Optimisation of Functional MRI-based Neurofeedback for Alcohol Use Disorders

Alcohol Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406456
• Other study ID #: BRAINTRAINPILOT
• Status: Completed
• Phase: N/A
• First received: March 26, 2015
• Last updated: November 10, 2015
• Start date: March 2015
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Cardiff University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Abuse

Intervention

Other:
• Neurofeedback

Locations

Country	Name	City	State
United Kingdom	School of Medicine, Cardiff University	Cardiff	Wales

Sponsors (2)

Lead Sponsor	Collaborator
Cardiff University	European Commission

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurofeedback success (brain activation difference during neurofeedback and baseline blocks)	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	No
Secondary	Drinking Urges Questionnaire as a measure of alcohol craving	Measure of alcohol craving	1 day	No
Secondary	Alcohol Stroop task as a measure of cognitive bias	Measure of cognitive bias	1 day	No