SUD, Brain and Behavioral Regulation

• Sponsor: University of Puerto Rico (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05910749
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 11
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorders	Device: QEEG-Guided sLoreta Neurofeedback Training	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Pre-experimental repeated measured designPre-experimental repeated measured design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: May 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm

Intervention/Treatment

Experimental: QEEG-guided sLoreta Neurofeedback Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions

Device: QEEG-Guided sLoreta Neurofeedback Training; The team will produce an 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. Event-Related Potentials P300 latencies [2 months]

   Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.

3. Event-Related Potentials P300 amplitudes Drug-cue Go [2 months]

   Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.

Secondary Outcome Measures

1. 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)

2. 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)

3. 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)

4. 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)

5. 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)

6. 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.

7. 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.

8. Drug-cue NoGo Task Comission 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 51 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones	San Juan		Puerto Rico	00935

Sponsors and Collaborators

• University of Puerto Rico

Investigators

• Principal Investigator: Ismael Castillo Reyes, PhD, University of Puerto Rico

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Puerto Rico
• ClinicalTrials.gov Identifier: NCT05910749
• Other Study ID Numbers: PuertoRico
• First Posted: Jun 20, 2023
• Last Update Posted: Jun 20, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

No Results Posted as of Jun 20, 2023