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

Shanghai Mental Health Center

Status: Enrolling

Conditions: Amphetamine Use Disorders

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06457243

MZhao-019

Details and patient eligibility

About

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.

Full description

The current study delineates a robust correlation between prefrontal cortex EEG signals and the psychological craving associated with methamphetamine usage. Dependents exhibit heightened β oscillation energy in the MPFC region and diminished γ oscillation energy across the DLPFC-MPFC region. Previously, through the implementation of rTMS interventions on the left DLPFC, the investigators have successfully reduced the craving levels in users when exposed to relevant cues, coupled with observed decreases in β oscillation energy and increases in γ oscillation energy in the MPFC region. This indicates that both β and γ oscillation energies are instrumental in representing the involvement of MPFC and DLPFC during craving episodes, and neuromodulatory technologies can modulate these energy levels, consequently reducing cravings. Furthermore, the investigators identified a significant augmentation in the theta energy in the occipital lobe when MA dependents are confronted with drug-related cue imagery, signifying a potential crucial neural marker for addiction-induced brain activity. Therefore, the investigators intend to employ the non-invasive continuous Theta-burst Stimulation (cTBS) , predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Closed-loop cTBS stimulation based on addiction-induced states

Experimental group

Description:

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.

Treatment:

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