Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06292494

Focused Ultrasound for Drug-resistant Epilepsy

Led by Taipei Veterans General Hospital, Taiwan · Updated on 2025-09-09

20

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

T

Taipei Veterans General Hospital, Taiwan

Lead Sponsor

I

InSightec

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Focused Ultrasound for Drug-resistant Epilepsy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 20 and above.
  • Localized refractory epilepsy not responding to maximum doses of two or more anti-seizure medications.
  • Seizure frequency records available for at least one month before the trial.
  • Completion of preoperative examinations including EEG, MRI, and PET.
  • Able to undergo high-resolution CT scan with skull density ratio (SDR) of 0.3 or higher.
  • Body size suitable for MRI scanner entry and able to tolerate MRI scans.
  • Able to communicate with physician and express sensory perceptions during treatment without general anesthesia.
  • Able to voluntarily press the stop button during the procedure.
  • Willing to have hair removed from the treatment site.
Not Eligible

You will not qualify if you...

  • Contraindications to MRI such as metallic implants, inability to undergo MRI, severe claustrophobia, or allergies to contrast agents.
  • Presence of brain or skull implants like shunts, electrodes, hard brain membrane patches, or electrode plates in the ultrasound path.
  • Structures or sensitive tissues along ultrasound path that cannot be avoided (e.g., prior brain shunt sites, metal clips, hard implants).
  • Extensive scabbing along the ultrasound path.
  • Use of contrast agents within 24 hours before treatment.
  • High-risk brain disorders such as intracranial aneurysm.
  • History of cerebrovascular disease or cerebral hemorrhage within six months.
  • Abnormal bleeding or clotting disorders or history of bleeding complications.
  • Use of anticoagulant medications requiring discontinuation 3-7 days before treatment.
  • Severe uncontrolled hypertension (systolic >180 mmHg or diastolic >100 mmHg).
  • Inability to communicate with physician during treatment.
  • Unstable heart conditions (heart rate >180 or <40 beats/min; systolic >180 or <90 mmHg).
  • Substance abuse or alcohol addiction.
  • Use of central nervous system-affecting medications within past six months.
  • Psychological disorders such as schizophrenia, severe depression, or bipolar disorder.
  • Severe head surface injuries or allergies to materials contacting the head (e.g., conductive gels, silicone membranes).

AI-Screening

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Trial Site Locations

Total: 1 location

1

Taipei Veterans General Hospital

Taipei, Taiwan

Actively Recruiting

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Research Team

C

Cheng-Chia Lee, MD. PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Focused Ultrasound for Drug-resistant Epilepsy | DecenTrialz