Closed-loop TBS Targeting rPO for the Core Clinical Features of the Methamphetamine Use Disorder
A Pilot Single-Arm Study of Closed-Loop TBS Theta-Burst Stimulation Targeting the Right Parietal-Occipital Cortex for Core Clinical Features of Methamphetamine Use Disorder
The goal of this clinical trial is to evaluate whether closed-loop theta-burst stimulation (TBS) targeting the right parietal-occipital cortex (rPO) can improve core clinical symptoms in individuals with methamphetamine use disorder (MUD), such as cue-reactivity and impaired inhibitory control.
The main questions it aims to answer are:
Can closed-loop rPO-TBS significantly reduce cue-reactivity, as measured by a Visual Analog Scale (VAS) and a cue-reactivity task? Does closed-loop stimulation enhance cognitive control, assessed by performance on the Stop Signal Task (SST)?
Researchers will administer closed loop TBS to determine whether it can improve the core symptoms of MUD.
Participants will:
Complete a single closed-loop sessions. Receive theta-burst stimulation targeting the right parietal-occipital cortex while complete the cue-reactivity task.
Undergo cue-reactivity assessment using a Visual Analog Scale (VAS) and complete the Stop Signal Task (SST) before and after the stimulation session.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Min Zhao, PhD
- Numéro de téléphone: +86 18017311005
- E-mail: drminzhao@smhc.org.cn
Lieux d'étude
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Chine, 200000
- Shanghai Mental Health Center, 200030
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Contact:
- Min Zhao, PhD
- Numéro de téléphone: 18017311005
- E-mail: drminzhao@smhc.org.cn
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Aged 18 years old or older, ....with at least 9 years of education (junior high school or above) or able to fully understand the task.
- Meets DSM-5 for mild/severe amphetamine-type substance use disorder.
- History of amphetamine-type substance use for no less than 1 year, with use at least once per week.
- Has not received pharmacological treatment for substance use.
Exclusion Criteria:
- Presence of any organic disease, or diagnosis of any other psychiatric disorder according to DSM-5 (e.g., bipolar disorder, major depression disorder).
- Contraindications to TMS, as assessed by the Transcranial Magnetic Stimulation Adult Safety Screen (TASS).
- Inability to complete assessments, treatment procedures, or follow-up due to cognitive or behavioral limitations.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Closed-loop Group
Before stimulation: The researchers measure the participant's Resting Motor Threshold (RMT) and assess their craving using VAS before and after view a methamphetamine-related video. The participants complete SST. During the stimulation phase, participants will: First undergo a training phase, during which EEG will be recorded while they perform a cue-reactivity task to identify neural signatures and calculate stimulation thresholds. Then perform the cue-reactivity task again, and real-time EEG features will be used to trigger TMS in a closed-loop mode. After the stimulation, participants will: The researchers again assess their craving using VAS before and after viewing a methamphetamine-related video. The participants again complete the SST. The researchers record adverse reactions and adverse events, and evaluate the blinding effect, through a Blinding Assessment Questionnaire. |
Participants receive theta-burst stimulation (TBS) over the right parietal-occipital cortex (rPO), triggered by real time by EEG signals recorded during a cue-reactivity task.
This closed-loop protocol aims to deliver stimulation precisely during neural states associated with cue-induced reactivity.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cue-Induced Neural Reactivity During Before and After Stimulation
Délai: During cue-reactivity task in training and stimulation phases of each session.
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EEG signals will be recorded while participants perform a cue-reactivity task during both the training phase (no stimulation) and the stimulation phase (with TBS).
The primary outcome will be changes in cue-induced neural reactivity, defined by EEG features such as event-related potentials (ERPs) and power spectral density (e.g., theta or alpha power) in response to methamphetamine-related cues.
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During cue-reactivity task in training and stimulation phases of each session.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Cue-Induced Craving Measured by Visual Analog Scale (VAS)
Délai: Before and within 30 minutes after stimulation
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Participants will rate their craving levels after viewing methamphetamine-related videos using a Visual Analog Scale (VAS), ranging from 0 (no craving) to 100 (maximum craving).
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Before and within 30 minutes after stimulation
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Change in Inhibitory Control Assessed by Stop Signal Task (SST)
Délai: Before and within 30 minutes after stimulation
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Participants will complete the Stop Signal Task (SST) before and after each stimulation session.
Measures such as Stop Signal Reaction Time (SSRT) and accuracy will be used to assess changes in inhibitory control performance.
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Before and within 30 minutes after stimulation
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MZhao-030
Informations sur les médicaments et les dispositifs, documents d'étude
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