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Tests treatment safety and results for Drug Resistant Epilepsy
Official title A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
ClinicalTrials.gov ID: NCT06492720
What this study is testing
- What it's testing
- This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female patients aged over than and equal to 18 years old.
- Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
- Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.
- At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure...
- Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
You likely can't join if
- Patients with concurrent active psychiatric or mood disorders that have been assessed to 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), wounds, or atrophy of the scalp.
- Image documented calcified lesion in the FUS exposure path.
- Abnormal coagulation profile:
- Platelet (PLT) \< 100,000/μL.
See the full eligibility criteria
- Male or female patients aged over than and equal to 18 years old.
- Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
- Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.
- 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.
- 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 have been assessed to 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), wounds, or atrophy of the scalp.
- Image documented calcified lesion in the FUS exposure path.
- Abnormal coagulation profile:
- Platelet (PLT) \< 100,000/μL.
- prothrombin time (PT) \> 15 sec.
- activated partial thromboplastin time (APTT) \> 45 sec.
- international normalized ratio (INR) \> 1.5.
- Patients requiring anticoagulant medications.
- Pregnant or breast-feeding women.
- Coexisting medical problems of sufficient severity to limit compliance with the study.
- Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components; having metallic implants that are assessed as unsuitable for MRI examination.
- Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse.
- Patients have received an investigational drug or an investigational device within 4 weeks prior to the study
- 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...
- Any ASM treatment change during the baseline (screening period).
- Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).
- Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).
- Patient has an IQ \< 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).
- Any other condition that, in the investigator's judgment, patient not applicable to participate this study.
The study team makes the final eligibility decision.
Where it's taking place
- Taipei, Taiwan
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 to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.