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

31 sierpnia 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Interwencyjne

Zapisy (Szacowany)

50

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Potroić

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Pozorny komparator: Grupa kontrolna
Parametry stymulacji – w tym częstotliwość, natężenie prądu i czas trwania – są identyczne jak w grupie aktywnej. Jednakże na urządzeniu aktywowany jest tryb stymulacji pozornej, co skutkuje brakiem dostarczania rzeczywistego prądu podczas stymulacji.
Urządzenie: 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.
Eksperymentalny: 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.
Urządzenie: 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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change of Craving
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Obsessive-Compulsive Drug Use Scale score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Shanghai Mental Health Center

Śledczy

  • Krzesło do nauki: Min Zhao, PhD, Shanghai Mental Health Center

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

30 października 2026

Ukończenie studiów (Szacowany)

1 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

30 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 sierpnia 2026

Pierwszy wysłany (Rzeczywisty)

3 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

3 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

31 sierpnia 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Inne numery identyfikacyjne badania

  • MZhao-029

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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