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Focused Ultrasound for Drug-resistant Epilepsy

NCT06292494 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-09

No results posted yet for this study

Summary

Focused ultrasound (FUS) has been shown to differentially lesion or modulate (excite and inhibit) brain circuit and neural activity across a broad range of acoustic stimulus parameters (intensity, duty cycle, pulse repetition frequency and pulse duration) for decades. From our previous study, FUS sonication may suppress the number of epileptic signal bursts observed in EEG recordings after the induction of acute epilepsy. The presence of the suppressive effect was found in terms of the number of epileptic EEG spikes from the analysis of the unfiltered and theta-band EEG activity, and further discontinue the seizure attacks. EEG activity has also been consistently reported to have a positive correlation with the level of epilepsy, and FUS-mediated reduction of epileptic EEG activity was most notably observed, no matter lesioning or modulating effects. The aims of this study are to demonstrate the safety and efficacy of FUS technology in epilepsy patients and to estimate the optimal parameters of focused ultrasound exposure that will be used in the case of epilepsy.

Conditions

  • Focused Ultrasound
  • MR-guided FUS
  • Drug Refractory Epilepsy
  • Drug Resistant Epilepsy
  • Medication Resistant Epilepsy

Interventions

DEVICE

Exablate 4000 Transcranial MRgfUS System

Focused ultrasound interrupt structure of epilepsy network to improve seizure.

Sponsors & Collaborators

  • InSightec

    collaborator INDUSTRY

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Principal Investigators

  • Cheng-Chia Lee, MD. PhD. · Taipei Veterans General Hospital, Taiwan

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06292494 on ClinicalTrials.gov