Recruiting NCT07680842
Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Target optimization using LIFU, Serial LIFU stimulation.
- Who it may be relevant to
- Registry conditions: Drug-Resistant Epilepsy, Epilepsy, Epilepsy (Treatment Refractory), Epilepsy Comorbidities. Basic parameters: 21 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pilot Study of Non-Invasive Low Intensity Focused Ultrasound as an Adjunctive Treatment for Drug-Resistant Epilepsy
Overview
The goal of this study is to investigate the effects of a non-invasive, low intensity focused ultrasound (LIFU) stimulation on seizure frequency and the epileptogenic network in drug-resistant epilepsy. LIFU uses focused sound waves to modulate deep brain regions and to enable changes in brain network activity. Encephalography (EEG) and behavioral tasks will also be used to study how LIFU affects brain activity.
Interventions
- Device Target optimization using LIFU
LIFU will be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Positioning is guided by an offline MRI scan, enabling non-invasive targeting of the LIFU beams directly to deep brain structures. Targeting will be determined based on the epileptogenic network. - Device Serial LIFU stimulation
Serial LIFU will again be administered using the ATTN201 wearable device by Attune Neurosciences Inc. Serial stimulation target selection will be based on the initial target optimization outcome, including the assessment of physiology and clinical treatment response.
Primary outcome measures
- Seizure Frequency [Time frame: Seizure counts will be obtained daily for at least 1 month prior to the first study visit, throughout the study which averages around 4 months, and monitored for up to 2 months after the final visit.]
Secondary outcome measures (2)
- LIFU induced network change based on fMRI and/or electrophysiology [Time frame: Obtained at the baseline visit and the final day of serial stimulation, which averages around 4 months.]
- Cognitive battery [Time frame: The cognitive battery will be performed at baseline visit, as well as at the beginning and end of routine study visits; the duration averages around a 4 month period.]
Eligibility criteria
Inclusion criteria
- Male or female between 21 and 65 years of age at screening
- Clinical diagnosis of drug-resistant epilepsy with on average, 4 or more seizures per month.
- Able to provide informed consent (or assent when applicable) by the subject or subject's legal representative.
- Be willing to undergo a brain MRI.
- Be able and willing to wear a headband during the treatment duration.
- Be able to complete scheduled visits and daily seizure logs.
Exclusion criteria
- Has a craniotomy or pathologic intracranial lesion (e.g. vascular malformations) in the trajectory of the focused ultrasound beam.
- Pregnant, breastfeeding, is attempting pregnancy, or unwilling to practice birth control during participation in the study.
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
- Has any unstable medical or psychiatric disease.
- Any contraindications for completing a brain MRI scan.
- Has evidence of any other clinically relevant neurological disorder at the time of screening, including Alzheimer's disease, frontotemporal dementia, Huntington's disease, amyotrophic lateral sclerosis, and multiple sclerosis.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Publications
- Fan JM, Woodworth K, Murphy KR, Hinkley L, Cohen JL, Yoshimura J, Choi I, Tremblay-McGaw AG, Mergenthaler J, Good CH, Pellionisz PA, Lee AM, Di Ianni T, Sugrue LP, Krystal AD. Thalamic transcranial ultrasound stimulation in treatment resistant depression. Brain Stimul. 2024 Sep-Oct;17(5):1001-1004. doi: 10.1016/j.brs.2024.08.006. Epub 2024 Aug 22. No abstract available. PMID 39173737
Identifiers
NCT: NCT07680842 · 24-41317