Back to resultsaTBS for Treatment of Depression in AUD
Primary Purpose
Alcohol Use Disorder, Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Accelerated theta burst treatment
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder focused on measuring depression, TMS, transcranial magnetic stimulation, theta burst, alcohol use disorder, alcohol addiction
Eligibility Criteria
- Participant aged 18-65 years old with diagnosis of alcohol use disorder.
- Participant may also choose to or not to take pharmacotherapy during the study period.
- Participant has tried at least one medication in the past that has not helped the alcohol use disorder. If participants are taking medication, they must be on stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment.
- Participant needs to be at least one week after last alcohol/ substance use and had the last drink within one year of the beginning of the study participation.
- Participant endorses depressive symptom(s), indicated by a MARDS score >= 20.
- All participants must be assigned to a psychiatrist and agree to continue to be assigned to a psychiatrist throughout study enrollment.
- Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Accelerated theta burst treatment
Arm Description
All participants will receive theta-burst TMS.
Outcomes
Primary Outcome Measures
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Secondary Outcome Measures
Change in functional connectivity from baseline as measured by MR imaging
Pre- and post resting state functional connectivity and structural T1-weighted MRI scans to determine the anti-correlated LDLPFC and SCC treatment location. The identified cluster with the greatest anti-correlation between the LDLPFC and SCC will have been utilized for the targeted aiTBS treatment. This algorithm will have also been applied to the post-imaging sessions to give measurements of voxel-wise blood flow in this anti-correlation targeted brain ROI.
Change in functional connectivity from baseline as measured by MR imaging
Pre- and post resting state functional connectivity and structural T1-weighted MRI scans to determine the anti-correlated LDLPFC and SCC treatment location. The identified cluster with the greatest anti-correlation between the LDLPFC and SCC will have been utilized for the targeted aiTBS treatment. This algorithm will have also been applied to the post-imaging sessions to give measurements of voxel-wise blood flow in this anti-correlation targeted brain ROI.
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
OCDS is a 14-question self-rate tool to measure obsessive thoughts about alcohol and compulsive use of alcohol. The minimum obtainable score is 0, while the maximum obtainable score is 56. Higher scores represent a worse outcome.
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
OCDS is a 14-question self-rate tool to measure obsessive thoughts about alcohol and compulsive use of alcohol. The minimum obtainable score is 0, while the maximum obtainable score is 56. Higher scores represent a worse outcome.
Change in heart rate variability
Heart rate variability will be measured using a NeuroConn device which involves electrodes being placed on the chest to record heart rate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03981185
Brief Title
aTBS for Treatment of Depression in AUD
Official Title
Accelerated Theta Burst Stimulation for Treatment of Depression in Individuals With Detoxed Alcohol Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for improvement of depressive symptoms and drinking behavior in individuals with alcohol dependence. In this open label study, all participants will receive accelerated theta-burst stimulation.
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive procedure and an established technology. Research utilizing rTMS in patients with alcohol use disorder has shown some promising results. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters, such as using accelerated intermittent theta-burst stimulation (aiTBS), to reduce treatment times with possible enhanced efficacy with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Depression
Keywords
depression, TMS, transcranial magnetic stimulation, theta burst, alcohol use disorder, alcohol addiction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Accelerated theta burst treatment
Arm Type
Experimental
Arm Description
All participants will receive theta-burst TMS.
Intervention Type
Device
Intervention Name(s)
Accelerated theta burst treatment
Intervention Description
All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 80% of resting motor threshold adjust to the skull to cortical surface distance.
Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.
Primary Outcome Measure Information:
Title
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
Description
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Time Frame
Baseline and immediate post-stimulation
Title
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
Description
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
Time Frame
Baseline and 1 month post-stimulation
Secondary Outcome Measure Information:
Title
Change in functional connectivity from baseline as measured by MR imaging
Description
Pre- and post resting state functional connectivity and structural T1-weighted MRI scans to determine the anti-correlated LDLPFC and SCC treatment location. The identified cluster with the greatest anti-correlation between the LDLPFC and SCC will have been utilized for the targeted aiTBS treatment. This algorithm will have also been applied to the post-imaging sessions to give measurements of voxel-wise blood flow in this anti-correlation targeted brain ROI.
Time Frame
Baseline and immediate post-stimulation
Title
Change in functional connectivity from baseline as measured by MR imaging
Description
Pre- and post resting state functional connectivity and structural T1-weighted MRI scans to determine the anti-correlated LDLPFC and SCC treatment location. The identified cluster with the greatest anti-correlation between the LDLPFC and SCC will have been utilized for the targeted aiTBS treatment. This algorithm will have also been applied to the post-imaging sessions to give measurements of voxel-wise blood flow in this anti-correlation targeted brain ROI.
