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Purpose

The goal of this clinical trial is to learn how a non-invasive brain stimulation method called Temporally Interfering Electric Fields Stimulation (TIEFS) affects brain activity and thinking in adults. TIEFS uses electrical currents applied to the scalp to influence brain activity without surgery. The main questions this study aims to answer are: - How does TIEFS change brain signals measured with brain recordings? - Does TIEFS affect thinking abilities such as memory, language, movement, or perception? - Is TIEFS safe and well tolerated when used in people? This study includes two groups of participants. One group includes adults with epilepsy who are already undergoing specialized brain monitoring as part of their medical care. The other group includes healthy adults with no history of seizures. Participants will: - Receive brief sessions of TIEFS using electrodes placed on the scalp - Complete computer-based tasks that test memory, attention, language, or movement. Answer questions about how the stimulation feels - Have brain activity recorded during the study Each study visit lasts up to three hours and may occur in one or two sessions. Information from this study may help researchers better understand the human brain and support the development of future non-invasive brain stimulation treatments.

Condition

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Adult patients (age 18-65 years of age) undergoing an intracerebral electrophysiology study for epilepsy pre-surgical evaluation are eligible for inclusion. - For healthy control subjects are also eligible for inclusion (Scalp EEG measurements). - Participants must be able to sufficiently speak and understand English or Spanish for consent and be able to understand and complete cognitive tasks. - All subjects must have the ability to give valid informed consent.

Exclusion Criteria

  • No pregnant women will be recruited. - People with implanted electrical devices such as Deep Brain Stimulation devices or Pacemakers. - No prisoners will be recruited.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Basic Science
Masking
Single (Participant)
Masking Description
Participants are masked to the type of stimulation they receive. They are not told whether the stimulation delivered during a session is active or sham. Researchers and study staff are aware of the stimulation type, and no other parties are masked in this clinical trial.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Comparison of Active vs Sham TIEFS Stimulation in SEEG patients 		This arm involves a within-subject comparison of different frequencies of active TIEFS stimulation and sham stimulation, all within the same session. Patients will already have been admitted to SEEG surgery, and will be approached while still having the electrodes implanted. Each participant will receive multiple types of stimulation at different envelope frequencies (ranging from 1-130 Hz). During the session, electrodes will be placed on the scalp to administer TIEFS at varying frequencies. Each frequency will be tested in separate trials within the session, with multiple trials per frequency. The results from these trials will be averaged to determine the overall impact of each frequency on brain activity (measured through SEEG) and/or cognitive functions (evaluated using tasks related to memory, language, motor function, and perception). Sham stimulation will also be delivered within the same session, and participants will be blinded to the type of stimulation (active vs sham).
  • Device: Temporal Interference Electrical Stimulation
    Temporal Interference Electrical Stimulation (TIEFS) is a non-invasive brain stimulation technique that uses two high-frequency electrical fields (>1 kHz) to generate an interference pattern at a specific brain region, creating a low-frequency envelope (Δf = f2 - f1) at the target depth. Unlike traditional stimulation methods, which affect only superficial brain regions, TIEFS can reach deeper structures without the need for implanted electrodes. The stimulation is applied through scalp electrodes. It has the potential for targeted brain interventions in both functional studies and clinical applications for neurological conditions.
Experimental
Comparison of Active vs Sham TIEFS Stimulation in Healthy Subjects 		This arm involves a within-subject comparison of active and sham TIEFS stimulation in healthy control subjects. Participants will receive both active and sham stimulation in a single session, with different frequencies of TIEFS applied during active stimulation. The goal is to measure the changes in brain activity using EEG and assess the impact of TIEFS on cognitive functions such as memory, motor function, language, and perception. Participants will be blinded to the type of stimulation they are receiving during the session.
  • Device: Temporal Interference Electrical Stimulation
    Temporal Interference Electrical Stimulation (TIEFS) is a non-invasive brain stimulation technique that uses two high-frequency electrical fields (>1 kHz) to generate an interference pattern at a specific brain region, creating a low-frequency envelope (Δf = f2 - f1) at the target depth. Unlike traditional stimulation methods, which affect only superficial brain regions, TIEFS can reach deeper structures without the need for implanted electrodes. The stimulation is applied through scalp electrodes. It has the potential for targeted brain interventions in both functional studies and clinical applications for neurological conditions.

Recruiting Locations

University of California Davis Medical Center
Sacramento, California 95817
Contact:
Nigel P Pedersen, MBBS
617-462-8120
nppedersen@health.ucdavis.edu

More Details

Status
Recruiting
Sponsor
University of California, Davis

Study Contact

Nigel P Pedersen, MBBS
617-462-8120
nppedersen@health.ucdavis.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.