Epilepsy
Conditions
Keywords
Brain Stimulation
Brief 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.
Interventions
DEVICETemporal 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.
Sponsors
University of California, Davis
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain activity changes during Stimulation | 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. |
Countries
United States
Contacts
CONTACTNigel P Pedersen, MBBS
CONTACTRaul S Castillo-Astorga, MD
PRINCIPAL_INVESTIGATORNigel P Pedersen, MBBS
University of California Davis, School of Medicine, Neurology Department
Outcome results
None listed