Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring

NCT07764718 | Not Yet Recruiting FDA Device

• 2 other identifiers: PRO001197761R56NS148323-01
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates whether a non-invasive brain stimulation technique called Temporal Interference (TI) can reduce epilepsy-related abnormal brain activity and influence sleep-related brain rhythms in adults with focal drug-resistant epilepsy undergoing stereo-EEG monitoring for clinical care. Up to 30 participants will complete stimulation sessions during wakefulness and, when possible, natural non-REM sleep. Brain activity will be recorded using scalp EEG and implanted sEEG electrodes before, during, and after TI stimulation. Some participants may also receive subthreshold direct stimulation through implanted electrodes for comparison. The study aims to determine whether TI can reduce epilepsy biomarkers, alter sleep-related brain activity, and compare favorably with conventional direct electrical stimulation while remaining within established safety limits.

Conditions

Drug-Resistant Focal Epilepsy

Keywords

Drug-Resistant Epilepsy; Temporal Interference Stimulation; Stereo-EEG

Outcome Measures

Primary Outcomes (2)

• Interictal epileptiform discharge rate

  The interictal epileptiform discharge (IED) rate per minute is a classical biomarker of epilepsy. It is derived from sEEG macro- and microcontacts.

  20-minute baseline, 20-minute stimulation, 20-minute post-stimulation

• Single-unit firing rate

  single unit firing rate is the number of action potentials ("spikes") that an isolated neuron emits per second. It is derived from sEEG microcontacts.

  20-minute baseline, 20-minute stimulation, 20-minute post-stimulation

Secondary Outcomes (3)

• High-frequency oscillations

  20-minute baseline, 20-minute stimulation, 20-minute post-stimulation

• local field potential spectral power

  20-minute baseline, 20-minute stimulation, 20-minute post-stimulation

• Sleep microstructure

  20-minute baseline, 20-minute stimulation, 20-minute post-stimulation

Study Arms (3)

Temporal Interference Stimulation to Epileptic Focus

EXPERIMENTAL

Temporal Interference stimulation delivered through scalp electrodes targeting the epileptic focus during wakefulness and/or natural NREM sleep.

Device: Temporal Interference Stimulation

Temporal Interference Stimulation to Thalamus

EXPERIMENTAL

Temporal Interference stimulation delivered through scalp electrodes targeting the thalamus during wakefulness and/or natural NREM sleep.

Device: Temporal Interference Stimulation

Direct Electrical Stimulation

ACTIVE COMPARATOR

Subthreshold direct electrical stimulation delivered through implanted sEEG contacts.

Device: Direct Electrical Stimulation

Interventions

Temporal Interference Stimulation DEVICE

Non-invasive electrical stimulation delivered through scalp electrodes using paired sinusoidal currents with differential carrier frequencies to create a low-frequency envelope targeting deep brain structures including the epileptic focus or thalamus.

Temporal Interference Stimulation to Epileptic Focus; Temporal Interference Stimulation to Thalamus

Direct Electrical Stimulation DEVICE

Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.

Direct Electrical Stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Remote resective/ablative brain surgery

Sponsors & Collaborators

• Duke University: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

MeSH Terms

Conditions

Drug Resistant Epilepsy

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Birgit Frauscher

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): August 14, 2031
• Study Completion (Estimated): August 14, 2031
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR, ANALYTIC CODE
• Time Frame: IPD will be shared upon their initial online publication or 1-year following the end of the project.
• Access Criteria: Data Archive for the BRAIN Initiative (DABI)