Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders

November 10, 2015 updated by: David Linden, Cardiff University

Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence - Protocol Optimisation Phase

Participants will undergo a single session of functional magnetic resonance imaging (fMRI)-based neurofeedback (approximately 1 hour). The investigators will assess their ability to regulate motivational networks of the brain during the exposure to alcohol cues and evaluate immediate effects on craving and cognitive bias for alcohol by administering a questionnaire and a Stroop task before and after the session.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Cardiff, Wales, United Kingdom, CF14 4XN
        • School of Medicine, Cardiff University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • History of alcohol use disorder or current alcohol consumption above 21 units (1 unit = 8g) of alcohol per week (male participants) or above 14 units of alcohol per week (female participants)

Exclusion Criteria:

  • MRI safety exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neurofeedback
Other: Neurofeedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurofeedback success (brain activation difference during neurofeedback and baseline blocks)
Time Frame: 1 day
This measure will be based on the analysis of participants' fMRI (functional magnetic resonance imaging) data, reflecting brain activation, during exposure to alcohol cues. Neurofeedback success will be defined as significant difference between activation levels (expressed as beta weights of a linear regression model) during the regulation periods compared to baseline. The significance will be determined by a t-test.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinking Urges Questionnaire as a measure of alcohol craving
Time Frame: 1 day
Measure of alcohol craving
1 day
Alcohol Stroop task as a measure of cognitive bias
Time Frame: 1 day
Measure of cognitive bias
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiff University

Collaborators

European Commission

Investigators

  • Principal Investigator: David Linden, MD, Cardiff University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 26, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

November 11, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRAINTRAINPILOT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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