Cognitive and Electrophysiological Assessment of Non-Invasive Temporally-Interfering Electric Fields Stimulation (TIEFS)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Temporal Interference Electrical Stimulation.
- Who it may be relevant to
- Registry conditions: Epilepsy. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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 electro
Primary outcome measures
- 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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 1 center
- University of California Davis Medical Center — Sacramento
Identifiers
NCT: NCT07663578 · 2226959