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
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2026
CompletedFirst Posted
Study publicly available on registry
September 4, 2026
CompletedStudy Start
First participant enrolled
October 16, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
Study Completion
Last participant's last visit for all outcomes
December 31, 2027
September 4, 2026
September 1, 2026
1.2 years
September 1, 2026
September 1, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Self-reported obsessive-compulsive symptoms
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
Baseline, after completion of 5-day intervention
Resting-state electroencephalography (EEG) measures
Baseline, after completion of 5-day intervention
Behavioral task performance
Baseline, after completion of the 5-day intervention
Study Arms (2)
Nucleus accumbens group (tTIS)
EXPERIMENTALParticipants 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.
Control Group
SHAM COMPARATORParticipants 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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing HuiLongGuan Hospitallead
- Tsinghua Universitycollaborator
- The First People's Hospital of Hefeicollaborator
Study Sites (1)
The Fourth People's Hospital of Anhui Province
Hefei, Anhui, 230000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 1, 2026
First Posted
September 4, 2026
Study Start (Estimated)
October 16, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
September 4, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
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.