Cortical rTMS as a Tool to Change Brain Reactivity to Alcohol Cues

NCT02939313 | Completed Early Phase 1 DMC

• 2 other identifiers: 00050256P50AA010761
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this investigation is to determine if, in heavy alcohol users, a single session of transcranial magnetic brain stimulation (TMS) over a brain region involved in craving (medial prefrontal cortex) and a brain region involved in cogntive control (dorsolateral prefrontal cortex) can lower an individual's craving and brain response to alcohol cues. This study involves a screening visit, followed by three visits which involve brain imaging (using functional MRI) and brain stimulation (using TMS). There is also an additional Magnetic resonance spectroscopy (MRS) exploratory Aim in which we will measure the concentration of glutamate in the prefrontal cortex before and after a session of TMS.

Conditions

Alcohol Dependance

Keywords

alcohol; addiction; cTBS

Outcome Measures

Primary Outcomes (3)

• Percent signal change in the MPFC

  immediately after the treatment

• Percent signal change in the DLPFC

  immediately after the treatment

• Change in craving score

  immediately after the treatment

Secondary Outcomes (2)

• Change in glutmate concentration

  immediately after the treatment

• Change in GABA concentration

  immediately after the treatment

Study Arms (3)

medial prefrontal

EXPERIMENTAL

Individuals will receive medial prefrontal cortex stimulation

Device: medial prefrontal cortex

dorsolateral prefrontal

EXPERIMENTAL

Individuals will receive dorsolateral prefrontal cortex stimulation

Device: dorsolateral prefrontal cortex

sham

SHAM COMPARATOR

Individuals will receive sham stimulation to the medial prefrontal and dorsolateral prefrontal cortex

Device: sham

Interventions

medial prefrontal cortex DEVICE

a form of theta burst stimulation that noninvasively induces a depression in brain reactivity

Also known as: medial prefrontal

medial prefrontal

dorsolateral prefrontal cortex DEVICE

a form of transcranial magnetic stimulation that noninvasively induces an increase in brain reactivity

Also known as: dorsolateral prefrontal

dorsolateral prefrontal

sham DEVICE

sham stimulation

sham

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive Behavior; Impulsive Behavior; Behavior

Study Officials

• James Prisciandaro, Ph.D.

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: October 20, 2016
• Study Start: January 1, 2016
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)