Health TrialsbyHealthPanel

Assessing the Impact of dTMS on Neural Targets Associated With Alcohol Use Disorder

ConditionsAlcohol Use Disorder (AUD)Transcranial Magnetic Stimilation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorStanford University

About this trial

The purpose of this study is to evaluate the efficacy of deep transcranial magnetic stimulation as a treatment for Veterans with Alcohol Use Disorder (AUD) to decrease the exceedingly high rate of relapse associated with this condition.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75.

Current DSM-5 diagnosis of moderate to severe AUD (≥4 diagnostic symptoms).

Ability to obtain a Motor Threshold (MT) will be determined during the screening process.

Has an adequately stable condition and environment to enable attendance at scheduled clinic visits.

Disqualifiers

Transcranial magnetic stimulation (TMS) and magnetic resonance imaging (MRI) contraindications: such as a cardiac pacemaker, cochlear implant, or an implanted device (deep brain stimulation, metal in the head, metal in the body, claustrophobia, pregnant or breastfeeding or other ferromagnetic device/objected in the head and body within 30 cm of the treatment coil.

General medical condition, disease or neurological disorder that interferes with the assessments or participation.

Unable to safely withdraw, at least two weeks prior to treatment, from medications that increase seizure risk.

Current substance abuse (except caffeine or nicotine) as determined by positive toxicology screen.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Active

    Device

    The study will utilize the H7 coil to administer active Deep Transcranial Magnetic Stimulation (dTMS) to the dorsal anterior cingulate cortex (dACC), a core salience network node.

  • Deep Transcranial Magnetic Stimulation (dTMS) H7 coil - Sham

    Device

    The study will utilize an identical protocol using the H7 coil to administer a sham condition.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active dTMSExperimental treatment 1 intervention
Group B: Sham dTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Dorsal Anterior Cingulate Cortex Function (dACC) Activation During the FACES Task, Measured via fMRI

dACC activation to threat faces will be measured using fMRI during the FACES task, designed to assess emotional processing. Activation will be quantified as percent signal change from baseline (pre-treatment) to post-treatment scan.

Time frame
1-4 days post treatment
2

Percentage of Days Abstinent from Alcohol, Assessed by Timeline Followback (TLFB)

Alcohol abstinence will be assessed using the TLFB structured interview method. The outcome will be calculated as the percentage of alcohol-free days out of the total number of days in the 3-month follow-up period post-treatment.

Time frame
3-months post treatment
3

Percentage of Heavy Drinking Days, Assessed by Timeline Followback (TLFB)

Heavy drinking days are defined as ≥5 drinks/day for men and ≥4 drinks/day for women within a 2-hour period. Self-reported data via TLFB used to calculate the percentage of heavy drinking days during the 3-month follow-up treatment.

Time frame
3 months post-treatment

Secondary outcomes

1

Change in Salience Network Functional Connectivity During FACES Task, Measured via fMRI

Functional connectivity between the dACC and prefrontal cortex (PFC) will be assessed using fMRI during the FACES Task. Connectivity strength will be calculated using psychophysiological interaction (PPI) analysis or similar methods.

Time frame
1-4 days post treatment
2

Change in Resting-State Salience Network Activation, Measured via fMRI

Resting-state fMRI will assess dACC activation. Measures will include percent signal change pre- to post-treatment.

Time frame
1-4 days post-treatment
3

Change in Resting-State Salience Network Functional Connectivity, Measured via fMRI

Resting-state functional connectivity between the dACC and prefrontal cortex (PFC) will be measured using CONN.

Time frame
1-4 days post treatment
4

Relapse Status, assessed by Timeline Followback (TLFB)

Relapse will be defined as any alcohol use following the post-treatment period, assessed using TLFB. Outcome will be reported as a binary (yes/no) variable.

Time frame
3 months post-treatment

Other outcomes

Sponsors and contacts

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

Stanford University

Lead sponsor

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Source ClinicalTrials.gov
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