Study Stopped
The study was not carried out because it was not approved by NIH.
Substance Use Disorder, Brain and Behavioral Regulation
Brain and Behavioral Regulation Processes in a Population With Substance Use Disorder
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2023
CompletedFirst Posted
Study publicly available on registry
June 20, 2023
CompletedStudy Start
First participant enrolled
April 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
CompletedOctober 10, 2025
October 1, 2025
12 months
March 27, 2023
October 8, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Event-Related Potentials P300 latencies
Brain response P300 component average latencies (measured in milliseconds) Drug-cue GoNoGo task.
2 months
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 Outcomes (8)
Attentional Executive Functioning NIH Toolbox Task
2 months
Episodic Memory NIH Toolbox Task
2 months
Working Memory NIH Toolbox Task
2 months
Executive Function NIH Toolbox Task
2 months
Processing Speed NIH Toolbox Task
2 months
- +3 more secondary outcomes
Study Arms (1)
QEEG-guided sLoreta Neurofeedback
EXPERIMENTALBrainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- History of brain injury.
- Previous experience with neurofeedback training.
- Being unavailable to complete assessments.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Administración de Servicios de Salud Mental y Contra la Adicción. Centro Residencial de Mujeres y Varones
San Juan, PR, 00935, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ismael Castillo Reyes, PhD
University of Puerto Rico
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2023
First Posted
June 20, 2023
Study Start
April 1, 2025
Primary Completion
March 31, 2026
Study Completion
May 30, 2026
Last Updated
October 10, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available for one year after the study completion.
- Access Criteria
- Email to ismael.castillo@upr.edu
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.