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NCT Number: NCT07802223

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

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location contact

Min Zhao, Phd

CONTACT

[email protected]

18017311005 ext. 64387250

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

temporal interference stimulation

Device

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.

Shame

Device

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.

Primary outcomes

  1. Change of Craving

    Time frame: baseline, 1 day after treatment, 1 month after treatment

    Visual Analog Scale, range0-100 point. the higher the score, the more one wants drugs.

Secondary outcomes

  1. Obsessive-Compulsive Drug Use Scale score

    Time frame: 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.

  2. Dual-Mode of Self-Control Scale-Impulsive System score

    Time frame: 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.

  3. Dual-Mode of Self-Control Scale-Control System score

    Time frame: 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.

  4. Stop Single Task

    Time frame: 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.

  5. EEG ERP amplitude during the Stop-Signal Task

    Time frame: 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.

  6. Decision-making Preferences and Delay of Gratification

    Time frame: 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.

  7. Changes in Reward Learning

    Time frame: 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.

  8. sensitivity to reward and punishment

    Time frame: 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.

  9. Behavioral Inhibition/Activation System Scale

    Time frame: 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.

  10. Beck Depression Inventory-II score

    Time frame: 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.

  11. Drug-cue Flanker task

    Time frame: 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.

  12. EEG theta power

    Time frame: 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.

  13. EEG P3 amplitude

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Min Zhao, PhD

CONTACT

[email protected]

64387250

Tianzhen Chen, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Closed-loop Transcranial Temporal Interference Stimulation Targeted of the Nucleus Accumbens as an Intervention for Methamphetamine Use Disorder Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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