Epilepsy Trial, Recruiting NCT03868293 Sponsor: Brigham and Women's Hospital Condition: Epilepsy
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Epilepsy Trial, Recruiting

NCT03868293
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are at least 18 years old
  • People who have temporal lobe epilepsy that has not been controlled by at least two different anti-seizure medications, as confirmed by a specialist neurologist at Brigham and Women's Hospital
  • People who have at least 1 to 2 seizures per month on average, and who either know when their own seizures happen or have a reliable caregiver who does, and can keep a record of seizure frequency
  • People who have the mental ability to read and understand a consent form and can describe any symptoms they experience during or after treatments

Who may not be able to join:

  • People with a cognitive or psychiatric condition that prevents them from giving informed consent or cooperating with testing
  • People with dementia, another progressive brain disease, delirium, or active psychosis
  • People who have metal fragments or magnetic materials in their head
  • People with severe heart disease, raised pressure in the skull, or who use a TENS (nerve stimulation) device
  • People whose epilepsy is of the "primary generalised" type, or whose seizures are not actually epileptic in origin
  • People who have had a prolonged, uncontrolled seizure episode (status epilepticus) in the 3 months before joining the study
  • Women who are pregnant, or who are able to become pregnant and are not willing to use reliable contraception during the treatment period
  • People who are unable to have a brain MRI scan for any reason, such as having metal implants in the body or being unable to lie still
  • People who currently have a brain tumour or an abnormal blood vessel in the brain
  • People with serious, uncontrolled medical conditions such as diabetes, high blood pressure, lung disease, heart failure, or coronary artery disease, or any other condition that could pose a health risk during participation
  • People who have holes or gaps in the skull in the area where treatment would be given, due to injury or previous surgery
  • People with implanted devices such as pacemakers, medication pumps, or other electronic implants (note: people with a Vagal Nerve Stimulator may still be considered, as the device would be turned off before each treatment session and turned back on afterwards — confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Ellen J Bubrick, MD, Brigham and Women's Hospital

Phone: 617-732-7432

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
7 February 2019
Est. completion
9 March 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Patient tolerability of moderate term, repeated exposure toPulsed Low-Intensity Focused Ultrasound (PLIFUS) (Adverse Events assessment); Efficacy of PLIFUS in reducing seizure frequency; Effect of PLIFUS on patient EEG (evaluate number of attenuated epileptiform discharges)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov