Closed-loop tTIS Targeted of the Nac as an Intervention for MUD Patients
31 de agosto de 2026 actualizado por: Shanghai Mental Health Center
Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients
Closed-loop transcranial temporal interference stimulation (tTIS) targeting the nucleus accumbens may modulate abnormal neural responses to drug-related cues in individuals with methamphetamine use disorder (MUD), thereby reducing drug craving and improving cognitive and behavioral control.
Stimulation will be delivered in real time according to each patient's cue-induced response time.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
This project will recruit individuals with methamphetamine use disorder. Participants will receive closed-loop transcranial temporal interference stimulation targeting the nucleus accumbens once daily for five consecutive days. During each intervention session, participants will be exposed to methamphetamine-related cues, and stimulation will be triggered according to their response time.
Before and after the intervention, clinical questionnaires and behavioral tasks will be administered to evaluate changes in drug craving, methamphetamine-use-related symptoms, inhibitory control, and reward-related decision-making. Cue-induced neural responses will also be assessed to investigate the neural mechanisms through which closed-loop tTIS targeting the nucleus accumbens may alleviate craving and improve addiction-related cognitive and behavioral dysfunction.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Min Zhao, PhD
- Número de teléfono: 64387250
- Correo electrónico: drminzhao@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Tianzhen Chen, PhD
- Correo electrónico: vomchan@hotmail.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200030
- Shanghai Mental Health Center
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Contacto:
- Min Zhao, Phd
- Número de teléfono: 64387250 18017311005
- Correo electrónico: drminzhao@smhc.org.cn
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education and capable of effectively cooperating in questionnaire evaluations.
- Meet the diagnostic criteria set forth by the DSM-V concerning the amphetamine-type substance addiction.
- A history of utilizing amphetamine-type substances for a duration not less than one year, with a frequency of use being at least once per week.
- Consent to actively cooperate in the completion of subsequent follow-up assessments.
Exclusion Criteria:
- Severe cognitive functional impairments manifested through a history of head trauma, cerebrovascular diseases, epilepsy, etc., or usage of cognitive enhancement drugs in the past 6 months; an intellectual disability with an IQ score less than 70.
- A diagnosis of schizophrenia or other severe mental illnesses as per the DSM-5 criteria.
- Abuse or dependence on other psychoactive substances (excluding nicotine) within the past 5 years.
- Severe organic diseases that might compromise study participation.
- Contraindications to cTBS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador falso: Grupo de control
Los parámetros de estimulación, incluidos la frecuencia, la intensidad de corriente y la duración, son idénticos a los del grupo activo.
Sin embargo, se activa el modo de estimulación simulada en el dispositivo, lo que resulta en que no se suministra corriente real durante la estimulación.
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The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group.
However, the sham stimulation mode is activated on the device, resulting in consist of a 5-s current ramp-up, but 0 s of continuous stimulation during the stimulation.
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Experimental: Temporal Interference Stimulation Group
The first pair of electrodes continuously delivers a current at a frequency of f1 = 2 kHz, while the second pair delivers a current at f2 = 2.130 kHz.
Based on the principle of temporal interference, an alternating electric field at a frequency of f1 - f2 = 130 Hz is generated in the target region.
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Each session will comprise 240 trials, during which stimulation may be triggered up to 10 times according to the participant's cue-reactivity state.
Each stimulation will consist of a 5-s current ramp-up, 30 s of continuous stimulation, and a 5-s current ramp-down.
The intervention will be administered once daily for five consecutive days.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change of Craving
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Visual Analog Scale, range0-100 point.
the higher the score, the more one wants drugs.
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baseline, 1 day after treatment, 1 month after treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Obsessive-Compulsive Drug Use Scale score
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Drug-related obsessive thoughts and compulsive behaviours will be assessed using the Obsessive-Compulsive Drug Use Scale (OCDUS).
The scale consists of 14 items rated from 0 to 4, producing a total score ranging from 0 to 56.
Higher scores indicate more severe drug-related obsessive thoughts, craving, and impaired control over drug use.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Impulsive System score
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Impulsive tendencies will be assessed using the Impulsive System subscale of the Dual-Mode of Self-Control Scale (DMSC-S).
The subscale contains 12 items rated from 1 to 5, producing a total score ranging from 12 to 60. Higher scores indicate stronger impulsive-system tendencies, including greater impulsivity, distractibility, and preference for immediate gratification.
