NCT06457243

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

Closed-loop Neuromodulation Based on Individualised EEG Biomarkers of Methamphetamine Use Disorder

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Mental Health Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amphetamine Use Disorders

Interventions

Type	Name	Description
DEVICE	Closed-loop cTBS stimulation based on addiction induced states	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.

Timeline

• Start date: 2024-08-01
• Primary completion: 2024-12-01
• Completion: 2025-08-01
• First posted: 2024-06-13
• Last updated: 2024-06-13

Locations

1 site across 1 country: China