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

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.

Study Overview

• Status: Recruiting
• Conditions: Obsessive - Compulsive Disorder
• Intervention / Treatment: Device: Transcranial Temporal Interference Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiang-yang Zhang; Phone Number: 18513299860; Email: zhangxy99@mail.tsinghua.edu.cn

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230000
      • Recruiting
      • The Fourth People's Hospital of Anhui Province
      • Contact: Zhang Xiang-yang; Phone Number: 18513299860; Email: zhangxy99@mail.tsinghua.edu.cn
      • Contact: Email: 18981248677@163.com
      • Principal Investigator: Xinyue Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.; Other Names: 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.	Device: 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.; Other Names: tTIS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Obsessive-compulsive symptoms	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported obsessive-compulsive symptoms	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	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	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	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

Collaborators and Investigators

• Sponsor: Beijing HuiLongGuan Hospital
• Collaborators: Tsinghua University; The First People's Hospital of Hefei

Study record dates

Study Major Dates

• Study Start (Estimated): October 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Mental Disorders; Transcranial temporal interference stimulation
• Additional Relevant MeSH Terms: Personality Disorders; Mental Disorders; Compulsive Personality Disorder
• Other Study ID Numbers: ThuPsy-202608

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No