Temporal Interference Brain Stimulation for adults with drug-resistant focal epilepsy during stereo-EEG monitoring
Official title: Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy
Run by Duke University · NCT07764718 · Data updated 2026-11-12
This study tests whether a non-invasive Temporal Interference brain stimulation can reduce abnormal brain activity in adults with drug-resistant focal epilepsy who are undergoing stereo-EEG monitoring.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Status | Recruiting |
| Started | September 16, 2026 |
| Main results expected | August 14, 2031 |
| Study ends | August 14, 2031 |
| Registry record updated | October 15, 2026 |
| Trial ID | NCT07764718 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with drug-resistant focal epilepsy who are undergoing presurgical sEEG evaluation and have at least one thalamic sEEG electrode implanted for clinical purposes.
✕Probably not a fit
Patients without measurable focal epilepsy near the thalamic target or those unable to tolerate stimulation may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study uses Temporal Interference stimulation to modulate brain activity in adults with focal drug-resistant epilepsy who are already receiving stereo-EEG monitoring for presurgical evaluation. Participants may experience stimulation during wakefulness and, when possible, natural non-REM sleep, with brain signals recorded via scalp EEG and implanted sEEG electrodes before, during, and after stimulation. A subset may also receive subthreshold direct stimulation through implanted electrodes for comparison. The goal is to see if TI can reduce epilepsy biomarkers, affect sleep-related brain rhythms, and compare its effects to conventional direct electrical stimulation while staying within safety limits. Up to 30 participants are planned for this study.
Why it matters
Potential benefit: If successful, TI stimulation could offer a non-invasive option to modulate epileptic activity and potentially improve sleep-related brain patterns in drug-resistant epilepsy.
How similar studies have gone: Prior approaches using invasive electrical stimulation have shown seizure-modulating effects, but non-invasive TI methods in this specific presurgical, sEEG-guided context are exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients with focal DRE who will undergo presurgical evaluation with sEEG * Availability of at least one sEEG electrode inserted into the thalamus for clinical purposes * sEEG performed with the indication to identify one single epileptic focus * Ability to provide written informed consent and comply with the study protocol Exclusion Criteria: \- Remote resective/ablative brain surgery
Where it's running
-
Duke University Medical Center
Durham, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Birgit Frauscher — Duke University
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Impact of the brain’s adenosine pathway on epilepsy and arousal in adults
This study tests how the brain’s adenosine system affects arousal and breathing in adults with drug-resistant focal epilepsy compared with healthy volunteers.
-
Improving Medication Adherence for Recently Diagnosed Cancer Patients
This pilot tests whether a pharmacist-led program plus the Medisafe app helps people with newly diagnosed cancer who take multiple medicines stick to their treatment plans.
-
emPath platform pilot to link and keep adults with opioid use disorder in care in Durham
This pilot tests a mobile app and telemedicine approach to help adults with opioid use disorder start and stay in MOUD through community outreach in Durham, NC.
-
FlexED: A digital program to help young women see thoughts and feelings about their body in a friendlier way
This trial tests a smartphone-based, gamified ACT-inspired program called FlexED to help young women and girls at risk for eating disorders see how they think and feel about their bodies, and to see if it can be feasibly spread to more people.
-
Removing the ripcord from a glaucoma drainage device after 3 months
This study tests whether removing the ripcord from an implanted glaucoma drainage device changes eye pressure for adults with open-angle glaucoma.
-
Lupus Nephritis Care Pathway
A small group of adults with lupus nephritis will try a team-based care path that uses telemedicine and pharmacist-led support to help manage their treatment and see if it improves adherence and outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.