Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders

• Sponsor: Cardiff University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02406456
• Collaborator: European Commission (Other)
• Enrollment: 15
• Location: 1
• Arm: 1
• Duration (Months): 5
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Alcohol Abuse	Other: Neurofeedback	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Real-time fMRI Neurofeedback as a Treatment Tool for Alcohol Dependence - Protocol Optimisation Phase
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurofeedback	Other: Neurofeedback

Outcome Measures

Primary Outcome Measures

1. Neurofeedback success (brain activation difference during neurofeedback and baseline blocks) [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.

Secondary Outcome Measures

1. Drinking Urges Questionnaire as a measure of alcohol craving [1 day]

   Measure of alcohol craving

2. Alcohol Stroop task as a measure of cognitive bias [1 day]

   Measure of cognitive bias

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Medicine, Cardiff University	Cardiff	Wales	United Kingdom	CF14 4XN

Sponsors and Collaborators

• Cardiff University
• European Commission

Investigators

• Principal Investigator: David Linden, MD, Cardiff University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Linden, Professor of Translational Neuroscience, Cardiff University
• ClinicalTrials.gov Identifier: NCT02406456
• Other Study ID Numbers: BRAINTRAINPILOT
• First Posted: Apr 2, 2015
• Last Update Posted: Nov 11, 2015
• Last Verified: Nov 1, 2015

• Additional relevant MeSH terms: Alcoholism

Study Results

No Results Posted as of Nov 11, 2015