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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Mental Health Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Closed-loop cTBS stimulation based on addiction-induced statesExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
through study completion, an average of 1 month

Secondary outcomes

1

Changes of electroencephalogram power spectrum

Resting-state EEG can be used to extract power spectra and electrode functional connectivity; on-task EEG can be used to isolate time-frequency features during non-stimulated trials to extract alpha, beta, theta, and gamma band energy of the parietal and occipital electrodes. Both can be used to assess changes in neural activity before, during, and after their restimulation.

Time frame
through study completion, an average of 1 month
2

Probabilistic inversion learning task

The matching of symbols and colours was reversed without informing the subjects and their cognitive flexibility in the reversed condition was assessed

Time frame
through study completion, an average of 1 month
3

Anxiety

The reduction rate in the Beck Anxiety Inventory (BAI) scores was calculated before and after intervention to assess the rate of decrease in anxiety levels among MA dependents.

Time frame
through study completion, an average of 1 month
4

Depression

The reduction rate in the Beck Depression Inventory (BDI) scores was calculated before and after the intervention to evaluate the rate of reduction in their levels of depression.

Time frame
through study completion, an average of 1 month

Other outcomes

Sponsors and contacts

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