tTIS Targeted of the Striatum as an Intervention for MUD Patients

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: Not yet recruiting
• Conditions: Amphetamine Use Disorders
• Intervention / Treatment: Device: Temporal Interference Stimulation; Device: Shame

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: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Min Zhao, PhD; Phone Number: 64387250; Email: drminzhao@gmail.com
• Study Contact Backup: Name: Tianzhen Chen, PhD; Phone Number: 64387250; Email: vomchan@hotmail.com

Study Locations

• China
  • Shanghai, Shanghai, China, 200000
    • Shanghai, Shanghai, Shanghai, China, 200000, China, 200030
      • Shanghai Mental Health Center
      • Contact: Min Zhao, Phd; Phone Number: 64387250 18017311005; Email: drminzhao@smhc.org.cn

Participation Criteria

Eligibility Criteria

• 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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Temporal Interference Stimulation Group; The first pair of electrodes continuously delivers a current at a frequency of f1 = 1 kHz, while the second pair delivers a current at f2 = 1.130 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. However, the sham stimulation mode is activated on the device, resulting in no actual current being delivered during the stimulation.	Device: 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 no actual current being delivered during the stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Craving	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

Outcome Measure	Measure Description	Time Frame
Drug Use	OCDUSE scale	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity	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	the Impulsive-Control Dual Systems Scale	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
impulsivity	Stop Single Task	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
Changes in Reward Learning	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	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	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	the BDI Depression Inventory	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
emotional state	the BAI Anxiety Inventory	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
sleep quality	the PSQI Sleep Quality Index	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment
EEG	source power of each frequency band	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment
EEG	change of functional connection of brain area	baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Study Chair: Min Zhao, PhD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 26, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: July 9, 2025
• First Submitted That Met QC Criteria: March 15, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Amphetamine-type stimulants; temporal interference stimulation
• Other Study ID 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