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

31. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Kina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200030
        • Shanghai Mental Health Center
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Sham-komparator: Kontrollgruppe
Stimuleringsparameterne – inkludert frekvens, strømstyrke og varighet – er identiske med de i aktivgruppe. Imidlertid er sham-stimuleringsmodusen aktivert på enheten, noe som resulterer i at ingen faktisk strøm leveres under stimuleringen.
Enhet: 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.
Eksperimentell: 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.
Enhet: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change of Craving
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Obsessive-Compulsive Drug Use Scale score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Shanghai Mental Health Center

Etterforskere

  • Studiestol: Min Zhao, PhD, Shanghai Mental Health Center

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

30. oktober 2026

Studiet fullført (Antatt)

1. november 2026

Datoer for studieregistrering

Først innsendt

30. juli 2026

Først innsendt som oppfylte QC-kriteriene

31. august 2026

Først lagt ut (Faktiske)

3. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • MZhao-029

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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