Individualized Neuromodulation for the Core Clinical Features of Drug Addiction

Shanghai Mental Health Center9 enrolled

Overview

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

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 transcranial alternating current stimulation (tACS) technique, predicated upon biomarkers of addiction states, to administer specific frequency stimulations to targeted brain regions, aiming to achieve therapeutic objectives in addiction treatment.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Amphetamine Use Disorders

Interventions

Closed-loop tACS stimulation based on addiction-induced statesDEVICE

We will conduct a crossover study of closed-loop tACS interventions among participants with methamphetamine use disorder. Participants will receive three single-session EEG-triggered closed-loop tACS interventions at frequencies previously reported to improve cognitive control, administered in a counterbalanced within-subject order. After the optimal frequency is identified based on the predefined neurobehavioral outcomes, participants will receive two additional conditions at the same frequency: random-time stimulation and open-loop continuous stimulation. All five stimulation sessions will be separated by a 5-day interval.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals aged between 18 and 55 years, irrespective of gender, having completed a minimum of 9 years of education or capable of effectively cooperating in questionnaire and behavioral task evaluations. * Meet the diagnostic criteria set forth by the DSM-5 concerning the severity of 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 tACS, such as a history of epileptic seizures or the presence of metallic implants in proximity to the head.

Locations (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Stop-signal reaction time (SSRT) from the stop-signal task

The stop-signal task can indicate executive control capabilities by measuring Stop-signal reaction time. A shorter SSRT indicates better inhibitory functions.

Time frame: Through study completion, an average of 1 month

Secondary Outcomes

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

Data from ClinicalTrials.gov

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