Closed-loop cTBS for the Core Clinical Features of Methamphetamine Use Disorder

NCT06457243 | Recruiting

• 1 other identifier: MZhao-019
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Using specific EEG biomarkers in methamphetamine-dependent individuals, this study systematically probes closed-loop continuous Theta-burst Stimulation (cTBS) based on brain states, assessing dosage, neurologic and behavioral effects, while comparing its efficacy with traditional open-loop cTBS methods.

Conditions

Amphetamine Use Disorders

Keywords

individualized therapy; closed-loop; Amphetamine-type stimulants; cTBS

Outcome Measures

Primary Outcomes (1)

• Change of Craving assessed by Visual Analog Scale (VAS)

  The intensity of psychological craving in MA dependents was assessed using the Visual Analogue Scale (VAS), where individuals rated their cravings on a scale from 0 to 10, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation. individuals rated their cravings on a scale from 0 to 10, with higher scores indicating greater levels of craving. The VAS scores were utilized based on two conditions: during a resting state and when subjected to cue induction involving images associated with methamphetamine, serving as the criteria for evaluation.

  through study completion, an average of 1 month

Secondary Outcomes (5)

• Changes of electroencephalogram power spectrum

  through study completion, an average of 1 month

• Probabilistic inversion learning task

  through study completion, an average of 1 month

• Anxiety

  through study completion, an average of 1 month

• Depression

  through study completion, an average of 1 month

• sleep quality

  through study completion, an average of 1 month

Study Arms (1)

Closed-loop cTBS stimulation based on addiction-induced states

EXPERIMENTAL

In the initial phase of this study, participants will be subjected to individual closed-loop cTBS interventions at varying frequencies for one-week intervals. Concurrently, they will be exposed to MA-related cue paradigms to induce brain addiction states, while scalp EEG signals are collected. Stimulation will be initiated only upon identifying specific neural signals associated with MA cues, aiming to ascertain the optimal frequency for single-session closed-loop cTBS stimulation that could elicit individual neurological responses. Subsequently, we will embark on a longitudinal closed-loop cTBS intervention control study for MA dependents at one-week intervals, which involves addiction-induced closed-loop cTBS stimulation, random time-point stimulation, and traditional continuous stimulation, to rectify potential sequence effects and delineate the disparities in neurological and behavioral impacts between discrete and continuous stimulations based on brain states.

Device: Closed-loop cTBS stimulation based on addiction induced states

Interventions

Closed-loop cTBS stimulation based on addiction induced states DEVICE

We conducted a longitudinal controlled study of closed-loop cTBS interventions among MA dependents.This involved implementing interventions based on addiction-induced states through closed loop cTBS stimulation, randomized time-point stimulation, and traditional continuous stimulation.

Closed-loop cTBS stimulation based on addiction-induced states

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Individuals aged between 18 and 60 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Min Zhao, PhD

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Study Officials

• Min Zhao, PhD

  Shanghai Mental Health Center

  STUDY CHAIR

Central Study Contacts

Min Zhao, PhD

CONTACT

64387250; drminzhao@gmail.com

Hang Su, PhD

CONTACT

64387250; drminzhao@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 13, 2024
• Study Start: August 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: August 1, 2025
• Last Updated: June 13, 2024

Record last verified: 2024-06

Locations

CN (1)