Last reviewed · How we verify
NCT02804230
MR-Guided Focused Ultrasound in the Treatment of Focal Epilepsy (EP001)
NA trial testing Neuro Ablation - Functional in Epilepsy in 20 participants. Status unknown.
23 June 2023
Quick facts
| Lead sponsor | InSightec |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 7 June 2016 |
| Primary completion | 23 June 2023 |
| Estimated completion | 30 June 2023 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Neuro Ablation - Functional
Conditions studied
- Epilepsy — all drugs for Epilepsy →
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):
-
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 -
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 -
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 -
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 -
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 -
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 -
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 -
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:
- PubMed search for NCT02804230
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
- NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
- NCT07224191 — Hippocampal Oscillations During Exploration · NA · recruiting
- NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07490769 — Levetiracetam Three Times Daily in Epilepsy · Phase 3 · recruiting
Other InSightec trials
Trials by the same sponsor.
- NCT04667715 — Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma · NA · withdrawn
- NCT05539196 — A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advance · recruiting
- NCT05089786 — Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001) · NA · unknown
- NCT05565443 — MR-guided Focused Ultrasound Plus GCase · NA · recruiting
- NCT05317858 — Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02804230 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by InSightec
- Last refreshed: 10 September 2022
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