A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia (dTMS)
1 de setembro de 2026 atualizado por: Ping Shao, Second Xiangya Hospital of Central South University
The Study of Improving Antipsychotic-induced Appetite by Deep Transcranial Magnetic Stimulation: The Effects of Improving Antipsychotic-induced Appetite by Single Session dTMS After Food Cue-induced Craving, A Randomized, Crossover and Sham-Controlled Trail
Antipsychotic-induced metabolic disturbances, especially weight gain, are common in patients with schizophrenia.
Furthermore, it is reported significant changes in food intake happened in patients with weight gain after intaking antipsychotics.
There are no hitherto effective treatments for reducing antipsychotic-induced weight gain.
dTMS which is a safe and non-invasive physical treatment indicates greater efficacy than other transcranial magnetic stimulation (TMS) by some research.
Apart from that, symptom provocation is believed to improve the clinical responses to TMS.
In this study, the investigators, firstly, evaluate the safety and effectiveness of dTMS for reducing antipsychotic-induced weight gain and secondly, unveil whether symptom provocation can affect the clinical responses to TMS.
Visão geral do estudo
Status
Ainda não está recrutando
Descrição detalhada
The underlying causes of antipsychotic-induced weight gain are still unknown. Some research point out that it has something to do with metabolic disturbances and changes in appetite and food intake. With fMRI study, it is reported having dysfunction between prefrontal and insula cortex of its cognitive regulation, interoceptive signals and reward control. dTMS, H4 coil in particular, simultaneously targets prefrontal and insula cortex. Previous study has been deconstrued that dTMS could significantly improve weight gain. Moreover, it is reckoned that TMS has state-dependent effects on brain circuitry, suspected that symptom provocation may be made it more susceptible to modulation which may improve response. Therefore, this study is to explore the efficacy of dTMS on antipsychotic-induced appetite, and whether provoking symptoms can improve dTMS clinical responses.
With regard to investigate this, the investigators will be carried out a randomized single session dTMS, crossover, sham controlled clinical trial. 30 Patients with schizophrenia will be randomly treated with dTMS after food cue induced craving (FCC), dTMS without FCC and sham condition without FCC. Each session has three days intervals for washout. The follow-ups are at the baseline and after each session immediately. The main outcome measures include the change in Food-Cravings Questionnaires state (FCQ-S) score, Visual Analogue Scale (VAS) score, changes in Stop-Signal test (SST) behavioral assessment and the resting-state functional magnetic resonance imaging data.
Tipo de estudo
Intervencional
Inscrição (Estimado)
30
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: Ping Shao
- Número de telefone: +86-13755112445
- E-mail: shp97jw@163.com
Estude backup de contato
- Nome: Renrong Wu
- Número de telefone: +86-15874179855
- E-mail: wurenrong@csu.edu.cn
Locais de estudo
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Hunan
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Changsha, Hunan, China, 410011
- The Second Xiangya Hospital of Central South University
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Contato:
- KaHei Chan
- Número de telefone: +86-18890384723
- E-mail: heimradchan@foxmail.com
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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
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Aged between 18-60
- Meeting the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for schizophrenia, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5).
- Gaining body weight around 7% after intaking antipsychotics within 2 years
- Participants were on a stable medication regimen at the time of enrollment
- Written informed consent was obtained from both the participants and their legally authorized guardians
Exclusion Criteria:
- Participants who switch antipsychotic drugs (APDs) or require a dose modification exceeding 25% of the baseline dosage during the study period.
- Diagnosed with other mental diseases in accordance with DSM-V
- Comorbid with other severe physiological diseases
- Active suicidal ideation
- A history of alcohol or substance use disorder (or abuse)
- Presence of metal implants or any other conditions contraindicated for magnetic resonance imaging (MRI)
- Presence of intracranial metal or electronic devices, a personal or family history of epilepsy, or any other standard contraindications to deep transcranial magnetic stimulation
- Receipt of regular repetitive transcranial magnetic stimulation (rTMS), electroconvulsive therapy (ECT), or weight-loss interventions within the past month
- Pregnant or lactating women
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 cruzada
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Active dTMS after food cue induced craving (dTMS+FCC)
Participants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after food cue induced craving by watching the personalized video based on each participant's favorite food choices
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The study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula and prefrontal cortex by Intermittent theta burst stimulation (iTBS).
The stimulation intensity is set at 90% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
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Comparador Ativo: Active dTMS after non food cue induced craving (dTMS+NON FCC)
Participants will receive single session of active-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
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The study will utilize the H4 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the bilateral insula and prefrontal cortex by Intermittent theta burst stimulation (iTBS).
The stimulation intensity is set at 90% of resting motor threshold (RMT), and the other parameters are set to triplet 50Hz bursts, repeat at 5Hz, 2s seconds on and 8 seconds off, 1800 pulses per session, total duration of 9 minutes and 52 seconds.
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Comparador Falso: Sham dTMS after non food cue induced craving (SHAM dTMS+NON FCC)
Participants will receive single session of sham-dTMS to the bilateral insula and prefrontal cortex with H4 coil after neural visual stimulation by watching non-food and non-food related video
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O estudo utilizará um protocolo idêntico usando a bobina H4 para administrar uma condição simulada.
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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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Food Craving Questionnaire State, FCQ-S
Prazo: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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The assessment of food cravings.
The FCQs consists of 15 items to be scored on a 5-point scale ranging from strongly disagree to strongly agree.
Its original form comprises five subscales measuring current food craving in relation to (1) an intense desire to eat, (2) anticipation of positive reinforcement, (3) relief from negative states, (4) lack of control over eating, and (5) hunger.
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Visual Analogue Scale, VAS
Prazo: Assessed at three time points (pre-provocation, immediately post-provocation [within 5 min], and immediately post-dTMS [within 30 min]) on Study Days 1, 5, and 9.
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The Visual Analogue Scales required the subjects to rate hunger, satiety, thirst, fullness and emptiness on a 0-100 mm scale.
The Visual Analogue Scales of Craving was assessed two times: before the provocation procedure, and after the provocation procedure
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Assessed at three time points (pre-provocation, immediately post-provocation [within 5 min], and immediately post-dTMS [within 30 min]) on Study Days 1, 5, and 9.
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Changes of Stop-Signal mean reaction time (SSRT)
Prazo: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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The SST aims to access cognitive behavioral inhibition control.
The study employed a task that comprised randomly interleaved NoGo and Stop-Signal trials to examine both types of inhibition.
The study measured six behavioral parameters of interest: namely Mean Go reaction time (GoRT), Stop-Signal mean reaction time (SSRT), Stop-Signal delay (SSD), Target accuracy, Go trial accuracy, and NoGo Accuracy.
The SST main outcome is the changes of Stop-Signal mean reaction time (SSRT)
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Resting-state functional magnetic resonance imaging
Prazo: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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All patients undergo head MRI scans in Philips Achieva 3.0 T scanner and SIEMENS Prisma 3.0 T scanner.
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Task-state functional magnetic resonance imaging
Prazo: Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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Measure of the immediate activation (blood-oxygen-level-dependent change) in the brain regions related to appetite neural circuits under food cue reactivity task
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Baseline (Day 1); immediately before and immediately after (within 30 minutes post-session) each daily dTMS session (Day 1, 5 and 9)
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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)
1 de setembro de 2026
Conclusão Primária (Estimado)
1 de maio de 2027
Conclusão do estudo (Estimado)
1 de junho de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
26 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
1 de setembro de 2026
Primeira postagem (Real)
8 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 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
- LYEC2026-0195
- 82571770 (Número de outro subsídio/financiamento: National Natural Science Foundation of China)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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