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NCT Number: NCT07663578

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

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.

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Nigel P Pedersen, MBBS

CONTACT

[email protected]

617-462-8120

Nigel P Pedersen, MBBS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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.

This outcome measures the changes in brain activity, either measured through scalp EEG electrodes (in Healthy Participant controls), or intracranial stereotaxic EEG electrodes (for SEEG pre-surgical evaluation epilepsy patients). Local field potential (LFP) power and EEG power in response to active TIEFS stimulation will be compared to sham stimulation. Electrical signals recorded from the brain reflect neural activity. Intracranial signals will be measured across different locations in the brain using implanted SEEG electrodes. Additionally, SEEG electrodes may have tetrodes tips to capture single neuron activity. We will compare how the brain's electrical activity changes during active TIEFS at various frequencies and during the sham stimulation to assess the impact on brain and neural function.

Study contacts

Contact information is provided by the study sponsor or research team.

Nigel P Pedersen, MBBS

CONTACT

[email protected]

617-462-8120

Raul S Castillo-Astorga, MD

CONTACT

[email protected]

530-220-0057

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Acronym: TIEFS

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Jun 23, 2026
Registry last updated: Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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