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Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3

8 settembre 2026 aggiornato da: Joshua Brown, PHD, Indiana University

Temporal Interference Methods for Non-invasive Deep Brain Stimulation

This grant aims to develop a line of research using temporal interference (TI) electrical neurostimulation technology to understand the causal role of deep brain structures in cognition. In the short term, the investigators aim to validate and characterize the effects of TI on brain activity as measured by fMRI and demonstrate its ability to focally stimulate deep brain regions without affecting overlying cortex. In the longer term, investigators aim to use these data to resolve longstanding debates about the function of deeper brain regions and lay the foundation for future clinical applications of TI for treating addiction, Obsessive-Compulsive Disorder (OCD), Parkinson's disease, and other disorders involving deep brain dysfunction. The grant supports 2 distinct aims, each of which will be evaluated through a series of independent studies.

Panoramica dello studio

Descrizione dettagliata

Through the grant's duration, the investigators hypothesize that temporal interference (TI) electrical neurostimulation will be well tolerated and effective at focally manipulating deep brain activity as measured by functional MRI (fMRI) BOLD signals. The investigators will investigate whether TI stimulation can increase BOLD activity in targeted deep brain regions including the nucleus accumbens (NAcc) and dorsal anterior cingulate cortex (dACC), and whether this stimulation can influence cognitive functions controlled by these regions. TI works by applying alternating currents of slightly different frequencies through multiple electrode pairs, creating an interference pattern that can stimulate deep brain regions without significantly affecting superficial cortical areas. This method is similar to traditional transcranial direct current stimulation (tDCS), however TI can stimulate deeper brain structures that tDCS cannot reach effectively. The study is broken up into two main aims with multiple sub-studies. In Aim 1, the investigators will characterize the effects of TI on fMRI BOLD signals, test different beat frequencies, and compare TI effects in the nucleus accumbens versus dorsal anterior cingulate cortex. In Aim 2, the investigators will apply TI to the dorsal anterior cingulate cortex to test causal theories about its role in cognitive control, conflict monitoring, risk avoidance, and foraging behavior using established cognitive tasks while subjects undergo fMRI scanning.

Study 1.3 (Aim 1, Study 1.3) will test whether TI can focally modulate activity in the dorsal anterior cingulate cortex, around MNI coordinates 0, 30, 30, as measured by fMRI BOLD signal. Healthy subjects (n=30) will complete a single study visit during which they will undergo fMRI while receiving TI stimulation through carbon fiber electrodes attached to the scalp with conductive gel. Electrode placement may vary by participant to optimize dACC targeting using individualized finite element modeling.

Participants will receive active and sham TI stimulation at a selected beat frequency potentially including 5 Hz, 30 Hz, 40 Hz, or another frequency in the 1-100 Hz range. Stimulation will follow an on/off sequence of 2 minutes on, 2 minutes off, 2 minutes on, and 2 minutes off, with 30-second ramp up and ramp down periods beginning at the start of each 2-minute stimulation period. Study 1.3 will also examine whether increased stimulation intensity improves modulation of BOLD activity in the dACC. Stimulation may be delivered up to ±5 mA per channel, corresponding to 10 mA peak-to-peak, with the second stimulation channel linearly scaled based on individualized modeling to maintain optimal targeting. Active and sham stimulation blocks will be counterbalanced across subjects.

Tipo di studio

Interventistico

Iscrizione (Stimato)

30

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Joshua W Brown, PhD
  • Numero di telefono: 812-855-9282
  • Email: cclab@iu.edu

Backup dei contatti dello studio

  • Nome: Irene Jang, BS
  • Numero di telefono: 812-856-1846
  • Email: cclabmgr@iu.edu

Luoghi di studio

    • Indiana
      • Bloomington, Indiana, Stati Uniti, 47408
        • Reclutamento
        • Indiana University Bloomington, Imaging Research Facility
        • Contatto:
          • Josh W Brown, PhD
          • Numero di telefono: 812-856-1846
          • Email: cclab@iu.edu
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Between the ages of 18 and 50
  • Must have at least a 6th grade education
  • Ability to speak and read English for all phases

Exclusion Criteria:

