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Closed-loop tTIS Targeted of the Nac as an Intervention for MUD Patients

31. srpna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Čína, 200030
        • Shanghai Mental Health Center
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Trojnásobný

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Falešný srovnávač: Kontrolní skupina
Parametry stimulace – včetně frekvence, intenzity proudu a délky trvání – jsou shodné s parametry aktivní skupiny. Avšak na zařízení je aktivován režim falešné (sham) stimulace, což znamená, že během stimulace není dodáván žádný skutečný proud.
Přístroj: Shame
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.
Experimentální: 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.
Přístroj: Temporal Interference Stimulation
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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change of Craving
Časové okno: baseline, 1 day after treatment, 1 month after treatment
Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.
baseline, 1 day after treatment, 1 month after treatment

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Obsessive-Compulsive Drug Use Scale score
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Dual-Mode of Self-Control Scale-Impulsive System score
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Dual-Mode of Self-Control Scale-Control System score
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Stop Single Task
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
EEG ERP amplitude during the Stop-Signal Task
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Decision-making Preferences and Delay of Gratification
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Changes in Reward Learning
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
sensitivity to reward and punishment
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Behavioral Inhibition/Activation System Scale
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Beck Depression Inventory-II score
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
Drug-cue Flanker task
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
EEG theta power
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment
EEG P3 amplitude
Časové okno: baseline, 1 day after treatment, 1 month after treatment
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.
baseline, 1 day after treatment, 1 month after treatment

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Shanghai Mental Health Center

Vyšetřovatelé

  • Studijní židle: Min Zhao, PhD, Shanghai Mental Health Center

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. září 2026

Primární dokončení (Odhadovaný)

30. října 2026

Dokončení studie (Odhadovaný)

1. listopadu 2026

Termíny zápisu do studia

První předloženo

30. července 2026

První předloženo, které splnilo kritéria kontroly kvality

31. srpna 2026

První zveřejněno (Aktuální)

3. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

3. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

31. srpna 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

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  • MZhao-029

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