A Relation Between Craving Induction and Treatment Response in Deep Transcranial Magnetic Stimulation (dTMS) for Reducing Antipsychotic-induced Weight Gain in Schizophrenia (dTMS)
1 settembre 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
30
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Ping Shao
- Numero di telefono: +86-13755112445
- Email: shp97jw@163.com
Backup dei contatti dello studio
- Nome: Renrong Wu
- Numero di telefono: +86-15874179855
- Email: wurenrong@csu.edu.cn
Luoghi di studio
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Hunan
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Changsha, Hunan, Cina, 410011
- The Second Xiangya Hospital of Central South University
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Contatto:
- KaHei Chan
- Numero di telefono: +86-18890384723
- Email: heimradchan@foxmail.com
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Comparatore attivo: 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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Comparatore fittizio: 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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Lo studio utilizzerà un protocollo identico utilizzando la bobina H4 per somministrare una condizione fittizia.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Food Craving Questionnaire State, FCQ-S
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Visual Analogue Scale, VAS
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 settembre 2026
Completamento primario (Stimato)
1 maggio 2027
Completamento dello studio (Stimato)
1 giugno 2027
Date di iscrizione allo studio
Primo inviato
26 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 settembre 2026
Primo Inserito (Effettivo)
8 settembre 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 settembre 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 settembre 2026
Ultimo verificato
1 settembre 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LYEC2026-0195
- 82571770 (Altro numero di sovvenzione/finanziamento: National Natural Science Foundation of China)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .