Substance Use Disorder, Brain and Behavioral Regulation

Substance Use Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05910749
• Other study ID #: PuertoRico
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: University of Puerto Rico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: June 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 51 Years

Eligibility

Inclusion criteria

• Age limit: 21 to 51

• Cocaine as a primary drug of selection

• Be stable (such as not having reading or movement problems preventing them from using a computer keyboard or iPad).

• Have completed the first stage of treatment in the program (this first phase consists of the stabilization and detoxification period of the program participants)

Exclusion criteria

• History of brain injury.

• Previous experience with neurofeedback training.

• Being unavailable to complete assessments.

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Puerto Rico	Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones	San Juan

Sponsors (1)

Lead Sponsor	Collaborator
University of Puerto Rico

Country where clinical trial is conducted

Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sLORETA Brodmann Areas Voxels Z-Scores	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.	2 months
Primary	Event-Related Potentials P300 latencies	Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.	2 months
Primary	Event-Related Potentials P300 amplitudes Drug-cue Go	Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.	2 months
Secondary	Attentional Executive Functioning NIH Toolbox Task	Flanker Inhibitory Control and Attention Task. The allocation of one's limited capacities to deal with abundance of environmental stimulation (duration 3 minutes)	2 months
Secondary	Episodic Memory NIH Toolbox Task	Picture Sequence Memory Task. Cognitive processes involved in the acquisition, storage and retrieval of new information. (7 minutes duration)	2 months
Secondary	Working Memory NIH Toolbox Task	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)	2 months
Secondary	Executive Function NIH Toolbox Task	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)	2 months
Secondary	Processing Speed NIH Toolbox Task	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)	2 months
Secondary	Drug-cue Go Task Reaction Times	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.	2 months
Secondary	Drug-cue Go Task Omission Errors	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.	2 months
Secondary	Drug-cue NoGo Task Commission Errors	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.	2 months