Temporal Interference Brain Stimulation for Adults With Drug-Resistant Epilepsy Undergoing Stereo-EEG Monitoring
August 10, 2026 updated by: Duke University
Temporally Interfering Electric Field Stimulation in the Treatment of Epilepsy - Effect of Temporal Interference on Biomarkers of Epilepsy
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Temporal Interference Stimulation to Epileptic Focus
Temporal Interference stimulation delivered through scalp electrodes targeting the epileptic focus during wakefulness and/or natural NREM sleep.
|
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.
|
|
Experimental: Temporal Interference Stimulation to Thalamus
Temporal Interference stimulation delivered through scalp electrodes targeting the thalamus during wakefulness and/or natural NREM sleep.
|
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.
|
|
Active Comparator: Direct Electrical Stimulation
Subthreshold direct electrical stimulation delivered through implanted sEEG contacts.
|
Subthreshold biphasic electrical stimulation delivered through implanted stereo-EEG contacts, remaining below thresholds for after-discharges and perceptual sensations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interictal epileptiform discharge rate
Time Frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
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
Time Frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
High-frequency oscillations
Time Frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
The high-frequency oscillation rate per minute (frequency >80 Hz) is an alternative biomarker of epilepsy.
it is derived from sEEG macro- and microcontacts.
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
|
local field potential spectral power
Time Frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
The power of local field potentials in defined frequency bands (theta: 4-8 Hz, beta: 13-30 Hz, gamma: 30-100 Hz) will be measured from macro- and microcontacts.
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
|
Sleep microstructure
Time Frame: 20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
Sleep microstructure is comprised of sleep spindles (sleep specific transients of 10-16 Hz exceeding 0.5 seconds) and slow oscillations (delta wave transients < 0.5 Hz) measured in scalp EEG and sEEG macrocontacts.
Rates are provided per minute
|
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Birgit Frauscher, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 15, 2026
Primary Completion (Estimated)
August 14, 2031
Study Completion (Estimated)
August 14, 2031
Study Registration Dates
First Submitted
August 10, 2026
First Submitted That Met QC Criteria
August 10, 2026
First Posted (Actual)
August 14, 2026
Study Record Updates
Last Update Posted (Actual)
August 14, 2026
Last Update Submitted That Met QC Criteria
August 10, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Epilepsy
- Drug Resistant Epilepsy
- Therapeutics
- Behavioral Disciplines and Activities
- Electric Stimulation Therapy
- Convulsive Therapy
- Psychiatric Somatic Therapies
- Electroshock
- Psychological Techniques
- Transcranial Direct Current Stimulation
Other Study ID Numbers
- PRO00119776
- 1R56NS148323-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Annotated preprocessed datasets and final research data will be shared.
IPD Sharing Time Frame
IPD will be shared upon their initial online publication or 1-year following the end of the project.
IPD Sharing Access Criteria
Data Archive for the BRAIN Initiative (DABI)
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.