search
Back to results

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder (CNT)

Primary Purpose

Alcohol Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Realtime fMRI Neurofeedback - Active
TMS - Active
Realtime fMRI Neurofeedback - Yoked Sham
TMS - Sham
Sponsored by
Auburn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Use Disorder focused on measuring treatment seeking, alcohol, TMS, neurofeedback, supplemental intervention, heavy drinking, problems with drinking

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age 19-65 Receiving treatment for Alcohol Use Disorder Exclusion Criteria: 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

Sites / Locations

  • Auburn University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

No Intervention

Arm Label

Neurofeedback-active + TMS-active

Neurofeedback-active + TMS-sham

Neurofeedback-sham + TMS-active

Neurofeedback-sham + TMS-sham

Check-In Only

Arm Description

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)

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)

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)

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)

4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)

Outcomes

Primary Outcome Measures

Change in Alcohol Use over Time
Alcohol Timeline Followback (alc-TLFB)
Change in Alcohol Craving over Time
Alcohol Craving Questionnaire (ACQ)
Change in Community Functioning over Time
Drinker Inventory of Consequences (DrInC)
Change in Employment Status over Time
self-reported employment status
Change in Aggression and Victimization over Time
Revised Conflict Tactics Scales (CTS-R)
Change in Antisocial Behavior over Time
number of self-reported contacts with the police, convictions, and other criminal behaviors
Change in Brain Activity during Alcohol Cue Presentation over Time
Measured via fMRI; standard alcohol cue reactivity
Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time
Measured via fMRI; alcohol-cued sociomoral processing

Secondary Outcome Measures

Change in Brain Gray Matter Structure over Time
Measured via MRI; gray matter volume
Change in Brain White Matter Structure over Time
Measured via MRI; white matter diffusion
Change in Resting State Functional Connectivity over Time
Measured via fMRI

Full Information

First Posted
October 26, 2022
Last Updated
November 10, 2022
Sponsor
Auburn University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05621538
Brief Title
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Acronym
CNT
Official Title
A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Auburn University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder
Keywords
treatment seeking, alcohol, TMS, neurofeedback, supplemental intervention, heavy drinking, problems with drinking

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
The PI will prospectively assign treatment groups with blind codes and so will not be blind to treatment type. Other staff, who are the individuals primarily working with the patients and who will be conducting follow-up interviews, will be blind to treatment type. It is not possible to blind the 5th condition (treatment as usual with a brief check-in).
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback-active + TMS-active
Arm Type
Experimental
Arm Description
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)
Arm Title
Neurofeedback-active + TMS-sham
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Neurofeedback-sham + TMS-active
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Neurofeedback-sham + TMS-sham
Arm Type
Sham Comparator
Arm Description
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)
Arm Title
Check-In Only
Arm Type
No Intervention
Arm Description
4 sessions of: Completing typical pre-TMS/MRI procedures Being prompted to reflect on outside treatment (TAU)
Intervention Type
Behavioral
Intervention Name(s)
Realtime fMRI Neurofeedback - Active
Intervention Description
fMRI aided reinforcement of craving regulation
Intervention Type
Device
Intervention Name(s)
TMS - Active
Other Intervention Name(s)
Magventure Magpro
Intervention Description
rTMS to right dorsolateral prefrontal cortex to reduce craving
Intervention Type
Behavioral
Intervention Name(s)
Realtime fMRI Neurofeedback - Yoked Sham
Intervention Description
Display of feedback from other participant's sessions to serve as a sham for fMRI aided reinforcement of craving regulation
Intervention Type
Device
Intervention Name(s)
TMS - Sham
Intervention Description
rTMS using placebo coil (no brain stimulation, emulates other features of active TMS), placed over right dorsolateral prefrontal cortex
Primary Outcome Measure Information:
Title
Change in Alcohol Use over Time
Description
Alcohol Timeline Followback (alc-TLFB)
Time Frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Title
Change in Alcohol Craving over Time
Description
Alcohol Craving Questionnaire (ACQ)
Time Frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions, pre and post), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Title
Change in Community Functioning over Time
Description
Drinker Inventory of Consequences (DrInC)
Time Frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Title
Change in Employment Status over Time
Description
self-reported employment status
Time Frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 33, 37, 41, 45, 49, 53 (follow-ups)
Title
Change in Aggression and Victimization over Time
Description
Revised Conflict Tactics Scales (CTS-R)
Time Frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Title
Change in Antisocial Behavior over Time
Description
number of self-reported contacts with the police, convictions, and other criminal behaviors
Time Frame
Assessed at weeks: 1 (baseline), 2-5 (intervention sessions), 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 53, 57 (follow-ups)
Title
Change in Brain Activity during Alcohol Cue Presentation over Time
Description
Measured via fMRI; standard alcohol cue reactivity
Time Frame
Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Title
Change in Brain Activity during Simultaneous Sociomoral & Alcohol Cue Presentation over Time
Description
Measured via fMRI; alcohol-cued sociomoral processing
Time Frame
Assessed at weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Secondary Outcome Measure Information:
Title
Change in Brain Gray Matter Structure over Time
Description
Measured via MRI; gray matter volume
Time Frame
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Title
Change in Brain White Matter Structure over Time
Description
Measured via MRI; white matter diffusion
Time Frame
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)
Title
Change in Resting State Functional Connectivity over Time
Description
Measured via fMRI
Time Frame
Weeks: 1 (baseline), 5 (post final intervention), 29 and 57 (follow-ups)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 19-65 Receiving treatment for Alcohol Use Disorder Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SCAMPI Lab
Phone
334-521-2807
Email
scampi@auburn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samantha J Fede, PhD
Organizational Affiliation
Auburn University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auburn University
City
Auburn
State/Province
Alabama
ZIP/Postal Code
36849
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SCAMPI Lab
Phone
334-521-2807
Email
scampi@auburn.edu
First Name & Middle Initial & Last Name & Degree
Samantha J Fede, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared within the NIAAA Data Archive according to the standard data sharing plan. Deidentified individual data regarding the outcome variables (clinical and MRI) will be included. Participants will have the option to opt out of sharing their individual data. Given the highly sensitive and confidential nature of the information, and the magnitude of potential harms to participants associated with disclosure, clinical outcome data pertaining to criminal acts and illegal activities will not be available in the data repository.

Learn more about this trial

A Combined Neurofeedback-TMS Intervention for Alcohol Use Disorder

We'll reach out to this number within 24 hrs