tTIS Targeted of the Striatum as an Intervention for MUD Patients

August 31, 2026 updated by: Shanghai Mental Health Center

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
53

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai, Shanghai, China, 200000
      • Shanghai, Shanghai, Shanghai, China, 200000, China, 200030
        • Shanghai Mental Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 6 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: Temporal Interference Stimulation
The stimulation duration are 30 minutes per session, administered twice daily for 5 consecutive days.
Sham Comparator: Control Group
The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. Sham stimulation used the same montage and ramp procedures but delivered stimulation for only 1 minute per session before the stimulator was turned off.
Device: Shame
The stimulation parameters-including frequency, current intensity, and duration-are identical to those in the active group. Sham stimulation used the same montage and ramp procedures but delivered stimulation for only 1 minute per session before the stimulator was turned off.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Drug Use
Time Frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
OCDUSE scale
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity
Time Frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Stop Single Task
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
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
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
EEG
Time Frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
source power of each frequency band
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
EEG
Time Frame: baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
change of functional connection of brain area
baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Mental Health Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Min Zhao, PhD, Shanghai Mental Health Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MZhao-020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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