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Substance Use Disorder, Brain and Behavioral Regulation

Primary Purpose

Substance Use Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Puerto Rico
Study Type
Interventional
Intervention
QEEG-Guided sLoreta Neurofeedback Training
Sponsored by
University of Puerto Rico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Use Disorders

Eligibility Criteria

21 Years - 51 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

QEEG-guided sLoreta Neurofeedback

Arm Description

Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions

Outcomes

Primary Outcome Measures

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.
Event-Related Potentials P300 latencies
Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.
Event-Related Potentials P300 amplitudes Drug-cue Go
Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.

Secondary Outcome Measures

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)
Episodic Memory NIH Toolbox Task
Picture Sequence Memory Task. Cognitive processes involved in the acquisition, storage and retrieval of new information. (7 minutes duration)
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)
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)
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)
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.
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.
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.

Full Information

First Posted
March 27, 2023
Last Updated
September 13, 2023
Sponsor
University of Puerto Rico
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1. Study Identification

Unique Protocol Identification Number
NCT05910749
Brief Title
Substance Use Disorder, Brain and Behavioral Regulation
Official Title
Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Puerto Rico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre-experimental repeated measured design
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
QEEG-guided sLoreta Neurofeedback
Arm Type
Experimental
Arm Description
Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions
Intervention Type
Device
Intervention Name(s)
QEEG-Guided sLoreta Neurofeedback Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
sLORETA Brodmann Areas Voxels Z-Scores
Description
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.
Time Frame
2 months
Title
Event-Related Potentials P300 latencies
Description
Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.
Time Frame
2 months
Title
Event-Related Potentials P300 amplitudes Drug-cue Go
Description
Brain response P300 component average amplitudes (measured in microvolts) during Drug-cue GoNoGo. task.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Attentional Executive Functioning NIH Toolbox Task
Description
Flanker Inhibitory Control and Attention Task. The allocation of one's limited capacities to deal with abundance of environmental stimulation (duration 3 minutes)
Time Frame
2 months
Title
Episodic Memory NIH Toolbox Task
Description
Picture Sequence Memory Task. Cognitive processes involved in the acquisition, storage and retrieval of new information. (7 minutes duration)
Time Frame
2 months
Title
Working Memory NIH Toolbox Task
Description
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)
Time Frame
2 months
Title
Executive Function NIH Toolbox Task
Description
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)
Time Frame
2 months
Title
Processing Speed NIH Toolbox Task
Description
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)
Time Frame
2 months
Title
Drug-cue Go Task Reaction Times
Description
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.
Time Frame
2 months
Title
Drug-cue Go Task Omission Errors
Description
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.
Time Frame
2 months
Title
Drug-cue NoGo Task Commission Errors
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
51 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ismael Castillo Reyes, PhD
Organizational Affiliation
University of Puerto Rico
Official's Role
Principal Investigator
Facility Information:
Facility Name
Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones
City
San Juan
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wanda Melendez
Phone
7875397272
Email
wmelendez@assmca.pr.gov

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and findings will be published in peer-review health sciences journals and presented at national and international scientific conferences, especially those related to Neurotherapy, cognitive neuroscience, and biological psychiatry. Findings and insights gained from this study will be shared with government agencies, and medical institutions that provide services for neuro and psychiatric patients, both in Puerto Rico and in the U.S. General Data, without personal identifiers, will be made available to other researchers in Puerto Rico and other institutions outside the country for secondary analyses in their areas of expertise, or confirmation of the adequacy of our findings and conclusions. The research resources developed during the proposed project will be readily available for research purposes to qualified individuals within the scientific community to advance further research in this field. Findings will also be shared via newspapers, news releases, and press conferences.
IPD Sharing Time Frame
Data will be available for one year after the study completion.
IPD Sharing Access Criteria
Email to ismael.castillo@upr.edu

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Substance Use Disorder, Brain and Behavioral Regulation

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