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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07805200
Enrollment
80
Registered
2026-09-04
Start date
2026-10-16
Completion date
2027-12-31
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive - Compulsive Disorder

Keywords

Transcranial temporal interference stimulation, Mental Disorders

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

Beijing HuiLongGuan Hospital
Lead SponsorOTHER
Tsinghua University
CollaboratorOTHER
The First People's Hospital of Hefei
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Obsessive-compulsive symptomsBaseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-upObsessive-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.

Secondary

MeasureTime frameDescription
Self-reported obsessive-compulsive symptomsBaseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-upThe 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.
Multimodal MRI measuresBaseline, after completion of 5-day interventionMultimodal 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).
Resting-state electroencephalography (EEG) measuresBaseline, after completion of 5-day interventionResting-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.
Behavioral task performanceBaseline, after completion of the 5-day interventionBehavioral 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.

Countries

China

Contacts

CONTACTXiang-yang Zhang
zhangxy99@mail.tsinghua.edu.cn18513299860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026