov/34729772