A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
NCT ID: NCT05621538
Last Updated: 2025-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
90 participants
INTERVENTIONAL
2025-10-01
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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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)
Realtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation
TMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving
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)
Realtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation
TMS - Sham
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
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)
TMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving
Realtime fMRI Neurofeedback - Yoked Sham
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
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)
Realtime fMRI Neurofeedback - Yoked Sham
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
TMS - Sham
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Check-In Only
4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)
No interventions assigned to this group
Interventions
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Realtime fMRI Neurofeedback - Active
fMRI aided reinforcement of craving regulation
TMS - Active
rTMS to right dorsolateral prefrontal cortex to reduce craving
Realtime fMRI Neurofeedback - Yoked Sham
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
TMS - Sham
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Receiving treatment for Alcohol Use Disorder
Exclusion Criteria
1. Presence of metal in the body that would make having a 7T MRI unsafe (including facial tattoos)
2. Claustrophobia, such that individual would be unable to stay in the MRI for up to 1 hr
3. Hearing loss, including tinnitus, that might be made worse by MRI or TMS
2. TMS Contraindications
1. Has ever had a seizure, or has a family history of epilepsy
2. Taking medications or substances that lower the seizure threshold
3. Implanted devices that are in the head or rely on physiological signals
4. History of neurological disease, such as stroke or brain tumor
5. Head injury with loss of consciousness greater than 30 minutes
6. Actively withdrawing from alcohol
3. Family history of schizophrenia or presence of psychotic symptoms
19 Years
65 Years
ALL
No
Sponsors
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)
NIH
Auburn University
OTHER
Responsible Party
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Samantha Fede
Assistant Professor
Principal Investigators
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Samantha J Fede, PhD
Role: PRINCIPAL_INVESTIGATOR
Auburn University
Locations
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Auburn University
Auburn, Alabama, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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22145
Identifier Type: -
Identifier Source: org_study_id
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