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Clinical Trials/NCT02406456
NCT02406456CompletedNot Applicable

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

Cardiff University1 site in 1 country15 target enrollmentStarted: March 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
15
Locations
1
Primary Endpoint
Neurofeedback success (brain activation difference during neurofeedback and baseline blocks)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Neurofeedback

Experimental

Intervention: Neurofeedback (Other)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Alcohol Stroop task as a measure of cognitive bias(1 day)
  • Drinking Urges Questionnaire as a measure of alcohol craving(1 day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Linden

Professor of Translational Neuroscience

Cardiff University

Study Sites (1)

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