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Device
Focused Ultrasound for Seizures
N/A
Recruiting
Led By Imran Quraishi, MD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 10 minutes
Awards & highlights
No Placebo-Only Group
Summary
This trial studies a new treatment to reduce seizure activity in patients with Non-Convulsive or Focal Motor Status Epilepticus. It uses ultrasound to target brain areas.
Who is the study for?
This trial is for patients with ongoing non-convulsive or focal motor status epilepticus who haven't improved after two anti-seizure medications. They must be in the ICU, monitored by EEG, and have consent from a legal representative. It's not for those with cranial implants, pregnancy, metal in the head, recent other trials participation, or TENS unit use.
What is being tested?
The study tests Pulsed Low-Intensity Focused Ultrasound (PLIFU) on brain areas linked to seizures. The goal is to see if PLIFU can reduce seizure activity when standard treatments fail. Participants will undergo an initial 10-minute session of PLIFU with a possible second round if needed.
What are the potential side effects?
Potential side effects of PLIFU may include discomfort at the stimulation site, headache, or temporary changes in mood or cognition due to brain stimulation; however specific risks related to this treatment are still being evaluated.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 10 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 10 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in epileptiform activity
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Participants with ongoing non-convulsive or focal motor SEExperimental Treatment1 Intervention
Adult patients with ongoing non-convulsive or focal motor SE despite treatment with at least 2 ASMs and who are monitored with surface EEG will be screened and enrolled to receive up to 2 sessions of PLIFU.
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Who is running the clinical trial?
Swebilius FoundationUNKNOWN
Yale UniversityLead Sponsor
1,920 Previous Clinical Trials
3,031,473 Total Patients Enrolled
3 Trials studying Seizures
8,308 Patients Enrolled for Seizures
Imran Quraishi, MDPrincipal InvestigatorYale University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a device implanted in your brain to treat epilepsy.You are pregnant.You have metal objects in your head that can be affected by magnets.You have been diagnosed with persistent non-convulsive or focal motor seizures despite receiving treatment from two antiepileptic medications.You cannot participate if you have taken any experimental medication or undergone any experimental treatments within the last 24 hours.You have provided a signed and dated consent form authorized by your legal representative.You were admitted to the ICU and monitored with scalp EEG electrodes in a continuous manner.You currently use a TENS unit.
Research Study Groups:
This trial has the following groups:- Group 1: Participants with ongoing non-convulsive or focal motor SE
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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