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The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder (MAGNA)

Primary Purpose

Alcohol Use Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

active rTMS

Inpatient admission

sham rTMS

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring rTMS, alcohol use disorder

Eligibility Criteria

22 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Current moderate to severe alcohol use disorder, per DSM-5
Use of alcohol which parallels or exceeds the amount alcohol that will be administered in this study (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour).
Age 22-55
Able to give informed consent, and comply with study procedures
Medically healthy, with the absence of current or past medical or neurological illnesses (including glaucoma, increased intracranial pressure, liver disease, cardiac disease, or seizure disorders)

Exclusion Criteria:

Has a contraindication to MRI, such as magnetically reactive implants, which includes metal in head except in mouth (cochlear implant, implanted brain stimulators, aneurysm clips), cardiac pacemakers, implanted neurostimulators and medication pumps, and intracardiac lines.
Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary
Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation.
History of seizures of any type
A family history of epilepsy
Taking psychotropic medication that would affect resting motor threshold (such as anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of neuroleptics)
Current suicide risk or a history of suicide attempt within the past 2 years
Have unstable physical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension (a resting blood pressure > 140/90), heart failure, a recent history of myocardial infarction, previous stroke, brain lesions, any history of seizures under any circumstances or low hemoglobin.
Currently pregnant
History of severe alcohol withdrawal requiring medical care, such as withdrawal seizures, delirium tremens, withdrawal necessitating medical detoxification.
A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA approved medications for AUD

Sites / Locations

New York State Psychiatric InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Stimulation

Sham Stimulation

Arm Description

Participants will be receiving active rTMS.

Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.

Outcomes

Primary Outcome Measures

Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session.

Participants will participate in alcohol self-administration sessions in which they are presented with the choice of alcohol or money. The investigators will study the change in choices to choose alcohol during these sessions. There will be one session prior to rTMS and one after 3 weeks of rTMS.

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.

Adverse events will be assessed in recorded in accordance with CTCAE v4.0.

Secondary Outcome Measures

Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).

This AUQ (Bohn et al. 1995) is an 8-item self report questionnaire where participants rate a seven-point Likert scale with responses ranging from "strongly disagree" to "strongly agree", and a total score is derived from the sum of these items following reverse scoring of two items. A lower score is a better outcome which represents less desire to drink. Scores range from 8-56.

Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).

MRS is performed by using an MRI machine to study metabolites and neurotransmitters in the brain.

Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.

Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).

The FAB is a brief tool that discriminates between frontal-temporal type cognitive issues from from Alzheimer's type memory issues. Higher scores are better and scores range from 0-18.

Full Information

NCT ID

NCT03809286

First Posted

January 9, 2019

Last Updated

November 3, 2022

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

1. Study Identification

Unique Protocol Identification Number

NCT03809286

Brief Title

The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder

Acronym

MAGNA

Official Title

The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 24, 2019 (Actual)

Primary Completion Date

December 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York State Psychiatric Institute

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study is to investigate a treatment approach for alcohol use disorder (AUD) using a novel form of brain stimulation called deep repetitive transcranial magnetic stimulation (rTMS). The investigators will be targeting frontal regions of the brain that are important for memory and decision making. These brain regions have been shown to be impaired in patients with AUD. Previous studies have mostly used rTMS to a different frontal brain region that is not as deep. These studies have shown that rTMS can reduce craving for alcohol, but there is a lack of research showing that rTMS impacts alcohol consumption.

Detailed Description

This study aims to examine the effect of rTMS on alcohol drinking behavior in an observed laboratory setting. Participants with AUD will be recruited and admitted to the inpatient unit for the whole study. After a brief detoxification period, they will receive 3 weeks of rTMS while in the research unit. Before and after the 3 weeks of stimulation, participants will participate in a decision-making experiment where they can choose to have an alcoholic drink or the equivalent amount of money that the drink would cost (alcohol self-administration sessions). The investigators will examine their response to alcohol, as well as their performance on tasks that relate to impulsivity and memory. Participants will also undergo an MRI scan (with spectroscopy) before and after the stimulation period to look at changes in the medial prefrontal cortex of the brain. Participants will then meet with a study physician for 6 weeks after the study for assessments of alcohol use and medical management sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcohol Use Disorder

Keywords

rTMS, alcohol use disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

active vs. sham stimulation

Masking

ParticipantCare ProviderInvestigator

Masking Description

double-blind

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active Stimulation

Arm Type

Experimental

Arm Description

Participants will be receiving active rTMS.

