RecruitingNot ApplicableNCT05621538

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder


Sponsor

Auburn University

Enrollment

90 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 19 YearsMax Age: 65 Years

Inclusion Criteria2

  • Age 19-65
  • Receiving treatment for Alcohol Use Disorder

Exclusion Criteria12

  • 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
  • TMS Contraindications
  • Has ever had a seizure, or has a family history of epilepsy
  • Taking medications or substances that lower the seizure threshold
  • Implanted devices that are in the head or rely on physiological signals
  • History of neurological disease, such as stroke or brain tumor
  • Head injury with loss of consciousness greater than 30 minutes
  • Actively withdrawing from alcohol
  • Family history of schizophrenia or presence of psychotic symptoms

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Interventions

BEHAVIORALRealtime fMRI Neurofeedback - Active

fMRI aided reinforcement of craving regulation

DEVICETMS - Active

rTMS to right dorsolateral prefrontal cortex to reduce craving

BEHAVIORALRealtime fMRI Neurofeedback - Yoked Sham

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

DEVICETMS - Sham

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


Locations(1)

Auburn University

Auburn, Alabama, United States

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NCT05621538


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