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baseline, 1 day after treatment, 1 month after treatment
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Dual-Mode of Self-Control Scale-Control System score
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Self-control will be assessed using the Control System subscale of the Dual-Mode of Self-Control Scale (DMSC-S).
The subscale contains 9 items rated from 1 to 5, producing a total score ranging from 9 to 45. Higher scores indicate stronger self-control, including better problem-solving and future-oriented planning.
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baseline, 1 day after treatment, 1 month after treatment
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Stop Single Task
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Response inhibition will be assessed using the Stop-Signal Task.
The primary behavioural parameter will be the reaction time and accuracy, measured in milliseconds.
A longer stop-signal reaction time indicates poorer inhibitory control, whereas a shorter stop-signal reaction time indicates better inhibitory control.
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baseline, 1 day after treatment, 1 month after treatment
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EEG ERP amplitude during the Stop-Signal Task
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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The mean amplitude of the stop-related event-related potential and functional connection will be measured in microvolts over frontocentral electrodes within the prespecified post-stimulus time window.
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baseline, 1 day after treatment, 1 month after treatment
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Decision-making Preferences and Delay of Gratification
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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delay discounting task,Delay of gratification will be assessed using a computerised delay-discounting task in which participants choose between smaller immediate rewards and larger delayed rewards.
The discounting-rate parameter, k, will be estimated from participants' choices.
A higher k value indicates steeper delay discounting, a stronger preference for immediate rewards, and a lower ability to delay gratification.
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baseline, 1 day after treatment, 1 month after treatment
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Changes in Reward Learning
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Reward learning will be assessed using a computerised reinforcement-learning task.
A computational reinforcement-learning model will be fitted to participants' trial-by-trial choices.
The learning-rate parameter, alpha, ranges from 0 to 1 and represents the extent to which recent feedback is used to update expected values.
Higher values indicate greater updating in response to recent feedback.
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baseline, 1 day after treatment, 1 month after treatment
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sensitivity to reward and punishment
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to punishment will be assessed using the Sensitivity to Punishment subscale of the Sensitivity to Punishment and Sensitivity to Reward Questionnaire (SPSRQ).
The subscale contains 24 dichotomous items scored 0 or 1, producing a score ranging from 0 to 24.
Higher scores indicate greater sensitivity to punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Behavioral Inhibition/Activation System Scale
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Sensitivity to anticipated punishment will be assessed using the 7-item Behavioural Inhibition System subscale of the Behavioural Inhibition System/Behavioural Activation System Scales.
Each item is rated from 1 to 4, producing a score ranging from 7 to 28.
Higher scores indicate greater behavioural inhibition and sensitivity to anticipated punishment.
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baseline, 1 day after treatment, 1 month after treatment
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Beck Depression Inventory-II score
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Depressive symptom severity will be assessed using the Beck Depression Inventory-II (BDI-II).
The inventory consists of 21 items rated from 0 to 3, producing a total score ranging from 0 to 63.
Higher scores indicate more severe depressive symptoms.
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baseline, 1 day after treatment, 1 month after treatment
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Drug-cue Flanker task
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Attentional interference from methamphetamine-related cues will be assessed using a computerised drug-cue Flanker task.
The drug-cue attentional interference effect will be calculated as the difference in mean reaction time between trials containing methamphetamine-related cues and trials containing neutral cues, measured in milliseconds.
A larger positive value indicates greater attentional interference from methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG theta power
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Theta-band power will be quantified within the prespecified frequency range, electrode region, and post-stimulus time window.
The cue-related theta effect will be calculated as the difference between methamphetamine-related and neutral cue conditions.
A larger value indicates a stronger theta-band response to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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EEG P3 amplitude
Periodo de tiempo: baseline, 1 day after treatment, 1 month after treatment
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Task-related electroencephalography will be recorded during the drug-cue Flanker task and the reward learning task.
The mean amplitude of the P3 event-related potential will be measured in microvolts within the prespecified electrode region and post-stimulus time window.
A larger positive difference indicates greater neural reactivity to methamphetamine-related cues.
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baseline, 1 day after treatment, 1 month after treatment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Min Zhao, PhD, Shanghai Mental Health Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de septiembre de 2026
Finalización primaria (Estimado)
30 de octubre de 2026
Finalización del estudio (Estimado)
1 de noviembre de 2026
Fechas de registro del estudio
Enviado por primera vez
30 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- MZhao-029
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .