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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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.

Locations
United States
California
University of California Davis Medical Center
RECRUITING
Sacramento
Contact Information
Primary
Nigel P Pedersen, MBBS
nppedersen@health.ucdavis.edu
617-462-8120
Backup
Raul S Castillo-Astorga, MD
rcastilloastorga@ucdavis.edu
530-220-0057
Time Frame
Start Date: 2025-04-16
Estimated Completion Date: 2027-04-15
Participants
Target number of participants: 15
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of California, Davis

This content was sourced from clinicaltrials.gov