NCT06492720

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
11mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Sep 2024Mar 2027

First Submitted

Initial submission to the registry

July 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.3 years

First QC Date

July 1, 2024

Last Update Submit

April 6, 2026

Conditions

Seizures, FocalDrug Resistant EpilepsyEpilepsyEpilepsy, Temporal Lobe

Keywords

NaviFUS SystemFocused UltrasoundLow-Intensity Focused UltrasoundLIFU

Outcome Measures

Primary Outcomes (1)

  • Changes of seizure frequency after treatment compared to baseline

    The changes in patient's seizure frequency from baseline through the study completion will be assessed based on the seizure diaries.

    up to 33 weeks

Secondary Outcomes (7)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    up to 33 weeks

  • Responder rate (≧50% seizure reduction)

    up to 33 weeks

  • Change from baseline in number of seizure-free days

    up to 33 weeks

  • Change from baseline in subjective seizure strength

    up to 33 weeks

  • Quality of Life in Epilepsy (QOLIE-31)

    up to 33 weeks

  • +2 more secondary outcomes

Study Arms (2)

Low dose group FUS treatment

EXPERIMENTAL

FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals.

Device: Focused ultrasound (FUS) treatment

High dose group FUS treatment

EXPERIMENTAL

FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: three consecutive 10-minute FUS exposures with two 5-minute intermission intervals.

Device: Focused ultrasound (FUS) treatment

Interventions

Focused ultrasound (FUS) treatmentDEVICE

The mechanism of action of FUS neuromodulation involves the activation of voltage-gated ion channels to induce temporary neuromodulation.

High dose group FUS treatmentLow dose group FUS treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 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.

You may not qualify 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.
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Related Publications (3)

  • Chen SG, Tsai CH, Lin CJ, Lee CC, Yu HY, Hsieh TH, Liu HL. Transcranial focused ultrasound pulsation suppresses pentylenetetrazol induced epilepsy in vivo. Brain Stimul. 2020 Jan-Feb;13(1):35-46. doi: 10.1016/j.brs.2019.09.011. Epub 2019 Sep 24.

    PMID: 31575487BACKGROUND

  • Chu PC, Yu HY, Lee CC, Fisher R, Liu HL. Pulsed-Focused Ultrasound Provides Long-Term Suppression of Epileptiform Bursts in the Kainic Acid-Induced Epilepsy Rat Model. Neurotherapeutics. 2022 Jul;19(4):1368-1380. doi: 10.1007/s13311-022-01250-7. Epub 2022 May 17.

    PMID: 35581489BACKGROUND

  • Lee CC, Chou CC, Hsiao FJ, Chen YH, Lin CF, Chen CJ, Peng SJ, Liu HL, Yu HY. Pilot study of focused ultrasound for drug-resistant epilepsy. Epilepsia. 2022 Jan;63(1):162-175. doi: 10.1111/epi.17105. Epub 2021 Nov 2.

    PMID: 34729772BACKGROUND

MeSH Terms

Conditions

Drug Resistant EpilepsyEpilepsyEpilepsy, Temporal LobeSeizures

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpilepsies, PartialEpileptic SyndromesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Sheang-Tze Fung, Ph.D.

CONTACT

02-25860560stfung@navifus.com

Arthur Lung, Ph.D.

CONTACT

arthur.lung@navifus.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2024

First Posted

July 9, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)