NCT05910749

Substance Use Disorder, Brain and Behavioral Regulation

Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Puerto Rico · Academic / Other
• Sex: All
• Age: 21 Years – 51 Years
• Healthy volunteers: Not accepted

Summary

The proposed project seeks to explore the effects of a neuroregulation paradigm named Z-Score Quantitative Electroencephalogram (QEEG) guided sLORETA neurofeedback (ZQLN) on optimizing brain electrophysiological activity and behavioral performance in a substance use disorder (SUD) population whose primary drug of use is cocaine.

Detailed description

Aim 1. Measure the effects of ZQLN training on brain electrophysiological activation changes in SUD patients. QEEG and Event-Related Potentials procedures, recorded with a 19-channel digital EEG, will be conducted before and after 12-15 sessions of ZQLN to examine changes on dysregulated brain sites by inspection of the brain maps deviating brain areas sLORETA Brodmann Areas Voxels Z-Scores inside and outside the target window of -/+2 standard deviations. Observation of P300 component latencies and amplitudes will be measured during a Drug-cue GoNoGo paradigm. Aim 2. Measure the effects of ZQLN training on behavioral performance changes in SUD patients. In the same participants of Aim 1, Pre and Post behavioral performance (before and after 12-15 sessions of ZQLN) includes the assessment of attention and executive function, episodic memory, working memory language, and processing speed as measured by the NIH Toolbox Cognitive Domains battery scales. Other behavioral variables include reaction times, omission, and commission errors in the Drug-cue GoNoGo task.

Conditions

• Substance Use Disorders

Interventions

Type	Name	Description
DEVICE	QEEG-Guided sLoreta Neurofeedback Training	The team will produce a neurofeedback (NFB) protocol based on QEEG sLORETA Brodmann Voxel evaluation of brain deviated/dysregulated areas. Subsequent 12 to15 sessions of individualized NFB protocol will be conducted using BrainAvatar software to normalize these regions. The NFB session will display the cortical surface and subsurface networks being trained in a live fashion. Patients will be seated on a comfortable chair in a dimly lit room and, wearing a 19-channel EEG-cap connected to an EEG amplifier, they will receive auditory and visual feedback when they meet Brodmann Voxels Z-Scores inside of +/-1.5 standard deviations (SD) on each electrode training site. Thresholds for the feedback will be first set a +/-2 SD and brought down to +/-1.5 SD throughout the sessions (subject performance dependent). Patients are encouraged to relax, hear the sounds, and watch a feedback game.

Timeline

• Start date: 2025-04-01
• Primary completion: 2026-03-31
• Completion: 2026-05-30
• First posted: 2023-06-20
• Last updated: 2025-10-10

Locations

1 site across 1 country: Puerto Rico