Cognitive and Electrophysiological Assessment of Non-Invasive Temporally-Interfering Electric Fields Stimulation (TIEFS)

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07663578
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Temporal Interference Electrical Stimulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Jun 2026
Primary completion
Apr 15, 2027
Completion
Apr 15, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • 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).
  • 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.

Primary Outcome Measure

Brain activity changes during Stimulation [ Time Frame: Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California Davis Medical CenterSacramentoCalifornia95817
Nigel P Pedersen, MBBS
[email protected]
617-462-8120
Nigel P Pedersen, MBBS (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Epilepsy
By specialty
NeurologyBrain disorders
By research site
University of California Davis Medical Center· Sacramento, CA

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