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NCT06292494Toboroz

Focused Ultrasound for Drug-resistant Epilepsy

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 16.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toboroz
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
10 (tervezett)
Első benyújtás
2023. dec. 10.
Kezdés
2024. jan. 1.
Elsődleges befejezés
2027. dec. 31.
Fő szponzor
Taipei Veterans General Hospital, Taiwan
Betegségek
Epilepszia
NCT-szám
NCT06292494

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 10
  • 2024. jan. 1. és az elsődleges befejezés (2027. dec. 31.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • This product is not suitable for individuals with contraindications related to MRI, such as those with metallic implants, those unable to undergo MRI, severe claustrophobia, or those with adverse reactions to contrast agents.
  • Individuals with implants in the brain or skull, such as shunts, electrodes, hard brain membrane patches, or electrode plates, that cannot be avoided along the expected path of brain ultrasound.
  • Patients along the expected path of brain ultrasound who cannot avoid structures or sensitive tissues with energy absorption (e.g., previous brain shunt surgery sites, surgical metal clips, or any hard implants).
  • Patients taking or injecting anticoagulant medications such as aspirin, coumadin, heparin, novel oral anticoagulants (NOACs), etc., which may lead to prolonged bleeding. Medication should be discontinued for 3-7 days before treatment.
  • Substance abuse (use of illegal drugs or using medications in a manner not recommended by a physician or manufacturer) or alcohol addiction.
  • Patients who have taken medications affecting the central nervous system within the past six months (e.g., central nervous system stimulants, sympathomimetic agents).

Más betegség

  • Patients with other high-risk brain disorders (e.g., intracranial aneurysm).
  • Patients with intraoperative or postoperative bleeding risk:
    • Those with a history of cerebrovascular disease (multiple strokes or strokes within the past six months) or a history of cerebral hemorrhage and stroke.
    • Those with abnormal bleeding, intracranial bleeding, coagulation disorders, or a history of bleeding or clotting disorders, either during or after surgery.
  • Patients with severe uncontrolled hypertension (systolic blood pressure > 180 mmHg after stable medication, diastolic blood pressure > 100 mmHg).
  • Unstable cardiac conditions (heart rate > 180 beats/minute or < 40 beats/minute; systolic blood pressure > 180 mmHg or < 90 mmHg).
  • Patients with psychological abnormalities (e.g., schizophrenia, severe depression, bipolar disorder).
  • Individuals with severe head surface injuries or potential allergies to materials in contact with the head (such as conductive gels, head silicone membranes)

Egyéb

  • Patients with extensive scabbing along the expected path of brain ultrasound.
  • Patients who have used contrast agents (e.g., MRI, ultrasound) within the past 24 hours before treatment.
  • Patients unable to communicate with the physician during the treatment process.

Kiket keres a vizsgálat

  • Patients aged 18 and above.
  • Localized refractory epilepsy (ineffective with maximum doses of two or more anti-seizure medications).
  • Seizure frequency records for at least one month prior to the trial.
  • Patients who have undergone a complete preoperative examination, including EEG, MRI, and positron emission tomography (PET).
  • Capable of undergoing high-resolution computed tomography (CT scan), and SDR (Skull Density Ratio) ≥ 0.3.
  • Must have a body type suitable for entry into the magnetic resonance imaging (MRI) machine and be able to tolerate MRI scans.
  • During the surgical procedure, communication with the physician and the expression of sensory perceptions are essential; general anesthesia is not required.
  • Must be able to voluntarily press the stop button.
  • Willing to undergo removal of hair from the treatment site.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Taipei Veterans General HospitalTaipeiTajvanToboroz

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