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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • Direct Electrical Stimulation

    Device

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

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Temporal Interference Stimulation to Epileptic FocusExperimental treatment 1 intervention
Group B: Temporal Interference Stimulation to ThalamusExperimental treatment 1 intervention
Group C: Direct Electrical StimulationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
2

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.

Time frame
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation

Secondary outcomes

1

High-frequency oscillations

The high-frequency oscillation rate per minute (frequency \>80 Hz) is an alternative biomarker of epilepsy. it is derived from sEEG macro- and microcontacts.

Time frame
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
2

local field potential spectral power

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.

Time frame
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation
3

Sleep microstructure

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

Time frame
20-minute baseline, 20-minute stimulation, 20-minute post-stimulation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

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