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Enhancing Brain Processing Via Neurofeedback in Addictive Disorders

Primary Purpose

Alcohol Drinking

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
EEG Neurofeedback
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Alcohol Drinking focused on measuring Electroencephalography (EEG), Neurofeedback, Alcohol Use, Cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.)

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

EEG Neurofeedback

Arm Description

Within-subjects sessions of EEG neurofeedback

Outcomes

Primary Outcome Measures

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.
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.
Alcohol craving
Subjective alcohol craving will be assessed via a visual analog scale (0-100, with 100 equal to maximum craving)

Secondary Outcome Measures

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
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
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.

Full Information

First Posted
January 30, 2020
Last Updated
February 3, 2023
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT04252755
Brief Title
Enhancing Brain Processing Via Neurofeedback in Addictive Disorders
Official Title
Enhancing Brain Processing Via Neurofeedback in Addictive Disorders: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Study stopped prior to initiation due to COVID-19 complications
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Drinking
Keywords
Electroencephalography (EEG), Neurofeedback, Alcohol Use, Cognition

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study will utilize a pre-post within-subjects design. All participants will undergo a baseline (pre) session, then be scheduled for 8 sessions of neurofeedback, and finish with another session (post) after completion of all neurofeedback sessions.
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EEG Neurofeedback
Arm Type
Other
Arm Description
Within-subjects sessions of EEG neurofeedback
Intervention Type
Behavioral
Intervention Name(s)
EEG Neurofeedback
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol motivation
Description
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.
Time Frame
14 days
Title
Alcohol approach/avoidance bias
Description
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.
Time Frame
14 days
Title
Alcohol craving
Description
Subjective alcohol craving will be assessed via a visual analog scale (0-100, with 100 equal to maximum craving)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Behavioural inhibition
Description
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
Time Frame
14 days
Title
Risky decision-making
Description
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
Time Frame
14 days
Title
Interference control
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Amlung, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3K7
Country
Canada

12. IPD Sharing Statement

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Enhancing Brain Processing Via Neurofeedback in Addictive Disorders

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