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Substance Use Disorder, Brain and Behavioral Regulation

U

University of Puerto Rico (UPR)

Status

Withdrawn

Conditions

Substance Use Disorders

Treatments

Device: QEEG-Guided sLoreta Neurofeedback Training

Study type

Interventional

Funder types

Other

Identifiers

NCT05910749
PuertoRico

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

21 to 51 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

QEEG-guided sLoreta Neurofeedback
Experimental group
Description:
Brainmaster Discovery 24 EEG amplifier and BrainAvatar software will be used to conduct the neurofeedback sessions
Treatment:
Device: QEEG-Guided sLoreta Neurofeedback Training

Trial contacts and locations

1

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Central trial contact

Ismael Castillo Reyes, PHD; Ismael Castillo

Data sourced from clinicaltrials.gov

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