Enhancing Brain Processing Via Neurofeedback in Addictive Disorders

Enhancing Brain Processing Via Neurofeedback in Addictive Disorders: A Pilot Study

The purpose of this study is to investigate the effects of neurofeedback training on measures of cognitive control and alcohol motivation among young adults who drink alcohol on a regular basis. Neurofeedback is a cognitive training technique that uses portable electroencephalography (EEG) technology to adjust brain activity through immediate sensory feedback. This study is using a type of EEG device called a MuseTM headset that monitors ongoing brain activity and synchronizes this information with a mindfulness training app on a mobile device. This study is a pilot study to examine the feasibility and effects of neurofeedback training in a sample of young adults. Future studies may use similar protocols with people who have substance use disorders or other mental health disorders.

Study Overview

• Status: Withdrawn
• Conditions: Alcohol Drinking
• Intervention / Treatment: Behavioral: EEG Neurofeedback

Detailed Description

The NFB studies conducted to date have utilized a wide range of methodologies and NFB training protocols. The outcome measures of NFB efficacy have also varied widely. As mentioned above, the studies also used expensive, non-portable equipment which may limit the application of NFB in treatment settings. This study seeks to address these limitations by using a commercially-available neurotechnology, the Muse™ headband by InteraXon (Toronto, ON, Canada) and using their standard NFB protocol built into the device application. This will maximize the standardization and portability of the NFB as essentially an "out of the box" intervention. The outcome measures will also capture multiple relevant domains, including clinical outcomes (e.g., drinking motivation) and neurocognitive performance (e.g., cognitive control / response inhibition).

The purpose of this study is to investigate the effects of NFB training on measures of cognitive control and alcohol motivation among young adults who engage in heavy episodic drinking (defined as exceeding 4+/5+ drinks per occasion for men/women).

The study will examine whether NFB reduces motivation/attention and craving for alcohol and attentional bias to alcohol-related cues. The primary outcome will be assessed by changes in the alcohol purchase task and approach/avoidance task, which participants will complete pre- and post-NFB training.

A secondary outcome is to determine whether NFB results in transfer of heightened fronto-cortical activity to improvements on general executive functioning following 8 sessions of NFB training. The secondary outcome will be assessed via changes in neurocognitive tasks assessing behavioural inhibition, risky decision making, and executive functioning, all of which will be administered pre- and post-NFB training.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N3K7
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Current undergraduate student, can be registered in the SONA research participant pool
• 18 years or older
• At least one self-reported heavy drinking episode in the last two weeks (e.g., consumption of 5/4+ alcoholic drinks in a single drinking episode for men/women).

Exclusion Criteria:

• History of stroke, seizures, or traumatic brain injury
• Any history of severe psychiatric disorders, including schizophrenia-spectrum, bipolar disorder, Post-traumatic stress disorder.
• Presence of skin conditions/headwear that cannot be removed on the forehead/scalp that could interfere with EEG signal (e.g., open cuts, eczema, heavy acne, or psoriasis)
• Greater than weekly use of cannabis or greater than monthly use of other illicit drugs (e.g. cocaine, methamphetamine, opioids, etc.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: EEG Neurofeedback; Within-subjects sessions of EEG neurofeedback	Behavioral: EEG Neurofeedback; Participants will undergo a baseline (pre) session, then be scheduled for 8 sessions of NFB, and finish with another session (post) after completion of all NFB sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alcohol motivation	Alcohol demand will be assessed via a hypothetical purchase task measuring self-reported consumption of alcohol across a range of prices. Primary dependent measure of this task is the amount of alcohol purchased and money spent.	14 days
Alcohol approach/avoidance bias	Approach-avoidance bias will be assessed via an implicit approach/avoidance task involving pushing or pulling images closer/farther away using a joystick. Primary dependent measure from this task is latency of response to alcohol vs. neutral images for the approach and avoidance conditions.	14 days
Alcohol craving	Subjective alcohol craving will be assessed via a visual analog scale (0-100, with 100 equal to maximum craving)	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavioural inhibition	Behavioural inhibition will be assessed via computerized task of inhibitory control (go/no-go task) requiring suppression of inappropriate behavioural responses to "no-go" cues. Primary dependent measure is the percentage of correct trials and percentage of inhibitory failures	14 days
Risky decision-making	Risky decision making will be assessed via a Balloon Analogue Risk Task involving pumping a hypothetical balloon with an unknown air capacity. Each pump results in greater points earned, but a popped balloon results in loss of all accumulated points. Primary dependent variable from this task is the total number of pumps and number of exploded balloons. Higher values for each variable reflect greater risk taking	14 days
Interference control	Interference control will be assessed via the Erikson Flanker Task involving making a behavioural response to a central stimulus (left/right arrow) that is flanked by arrows that either point in same direction (congruent) or opposite direction (incongruent). Primary dependent variable is the percentage of correct trials in congruent vs incongruent conditions.	14 days

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Michael Amlung, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): June 1, 2021
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: January 30, 2020
• First Submitted That Met QC Criteria: January 31, 2020
• First Posted (ACTUAL): February 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Cognition; Alcohol Use; Neurofeedback; Electroencephalography (EEG)
• Additional Relevant MeSH Terms: Drinking Behavior; Alcohol Drinking
• Other Study ID Numbers: HIREB#8178

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No