Health TrialsbyHealthPanel

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

ConditionAlcohol Use Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-65
SponsorAuburn University

About this trial

The goal of this clinical study is to test the effectiveness of a supplemental fMRI neurofeedback and/or TMS intervention in individuals seeking treatment for Alcohol Use Disorder.

After an initial visit, participants will come in once a week for four (4) weeks for an intervention session, which may or may not include TMS and MRI. Participants will be contacted for monthly follow-ups (remotely) for up to 12 months and will be asked to come in for two MRI follow-ups at 6 and 12 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 19-65

Receiving treatment for Alcohol Use Disorder

Disqualifiers

MRI Contraindications

Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)

Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr

Hearing loss, including tinnitus, that might be made worse by MRI or TMS

Trial design

Design model

Factorial

Treatments tested in this trial

  • Realtime fMRI Neurofeedback - Active

    Behavioral

    fMRI aided reinforcement of craving regulation

  • TMS - Active

    Device

    rTMS to right dorsolateral prefrontal cortex to reduce craving

  • Realtime fMRI Neurofeedback - Yoked Sham

    Behavioral

    Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation

  • TMS - Sham

    Device

    rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex

Treatment groups

90 Participants
are divided into 5 treatment groups
Group A: Neurofeedback-active + TMS-activeExperimental treatment 2 interventions
Group B: Neurofeedback-active + TMS-shamActive comparator 2 interventions
Group C: Neurofeedback-sham + TMS-activeActive comparator 2 interventions
Group D: Neurofeedback-sham + TMS-shamSham comparator 2 interventions
Group E: Check-In OnlyNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in Alcohol Use over Time

Alcohol Timeline Followback (alc-TLFB)

Time frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
2

Change in Alcohol Craving over Time

Alcohol Craving Questionnaire (ACQ)

Time frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
3

Change in Community Functioning over Time

Drinker Inventory of Consequences (DrInC)

Time frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
4

Change in Employment Status over Time

self-reported employment status

Time frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)

Secondary outcomes

1

Change in Brain Gray Matter Structure over Time

Measured via MRI; gray matter volume

Time frame
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
2

Change in Brain White Matter Structure over Time

Measured via MRI; white matter diffusion

Time frame
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
3

Change in Resting State Functional Connectivity over Time

Measured via fMRI

Time frame
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Auburn University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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