Arm Title

Sham Stimulation

Arm Type

Sham Comparator

Arm Description

Participants will be receiving sham stimulation with a smaller coil housed within the rTMS device.

Intervention Type

Device

Intervention Name(s)

active rTMS

Intervention Description

rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.

Intervention Type

Behavioral

Intervention Name(s)

Inpatient admission

Intervention Description

All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.

Intervention Type

Device

Intervention Name(s)

sham rTMS

Intervention Description

The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.

Primary Outcome Measure Information:

Title

Change in the choice to self-administer alcohol in the laboratory as assessed by counting the number of drinks consumed in the 2-hour laboratory session.

Description

Time Frame

4 weeks

Title

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0.

Description

Adverse events will be assessed in recorded in accordance with CTCAE v4.0.

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Change in craving for alcohol measured using the Alcohol Urge Questionnaire (AUQ).

Description

Time Frame

4 weeks

Title

Change in GABA in the mPFC and ACC as measured with magnetic resonance spectroscopy (MRS).

Description

MRS is performed by using an MRI machine to study metabolites and neurotransmitters in the brain.

Time Frame

4 weeks

Title

Change in abstinence from alcohol following discharge assessed with the Time Line Follow Back Interview.

Time Frame

10 weeks

Title

Changes in cognitive control as measured by using the Frontal Assessment Battery (FAB).

Description

The FAB is a brief tool that discriminates between frontal-temporal type cognitive issues from from Alzheimer's type memory issues. Higher scores are better and scores range from 0-18.

Time Frame

4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Current moderate to severe alcohol use disorder, per DSM-5 Use of alcohol which parallels or exceeds the amount alcohol that will be administered in this study (1 drinking episode per week raising BAL to 0.03 g/dl - approximately 2 drinks within an hour). Age 22-55 Able to give informed consent, and comply with study procedures Medically healthy, with the absence of current or past medical or neurological illnesses (including glaucoma, increased intracranial pressure, liver disease, cardiac disease, or seizure disorders) Exclusion Criteria: Has a contraindication to MRI, such as magnetically reactive implants, which includes metal in head except in mouth (cochlear implant, implanted brain stimulators, aneurysm clips), cardiac pacemakers, implanted neurostimulators and medication pumps, and intracardiac lines. Substance use disorder with substances other than alcohol or nicotine. The current use of sedative-hypnotics or opiates will be exclusionary Meets DSM-5 criteria for other psychiatric illness, such as major depression, that would interfere with participation. History of seizures of any type A family history of epilepsy Taking psychotropic medication that would affect resting motor threshold (such as anticonvulsants) or increase risk of seizure (especially tricyclic antidepressants of neuroleptics) Current suicide risk or a history of suicide attempt within the past 2 years Have unstable physical disorders, including those that are previously undiagnosed, untreated, inadequately treated, or active to an extent which might make participation hazardous. For example, hypertension (a resting blood pressure > 140/90), heart failure, a recent history of myocardial infarction, previous stroke, brain lesions, any history of seizures under any circumstances or low hemoglobin. Currently pregnant History of severe alcohol withdrawal requiring medical care, such as withdrawal seizures, delirium tremens, withdrawal necessitating medical detoxification. A desire to pursue standard treatment for AUD, such as a rehabilitation program or FDA approved medications for AUD

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jonathan Wai, MD

Phone

646-774-7654

jonathan.wai@nyspi.columbia.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Wai

Organizational Affiliation

New York State Psychiatric Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York State Psychiatric Institute

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jonathan Wai

12. IPD Sharing Statement

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The Effect of rTMS to the Prefrontal Cortex in Alcohol Use Disorder

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