A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

Part of paid clinical trials in Auburn, Alabama.

Sponsor
Auburn University
Study ID
NCT05621538
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Oct 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Neurofeedback-active + TMS-active
    4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)
  • Active Comparator: Neurofeedback-active + TMS-sham
    4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of own brain activity from multiple ROIs measured using fMRI)
  • Active Comparator: Neurofeedback-sham + TMS-active
    4 sessions of: TMS (protocol: 10 Hz pulses delivered at 110% of MT in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)
  • Sham Comparator: Neurofeedback-sham + TMS-sham
    4 sessions of: TMS (protocol: 10 Hz pulses delivered using the Sham TMS coil in 60 x 5 sec trains with 25 sec ITI) Neurofeedback (protocol: presentation of other's brain activity from multiple ROIs measured using fMRI)
  • No Intervention: Check-In Only
    4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)

Primary Outcome Measure

Change in Alcohol Use over Time [ 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Auburn UniversityAuburnAlabama36849
SCAMPI Lab
[email protected]
334-521-2807
Samantha J Fede, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Auburn, AL

By condition
Substance use disorder
By specialty
Behavioral healthAddiction medicine
By research site
Auburn University· Auburn, AL

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