Last reviewed · How we verify

NCT02804230

MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy (EP001)

Status unknown NA Last updated 10 September 2022
What this trial tests

NA trial testing Neuro Ablation - Functional in Epilepsy in 20 participants. Status unknown.

Timeline
7 June 2016
Primary endpoint
23 June 2023
30 June 2023

Quick facts

Lead sponsorInSightec
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment20
Start date7 June 2016
Primary completion23 June 2023
Estimated completion30 June 2023
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

InSightec — full company profile →

Who can join

Adults 18 to 80, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate the feasibility, safety, and initial effectiveness of Exablate thermal ablation of a focal epileptic target area in the brain of patients suffering from medication-refractory epilepsy, using the Exablate transcranial system to produce multiple sonications targeted in the focus of interest. The investigators will establish the feasibility and collect data to establish the basic safety of this type of treatment as the basis for later studies that will evaluate its full clinical efficacy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Clinical Intervention Using Focused Ultrasound (FUS) Stimulation of the Brain in Diverse Neurological Disorders.
    Baek H, Lockwood D, Mason EJ, Obusez E, et al · · 2022 · cited 48× · PMID 35614924 · DOI 10.3389/fneur.2022.880814
  2. Magnetic Resonance-Guided Focused Ultrasound : Current Status and Future Perspectives in Thermal Ablation and Blood-Brain Barrier Opening.
    Lee EJ, Fomenko A, Lozano AM. · · 2019 · cited 45× · PMID 30630292 · DOI 10.3340/jkns.2018.0180
  3. Current and emerging brain applications of MR-guided focused ultrasound.
    Meng Y, Suppiah S, Mithani K, Solomon B, et al · · 2017 · cited 29× · PMID 29034095 · DOI 10.1186/s40349-017-0105-z
  4. How technology is driving the landscape of epilepsy surgery.
    Dorfer C, Rydenhag B, Baltuch G, Buch V, et al · · 2020 · cited 27× · PMID 32227349 · DOI 10.1111/epi.16489
  5. Magnetic Resonance-Guided Focused Ultrasound in Neurosurgery: Taking Lessons from the Past to Inform the Future.
    Jung NY, Chang JW. · · 2018 · cited 24× · PMID 30369860 · DOI 10.3346/jkms.2018.33.e279
  6. Low Intensity Focused Ultrasound for Epilepsy- A New Approach to Neuromodulation.
    Bubrick EJ, McDannold NJ, White PJ. · · 2022 · cited 22× · PMID 36474831 · DOI 10.1177/15357597221086111
  7. MRI Guided Focused Ultrasound-Mediated Delivery of Therapeutic Cells to the Brain: A Review of the State-of-the-Art Methodology and Future Applications.
    Ahmed N, Gandhi D, Melhem ER, Frenkel V. · · 2021 · cited 18× · PMID 34220679 · DOI 10.3389/fneur.2021.669449
  8. Targeted manipulation of pain neural networks: The potential of focused ultrasound for treatment of chronic pain.
    Todd N, McDannold N, Borsook D. · · 2020 · cited 13× · PMID 32534900 · DOI 10.1016/j.neubiorev.2020.06.007

Verify or expand the search:

Other recruiting trials for Epilepsy

Currently open trials in the same condition.

Other InSightec trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02804230.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing