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Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.1 30 Non invasivo Breve termine

In arruolamento
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La sperimentazione clinica NCT07215299 è uno studio interventistico per Volontari sani, attualmente in arruolamento. Avviato il 12 novembre 2025, prevede di arruolare 30 partecipanti. Sotto la guida di l'Università dell'Indiana, dovrebbe concludersi entro il 2 febbraio 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 10 febbraio 2026.
Sommario breve
In its totality, 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 over...Mostra di più
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 an...Mostra di più
Titolo ufficiale

Temporal Interference Methods for Non-invasive Deep Brain Stimulation

Patologie
Volontari sani
Pubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:
Altri ID dello studio
Numero NCT
NCT07215299
Data di inizio (effettiva)
2025-11-12
Ultimo aggiornamento pubblicato
2026-02-10
Data di completamento (stimata)
2027-02-02
Arruolamento (previsto)
30
Tipo di studio
Interventistico
FASE
N.D.
Stato
In arruolamento
Parole chiave
Temporal Interference
fMRI
BOLD Signal
Cognitive Control
Dorsal Anterior Cingulate Cortex
Non-invasive deep brain stimulation
Neurostimulation
Scopo principale
Ricerca di base
Allocazione
Randomizzato
Modello di intervento
Studio incrociato
Mascheramento
Singolo
Bracci / Interventi
Gruppo/Braccio di partecipantiIntervento/Trattamento
Comparatore attivoNAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham
Participants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc TI Active, then NAcc TI Sham, then NAcc No-TI Active, then NAcc No-TI Sham.
Temporal Interference (TI) Electrical Stimulation - NAcc TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Active condition, 2000Hz will be administered in one channel a...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Sham condition, 2000Hz will be administered in one channel and...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Active condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles with a 30 second ramp up and ramp down beginning at the start of each 2 minute period.
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Sham condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles, however, instead of the 30 second ramp up and ramp down at the beginning of each 2 minute period (as seen in...Mostra di più
Comparatore attivoNAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham
Participants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc No-TI Active, then NAcc No-TI Sham, then NAcc TI Active, then NAcc TI Sham.
Temporal Interference (TI) Electrical Stimulation - NAcc TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Active condition, 2000Hz will be administered in one channel a...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Sham condition, 2000Hz will be administered in one channel and...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Active condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles with a 30 second ramp up and ramp down beginning at the start of each 2 minute period.
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Sham condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles, however, instead of the 30 second ramp up and ramp down at the beginning of each 2 minute period (as seen in...Mostra di più
Comparatore attivoNAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active
Participants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc TI Sham, then NAcc TI Active, then NAcc No-TI Sham, then NAcc No-TI Active.
Temporal Interference (TI) Electrical Stimulation - NAcc TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Active condition, 2000Hz will be administered in one channel a...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Sham condition, 2000Hz will be administered in one channel and...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Active condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles with a 30 second ramp up and ramp down beginning at the start of each 2 minute period.
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Sham condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles, however, instead of the 30 second ramp up and ramp down at the beginning of each 2 minute period (as seen in...Mostra di più
Comparatore attivoNAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active
Participants in this Arm receive temporal interference (TI) electrical stimulation with two pairs of carbon fiber electrodes in this order: NAcc No-TI Sham, then NAcc No-TI Active, then NAcc TI Sham, then NAcc TI Active.
Temporal Interference (TI) Electrical Stimulation - NAcc TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Active condition, 2000Hz will be administered in one channel a...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using alternating current frequencies (e.g., 2000 Hz and 2020 Hz) at up to 2 mA per electrode. This stimulation creates a beat frequency interference pattern (e.g., 20 Hz) that focally stimulates deep brain regions without activating overlying cortex. For the NAcc TI Sham condition, 2000Hz will be administered in one channel and...Mostra di più
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Active
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Active condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles with a 30 second ramp up and ramp down beginning at the start of each 2 minute period.
Temporal Interference (TI) Electrical Stimulation - NAcc No-TI Sham
Non-invasive electrical brain stimulation delivered through two sets of scalp electrodes using the same current frequencies at up to 2 mA per electrode. For the NAcc No-TI Sham condition, 2000Hz will be administered in both channels. These frequencies will be administered in 2 minutes on/2 minutes off cycles, however, instead of the 30 second ramp up and ramp down at the beginning of each 2 minute period (as seen in...Mostra di più
Esito primario
Misure di esitoDescrizione della misuraArco temporale
Change in brain activity in the nucleus accumbens during active versus sham stimulation
Brain activity in the nucleus accumbens will be measured using functional magnetic resonance imaging (fMRI) during active temporal interference (TI) brain stimulation compared to sham (placebo) stimulation. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in brain activity. Higher BOLD values indicate stronger brain activation.
During fMRI scan on study day (approximately 60 minutes)
Esito secondario
Misure di esitoDescrizione della misuraArco temporale
Change in brain activity in the nucleus accumbens during no-TI active versus no-TI sham high-frequency stimulation
Brain activity will be measured using fMRI when both electrode pairs deliver the same frequency (no-TI control). The percent change in BOLD signal during active versus sham high-frequency stimulation will be compared to determine whether high-frequency stimulation alone changes brain activity.
During fMRI scan on study day (approximately 60 minutes)
Change in brain activity in the nucleus accumbens during active TI stimulation versus active no-TI stimulation
Brain activity in the nucleus accumbens will be compared between active TI stimulation and active high-frequency (no-TI) stimulation. This comparison will show whether TI stimulation produces greater activation than high-frequency stimulation alone. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in brain activity. Higher BOLD values indicate stronger brain activation.
During fMRI scan on study day (approximately 60 minutes)
Change in brain connectivity between the nucleus accumbens and other brain regions during stimulation
Functional connectivity between the nucleus accumbens and other brain regions will be measured using fMRI-based analyses during active versus sham TI stimulation. Higher correlation values indicate stronger communication between brain regions. Activity will be reported as the percent change in blood-oxygen-level-dependent (BOLD) signal, which reflects changes in brain activity. Higher BOLD values indicate stronger brain activation. The test statistic will be the whole-brain interaction term of seed region BOLD activity multiplied by the condition of active vs. sham TI, more commonly known as a psycho-physiological interaction test.
During fMRI scan on study day (approximately 60 minutes)
Assistente alla partecipazione
Criteri di eleggibilità

Età idonea
Adulto
Età minima
18 Years
Sessi idonei
Tutti
Accetta volontari sani
Sì
  • Between the ages of 18 and 50
  • Must have at least a 6th grade education
  • Ability to speak and read English for all phases

  • 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
Indiana University logoUniversità dell'Indiana
National Institute of Mental Health (NIMH) logoNational Institute of Mental Health (NIMH)
Parte responsabile dello studio
Joshua Brown, PHD, Investigatore principale, Professor of Pyschological and Brain Science, Indiana University
Contatti principali dello studio
Contatto: Joshua W Brown, PhD, 812-855-9282, [email protected]
Contatto: Kendall E Moore, BS, 812-856-1846, [email protected]
1 Centri dello studio in 1 paesi

Indiana

Indiana University Bloomington, Imaging Research Facility, Bloomington, Indiana, 47408, United States
Josh W Brown, PhD, Contatto, 812-856-1846, [email protected]
Kendall E Moore, BS, Contatto, (812) 856-1846, [email protected]
In arruolamento