Overnight Temporal Interference Stimulation for Temporal Lobe Epilepsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with drug-resistant temporal lobe epilepsy undergo in-lab overnight sleep monitoring with EEG while receiving several nights of TI stimulation targeting both hippocampi. Each participant experiences nights without stimulation, nights with active stimulation, and a follow-up night after stimulation to see if any changes persist. The study compares EEG seizure activity and sleep quality during stimulated versus non-stimulated nights. Researchers also collect brief cognitive questionnaires and memory tasks to explore effects on thinking and memory. The approach uses non-invasive brain stimulation in a tightly controlled overnight setting at a single Duke-led site with international collaboration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 - 70 years
* Diagnosis of focal drug-resistant temporal lobe epilepsy
* Candidate for in-laboratory overnight monitoring with PSG and scalp EEG, with ability to comply with study procedures
* Stable antiseizure medication regimen for at least 1 week prior to admission
* Capacity to provide consent

Exclusion Criteria:

* Generalized epilepsy syndromes or primary generalized seizures
* Recent status epilepticus, seizure clusters requiring emergency intervention, or other features indicating unacceptable risk for monitored participation
* Uncontrolled psychiatric illness (e.g., acute psychosis, severe untreated depression with high suicide risk)
* Implanted electronic or metallic devices incompatible with TI (e.g., certain pacemakers, cochlear implants) as per device manual
* Severe obstructive sleep apnea requiring immediate CPAP initiation and not yet treated
* Dermatologic disease at electrode sites or known contact allergy to electrode materials
* Pregnancy or breastfeeding
* Concurrent enrollment in other interventional neuromodulation or pharmacological trials likely to confound EEG or sleep outcomes

Where it's running

• Anphy Lab - Inside Hock Plaza
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Birgit Frauscher, MD / PD — Duke University
• Study coordinator: Birgit Frauscher, MD, PhD
• Email: birgit.frauscher@duke.edu
• Phone: 919-613-9386

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Modified ketogenic diet for adults with drug-resistant epilepsy

  This study tests whether a modified ketogenic diet can help adults with drug-resistant epilepsy see fewer seizures and feel better overall.

  Recruiting Karolinska Institutet · Stockholm · NCT07878104

• Non-Invasive Low Intensity Focused Ultrasound Stimulation for Drug-Resistant Epilepsy

  This study tests whether low intensity focused ultrasound can help reduce seizures in adults with drug‑resistant epilepsy.

  Recruiting University of California, San Francisco · San Francisco, California · NCT07680842

• iVEAcare Neuromodulation System for drug‑resistant epilepsy: a feasibility look

  This study tests whether the iVEAcare neuromodulation system is safe and can help reduce seizures and improve quality of life in people with drug‑resistant epilepsy.

  Recruiting at 7 sites iVEAcare · Herston, Queensland and 6 other locations · NCT07640191

• Real-world use of the OneRF Ablation System for epilepsy

  This registry collects real-world outcomes and device performance from patients with drug-resistant epilepsy who are treated with SEEG-guided RF ablation using the OneRF system.

  Recruiting at 3 sites NeuroOne Medical Technologies Corporation · Miami, Florida and 2 other locations · NCT07546253

• Biomarkers of Response to SEEG Thermocoagulation

  This study tests biomarkers to see if they predict how well SEEG-guided radiofrequency thermocoagulation helps people with drug-resistant focal epilepsy.

  Recruiting Assistance Publique Hopitaux De Marseille · Marseille · NCT07399327

• Infrared light therapy hat for adults with drug-resistant epilepsy

  This will try an infrared red-light therapy hat in adults with drug-resistant epilepsy to see if it reduces seizures and is comfortable to wear.

  Recruiting Beth Israel Deaconess Medical Center · Boston, Massachusetts · NCT07145489

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.