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Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) for Patients With Obsessive-Compulsive Disorders

1 september 2026 uppdaterad av: Xiang Yang Zhang, Beijing HuiLongGuan Hospital

Individualized Targeted Transcranial Temporal Interference Stimulation for for Patients With Obsessive-Compulsive Disorders: A Double-Blinded, Randomized Controlled Trial

Targeted temporal interference stimulation (tTIS) of the nucleus accumbens (NAc) may modulate the abnormal electrophysiological activity in individuals with obsessive-compulsive disorder (OCD), thereby improving their obsessive-compulsive symptoms.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This study will investigate the therapeutic effects and potential neural mechanisms of targeted temporal interference stimulation (tTIS) of the nucleus accumbens in individuals with obsessive-compulsive disorder (OCD). Participants will receive either active or sham tTIS for 5 consecutive days. Clinical symptoms will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS) and additional psychological questionnaires at baseline, immediately after the intervention, and during follow-up assessments. Behavioral tasks, including instrumental learning and probabilistic reversal learning paradigms, will be administered to assess intervention-related changes in behavioral performance. Resting-state electroencephalography (EEG) and multimodal magnetic resonance imaging (MRI) will be acquired before and after the intervention to evaluate intervention-related changes in brain function and structure. The study aims to evaluate the clinical efficacy of nucleus accumbens-targeted tTIS and to explore its potential behavioral and neurobiological mechanisms in OCD.

Studietyp

Interventionell

Inskrivning (Beräknad)

80

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • Were between 18 and 65 years old;
  • Were diagnosed with OCD by an experienced psychiatrist utilizing the Structured Clinical Interview for DSM-5 (SCID);
  • Were able to participate in the entire trial and face-to-face on-site assessment

Exclusion Criteria:

  • Pregnant or breastfeeding;
  • Suffered from organic brain diseases or severe physical illness;
  • Had a history of substance or alcohol abuse;
  • Presence of comorbid psychiatric disorders (e.g., major depressive disorder) or a high risk of suicide;
  • Have received electroconvulsive therapy, transcranial magnetic stimulation, tDCS, tACS, or other neurostimulation treatments within the past 6 months;
  • Presence of contraindications to MRI or tTIS, such as severe head trauma, prior brain surgery, intracranial or cardiac metallic implants, etc.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Nucleus accumbens group (tTIS)
Participants assigned to the active tTIS group will receive temporal interference stimulation targeting the right nucleus accumbens (NAc). Individualized electrode configurations will be determined based on each participant's structural MRI. Two high-frequency alternating currents at 2000 Hz and 2130 Hz will be applied, with a peak current intensity of up to 2 mA for each stimulation channel. Each stimulation session will last 30 minutes and will include a 30-second linear ramp-up at the beginning and a 30-second linear ramp-down at the end. Electrode impedance will be maintained below 8 kΩ. Stimulation will be administered twice daily for 5 consecutive days, with an interval of approximately 90-120 minutes between the two daily sessions.
Enhet: Transcranial Temporal Interference Stimulation
Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain. The physics of tTIS offers the advantage of noninvasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.
Andra namn:
  • ttis
Sham Comparator: Control Group
Participants assigned to the sham control group will undergo the same procedures and stimulation settings as those in the active tTIS group, including electrode placement, stimulation frequencies, nominal current intensity, ramp-up and ramp-down phases, session duration, and treatment schedule. However, no therapeutic stimulation current will be delivered.
Enhet: Transcranial Temporal Interference Stimulation
Transcranial temporal interference stimulation (tTIS) is a novel neurostimulation technique that utilizes two or more electric fields of specific frequencies to modulate the oscillations of neurons at the desired spatial location in the brain. The physics of tTIS offers the advantage of noninvasively regulating deep brain structures and minimally stimulating the overlying cortex outside the selected target.
Andra namn:
  • ttis

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Obsessive-compulsive symptoms
Tidsram: Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
Obsessive-compulsive symptom severity will be assessed using the Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS total score ranges from 0 to 40, with higher scores indicating greater symptom severity.
Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Self-reported obsessive-compulsive symptoms
Tidsram: Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
The reduction rate of the score of Obsessive-Compulsive Inventory-Revised (OCI-R), a self-rating scale of OCD symptoms severity, was employed as a secondary outcome.
Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
Multimodal MRI measures
Tidsram: Baseline, after completion of 5-day intervention
Multimodal MRI data will be acquired at baseline and after completion of the 5-day intervention using a 3.0-T MRI scanner. The imaging protocol includes T1-weighted and T2-weighted structural MRI, resting-state blood-oxygen-level-dependent (BOLD) functional MRI, and diffusion-weighted imaging (DWI).
Baseline, after completion of 5-day intervention
Resting-state electroencephalography (EEG) measures
Tidsram: Baseline, after completion of 5-day intervention
Resting-state EEG will be recorded at baseline and after completion of the 5-day intervention. Changes in EEG-derived neurophysiological measures between baseline and post-intervention will be assessed to characterize intervention-related alterations in brain activity.
Baseline, after completion of 5-day intervention
Behavioral task performance
Tidsram: Baseline, after completion of the 5-day intervention
Behavioral task performance will be assessed at baseline and after the 5-day intervention using computerized cognitive tasks. Task-derived behavioral measures, such as instrumental learning tasks and probabilistic reversal learning tasks, will be analyzed to evaluate intervention-related changes in behavioral performance.
Baseline, after completion of the 5-day intervention

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beijing HuiLongGuan Hospital

Samarbetspartners

Tsinghua University
The First People's Hospital of Hefei

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

16 oktober 2026

Primärt slutförande (Beräknad)

31 december 2027

Avslutad studie (Beräknad)

31 december 2027

Studieregistreringsdatum

Först inskickad

1 september 2026

Först inskickad som uppfyllde QC-kriterierna

1 september 2026

Första postat (Faktisk)

4 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • ThuPsy-202608

Plan för individuella deltagardata (IPD)

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JA

IPD-planbeskrivning

Deidentified individual participant data underlying the results reported in publications may be shared with qualified researchers upon reasonable request and approval by the principal investigator and relevant institutional authorities.

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