NCT07479771

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
0mo left

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Mar 2026Jun 2026

First Submitted

Initial submission to the registry

July 9, 2025

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

March 26, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 18, 2026

Status Verified

January 1, 2026

Enrollment Period

2 months

First QC Date

July 9, 2025

Last Update Submit

March 15, 2026

Conditions

Amphetamine Use Disorders

Keywords

Amphetamine-type stimulantstemporal interference stimulation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Drug Use

    baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

  • impulsivity

    baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

  • impulsivity

    baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

  • impulsivity

    baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

  • Changes in Reward Learning

    baseline, 1 day after treatment, 7 day after treatment, 2 weeks after treatment, 13 weeks after treatment

  • +7 more secondary outcomes

Study Arms (2)

Temporal Interference Stimulation Group

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

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

Interventions

Temporal Interference StimulationDEVICE

The stimulation duration are 30 minutes per session, administered twice daily for 5 consecutive days.

Temporal Interference Stimulation Group
ShameDEVICE

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.

Control Group

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai, Shanghai, China, 200000, 200030, China

Location

Study Officials

  • Min Zhao, PhD

    Shanghai Mental Health Center

    STUDY CHAIR

Central Study Contacts

Min Zhao, PhD

CONTACT

64387250drminzhao@gmail.com

Tianzhen Chen, PhD

CONTACT

64387250vomchan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2025

First Posted

March 18, 2026

Study Start

March 26, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 18, 2026

Record last verified: 2026-01

Locations

CN(1)