Substance Use Disorder, Brain and Behavioral Regulation

Not Applicable

Recruiting

• Conditions: Substance Use Disorders
• Interventions: Device: QEEG-Guided sLoreta Neurofeedback Training

• Registration Number: NCT05910749
• Lead Sponsor: University of Puerto Rico

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-27
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-20
• Study Start: 2023-11-01
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
QEEG-guided sLoreta Neurofeedback	QEEG-Guided sLoreta Neurofeedback Training	Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions

Primary Outcome Measures

Name	Time	Method
sLORETA Brodmann Areas Voxels Z-Scores	2 months	An increase of the percent of sLORETA Brodmann Areas Voxels Z-Scores inside the target window of -/+2 standard deviations after a series of ZQLN sessions is expected.
Event-Related Potentials P300 amplitudes Drug-cue Go	2 months	Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.
Event-Related Potentials P300 latencies	2 months	Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.

Secondary Outcome Measures

Name	Time	Method
Attentional Executive Functioning NIH Toolbox Task	2 months	Flanker Inhibitory Control and Attention Task. The allocation of one's limited capacities to deal with abundance of environmental stimulation (duration 3 minutes)
Working Memory NIH Toolbox Task	2 months	List Sorting Working Memory Task. The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information. (7 minutes duration)
Executive Function NIH Toolbox Task	2 months	Dimensional Change Card Sort Task. The capacity to plan, organize, and monitor the executive of behaviors that are strategically directed in a goal-oriented manner. (4 minutes duration)
Processing Speed NIH Toolbox Task	2 months	Pattern Comparison Processing Speed Test. Assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. (3 minute duration)
Drug-cue NoGo Task Commission Errors	2 months	Average frequency of commission errors (responding to the NoGo stimulus). In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.
Drug-cue Go Task Reaction Times	2 months	Average Reaction times (measured in milliseconds) to the Go stimulus. In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.
Episodic Memory NIH Toolbox Task	2 months	Picture Sequence Memory Task. Cognitive processes involved in the acquisition, storage and retrieval of new information. (7 minutes duration)
Drug-cue Go Task Omission Errors	2 months	Average frequency of omission errors (not responding to the Go stimulus). In the first block of the task the Go stimulus will be a neutral category (animal or household) and in the second block the Go stimulus will be the drug-related picture.

Trial Locations

Locations (1)

Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones; 🇵🇷 San Juan, Puerto Rico