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Active, Not Recruiting

NCT Number: NCT07479771

tTIS Targeted of the Striatum as an Intervention for MUD Patients

Targeted temporal interference stimulation (tTIS) of the caudate nucleus can modulate the abnormal electrophysiological activity in individuals with methamphetamine use disorder (MUD), thereby improving their impaired reward-learning behaviors and reducing drug craving.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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, Shanghai, China, 200000, 200030, China

About this study

This project will recruit MUD patients. A 5-day intervention protocol of real or sham tTIS targeting the caudate nucleus will be employed. Before and after intervention, drug craving anddrug use and other questionnaire as well as stop-signal tasks, and reward-learning tasks will be used to evaluate its therapeutic efficacy on clinical craving and the underlying neural mechanisms.

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

The stimulation duration are 30 minutes per session, administered twice daily for 5 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 no actual current being delivered during the stimulation.

Primary outcomes

  1. Change of Craving

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

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

Secondary outcomes

  1. Drug Use

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    OCDUSE scale

  2. impulsivity

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    This study employed the BIS-11 Impulsiveness Scale

  3. impulsivity

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    the Impulsive-Control Dual Systems Scale

  4. impulsivity

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    Stop Single Task

  5. Changes in Reward Learning

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    Reward LearningTask

  6. Decision-making Preferences and Delay of Gratification

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    delay discounting task

  7. sensitivity to reward and punishment

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    the Sensitivity to Punishment and Sensitivity to Reward Questionnaire, the Cognitive Flexibility Scale, the Behavioral Inhibition/Activation System Scale

  8. emotional states

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    the BDI Depression Inventory

  9. emotional state

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    the BAI Anxiety Inventory

  10. sleep quality

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

    the PSQI Sleep Quality Index

  11. EEG

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment

    source power of each frequency band

  12. EEG

    Time frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment

    change of functional connection of brain area

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

Transcranial Temporal Interference Stimulation Targeted of the Striatum as an Intervention for Methamphetamine Use Disorder Patients

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Jun 30, 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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