Clinical trial NCT06457243: Closed-loop cTBS for the Core Clinical Features of Methamphetamine Use Disorder
Official title: Closed-loop Neuromodulation Based on Individualised EEG Biomarkers of Methamphetamine Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amphetamine Use Disorders
Keywords: individualized therapy
closed-loop
Amphetamine-type stimulants
cTBS
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of Craving assessed by Visual Analog Scale (VAS)
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
measure: Changes of electroencephalogram power spectrum
timeFrame: through study completion, an average of 1 month
measure: Probabilistic inversion learning task
timeFrame: through study completion, an average of 1 month
measure: Anxiety
timeFrame: through study completion, an average of 1 month
measure: Depression
timeFrame: through study completion, an average of 1 month
measure: sleep quality
timeFrame: through study completion, an average of 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Min Zhao, PhD
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Min Zhao, PhD
role: STUDY_CHAIR
References: