Cognitive and Electrophysiological Assessment of Non-Invasive Temporally-Interfering Electric Fields Stimulation (TIEFS) (TIEFS)
16. Juni 2026 aktualisiert von: University of California, Davis
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.
Studienübersicht
Status
Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
15
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Nigel P Pedersen, MBBS
- Telefonnummer: 617-462-8120
- E-Mail: nppedersen@health.ucdavis.edu
Studieren Sie die Kontaktsicherung
- Name: Raul S Castillo-Astorga, MD
- Telefonnummer: 530-220-0057
- E-Mail: rcastilloastorga@ucdavis.edu
Studienorte
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California
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Sacramento, California, Vereinigte Staaten, 95817
- Rekrutierung
- University of California Davis Medical Center
-
Kontakt:
- Nigel P Pedersen, MBBS
- Telefonnummer: 617-462-8120
- E-Mail: nppedersen@health.ucdavis.edu
-
Hauptermittler:
- Nigel P Pedersen, MBBS
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Grundlegende Wissenschaft
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Sequenzielle Zuweisung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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).
|
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.
|
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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.
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Brain activity changes during Stimulation
Zeitfenster: Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation.
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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.
|
Measurements will be recorded throughout the stimulation session (lasting up to 90 minutes), with data collected before, during, and immediately after each stimulation.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Nigel P Pedersen, MBBS, University of California Davis, School of Medicine, Neurology Department
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
16. April 2025
Primärer Abschluss (Geschätzt)
15. April 2027
Studienabschluss (Geschätzt)
15. April 2027
Studienanmeldedaten
Zuerst eingereicht
16. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
16. Juni 2026
Zuerst gepostet (Tatsächlich)
23. Juni 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
23. Juni 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Juni 2026
Zuletzt verifiziert
1. Juni 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2226959
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Upon publication, anonymized individual participant data (IPD) will be shared as part of the supplementary materials.
The shared data will include EEG recordings, cognitive task results (memory, language, motor, perception), and stimulation parameters (active vs sham, frequencies).
All IPD will be de-identified, with personal identifiers removed to ensure confidentiality and compliance with HIPAA.
The de-identified data will be made available through a repository or data-sharing platform, accessible to qualified researchers for scientific and educational use only.
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Nein
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