  • Currently taking psychotropic medications for ADHD, other mental illness, or medications for cancer
  • History of epilepsy or seizure disorders
  • History of migraines or other neurological syndromes
  • History of AIDS (due to potential cognitive deficits)
  • History of head trauma or cognitive impairments
  • Personal experiences consistent with symptoms of psychosis (e.g., hallucinations, delusions of control or special powers)
  • History of skull defects (e.g., holes bored into the skull or known cranial fissures)
  • Metal implants in the head or under the scalp
  • Does not meet fMRI safety screening criteria (e.g., metal implants in the body, permanent jewelry, tattoos on the head or neck)
  • Uses an intrauterine device (IUD) for birth control and cannot provide documentation to verify MRI safety
  • Pregnancy (self-reported; no pregnancy test administered)
  • Weight over 440 lbs (scanner weight limit)
  • Presence of pacemakers

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: dACC 20Hz Active then Sham; Comparison frequency Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using two pairs of carbon fiber electrodes in the following order: 20 Hz TI Active, 20 Hz TI Sham, selected comparison frequency TI Active, then selected comparison frequency TI Sham. The comparison frequency will be within the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Comparatore attivo: dACC 20Hz Sham then Active; Comparison Frequency Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: 20 Hz TI Sham, 20 Hz TI Active, selected comparison frequency TI Sham, then selected comparison frequency TI Active. The comparison frequency will be in the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Comparatore attivo: dACC Comparison Frequency Sham then Active; 20Hz Sham then Active
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Sham, selected comparison frequency TI Active, 20 Hz TI Sham, then 20 Hz TI Active. The comparison frequency will be in the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Comparatore attivo: dACC Comparison Frequency Active then Sham; 20Hz Active then Sham
Participants in this arm receive temporal interference (TI) electrical stimulation targeting the dorsal anterior cingulate cortex using scalp electrodes. The stimulation order is: selected comparison frequency TI Active, selected comparison frequency TI Sham, 20 Hz TI Active, then 20 Hz TI Sham. The comparison frequency will be in the 1-100 Hz range.
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC 20 Hz TI Active condition, one channel will deliver 2000 Hz and the other 2020 Hz, producing a 20 Hz beat frequency targeting the dorsal anterior cingulate cortex. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC 20 Hz TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies at up to ±5 mA per channel, corresponding to 10 mA peak-to-peak. For the dACC comparison frequency TI Active condition, stimulation will be delivered using a selected beat frequency in the 1-100 Hz range. Stimulation is administered in 2-minute on / 2-minute off cycles with a 30-second ramp up and ramp down beginning at the start of each 2-minute period.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI
Same setup as the dACC comparison frequency TI Active condition, except that stimulation immediately ramps down after reaching the target intensity following ramp up, producing a sham condition.
Altri nomi:
  • Neurostimolazione elettrica TI
  • Neurostimolazione TI

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in brain activity in the dorsal anterior cingulate cortex during 20 Hz versus selected comparison frequency temporal interference stimulation
Lasso di tempo: During fMRI scan on study day (approximately 60 minutes)
Brain activity in the dorsal anterior cingulate cortex will be measured using functional magnetic resonance imaging (fMRI) during temporal interference (TI) stimulation at 20 Hz compared to a selected comparison beat frequency. The comparison frequency will be in the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in neural activity. Higher BOLD values indicate stronger brain activation.
During fMRI scan on study day (approximately 60 minutes)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at 20 Hz
Lasso di tempo: During fMRI scan on study day (approximately 60 minutes)
Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at a 20 Hz beat frequency. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.
During fMRI scan on study day (approximately 60 minutes)
Change in brain activity in the dorsal anterior cingulate cortex during active versus sham stimulation at the selected comparison frequency
Lasso di tempo: During fMRI scan on study day (approximately 60 minutes)
Brain activity in the dorsal anterior cingulate cortex will be measured using fMRI during active versus sham temporal interference stimulation at the selected comparison beat frequency. The comparison frequency will be within the 1-100 Hz range. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal.
During fMRI scan on study day (approximately 60 minutes)
Change in brain connectivity between the dorsal anterior cingulate cortex and other brain regions during temporal interference stimulation
Lasso di tempo: During fMRI scan on study day (approximately 60 minutes)
Functional connectivity between the dorsal anterior cingulate cortex and other brain regions will be measured using fMRI-based analyses during active versus sham temporal interference stimulation. Higher correlation values indicate stronger communication between brain regions. The primary test statistic will be the whole-brain psychophysiological interaction (PPI) between dorsal anterior cingulate cortex BOLD activity and stimulation condition.
During fMRI scan on study day (approximately 60 minutes)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Joshua W Brown, PhD, Indiana University, Bloomington

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

16 luglio 2026

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

19 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 settembre 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 26941, Study 1.3
  • 1R21MH140210-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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