Efficacy and Mechanism of Transcranial Temporal Interference Stimulation (tTIS) for Patients With Obsessive-Compulsive Disorders
1 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
80
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Xiang-yang Zhang
- Número de telefone: 18513299860
- E-mail: zhangxy99@mail.tsinghua.edu.cn
Locais de estudo
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Anhui
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Hefei, Anhui, China, 230000
- Recrutamento
- The Fourth People's Hospital of Anhui Province
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Contato:
- Zhang Xiang-yang
- Número de telefone: 18513299860
- E-mail: zhangxy99@mail.tsinghua.edu.cn
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Contato:
- E-mail: 18981248677@163.com
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Investigador principal:
- Xinyue Zhang
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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.
Outros nomes:
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Comparador Falso: 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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Obsessive-compulsive symptoms
Prazo: Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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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.
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Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Self-reported obsessive-compulsive symptoms
Prazo: Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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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.
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Baseline, immediately after completion of the 5-day intervention (Day 5), and at 1-week, 1-month, and 3-month follow-up
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Multimodal MRI measures
Prazo: Baseline, after completion of 5-day intervention
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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).
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Baseline, after completion of 5-day intervention
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Resting-state electroencephalography (EEG) measures
Prazo: Baseline, after completion of 5-day intervention
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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.
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Baseline, after completion of 5-day intervention
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Behavioral task performance
Prazo: Baseline, after completion of the 5-day intervention
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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.
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Baseline, after completion of the 5-day intervention
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
16 de outubro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
1 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de setembro de 2026
Primeira postagem (Real)
4 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
1 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ThuPsy-202608
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
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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