Time Frame
Baseline and 1 month post-stimulation
Title
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
Description
OCDS is a 14-question self-rate tool to measure obsessive thoughts about alcohol and compulsive use of alcohol. The minimum obtainable score is 0, while the maximum obtainable score is 56. Higher scores represent a worse outcome.
Time Frame
Baseline and immediate post-stimulation
Title
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)
Description
OCDS is a 14-question self-rate tool to measure obsessive thoughts about alcohol and compulsive use of alcohol. The minimum obtainable score is 0, while the maximum obtainable score is 56. Higher scores represent a worse outcome.
Time Frame
Baseline and 1 month post-stimulation
Title
Change in heart rate variability
Description
Heart rate variability will be measured using a NeuroConn device which involves electrodes being placed on the chest to record heart rate.
Time Frame
At the beginning and end of each stimulation day
Other Pre-specified Outcome Measures:
Title
Change from baseline in the Delis Kaplan Executive Function System (D-KEFS): Trail Making Test
Description
Delis Kaplan Executive Function System (D-KEFS): Trail Making Test Description: The Trail Making Test was used to measure combined visuomotor and executive functioning including sequencing and cognitive switching. The test also provides measures of visual scanning and motor speed.
Reference: DELIS DC, KRAMER JH, KAPLAN E, HOLDNACK J. Reliability and validity of the Delis-Kaplan Executive Function System: An update. J Int Neuropsychol Soc. 2004;10(02)
Time Frame
Baseline and immediate post-stimulation
Title
Change from baseline in the Delis Kaplan Executive Function System (D-KEFS): Trail Making Test
Description
Delis Kaplan Executive Function System (D-KEFS): Trail Making Test Description: The Trail Making Test was used to measure combined visuomotor and executive functioning including sequencing and cognitive switching. The test also provides measures of visual scanning and motor speed.
Reference: DELIS DC, KRAMER JH, KAPLAN E, HOLDNACK J. Reliability and validity of the Delis-Kaplan Executive Function System: An update. J Int Neuropsychol Soc. 2004;10(02)
Time Frame
Baseline and 1 month post-stimulation
Title
Change from baseline in the Hopkins Verbal Learning Test- Revised (HVLT-R)
Description
The Hopkins Verbal Learning Test - Revised (HVLT-R) is given to assess learning and recall of verbal information. The HVLT-R is a list-learning task with three learning trials, a 20-minute delayed recall, and a recognition paradigm following the delayed recall. There are six alternate forms that allow for serial evaluation.
Time Frame
Baseline and immediate post-stimulation
Title
Change from baseline in the Hopkins Verbal Learning Test- Revised (HVLT-R)
Description
The Hopkins Verbal Learning Test - Revised (HVLT-R) is given to assess learning and recall of verbal information. The HVLT-R is a list-learning task with three learning trials, a 20-minute delayed recall, and a recognition paradigm following the delayed recall. There are six alternate forms that allow for serial evaluation.
Time Frame
Baseline and 1 month post-stimulation
Title
Change from baseline in the Brief Visuospatial Memory Test - Revised (BVMT-R)
Description
The Brief Visuospatial Memory Test - Revised (BVMT-R) is given to measure learning and memory of visuospatial stimuli. The BVMT-R is a task that requires the participant to learn an array of simple geometric figures over three learning trials. There is a delayed recall after 25 minutes and a recognition task following the delay. There is also a copy task following the memory recall and recognition portions of the test. There are six alternate forms that allow for serial evaluation.
Time Frame
Baseline and immediate post-stimulation
Title
Change from baseline in the Brief Visuospatial Memory Test - Revised (BVMT-R)
Description
The Brief Visuospatial Memory Test - Revised (BVMT-R) is given to measure learning and memory of visuospatial stimuli. The BVMT-R is a task that requires the participant to learn an array of simple geometric figures over three learning trials. There is a delayed recall after 25 minutes and a recognition task following the delay. There is also a copy task following the memory recall and recognition portions of the test. There are six alternate forms that allow for serial evaluation.
Time Frame
Baseline and 1-month post-stimulation
Title
Change from baseline in the Advanced Clinical Solutions Test of Premorbid Function (TOPF)
Description
The Advanced Clinical Solutions Test of Premorbid Function (TOPF) is given to estimate an individual's premorbid cognitive and memory functioning. Although TOPF is not impervious to the effects of cognitive dysfunction, it appears to be less affected than other measures of intellectual and memory functioning. The TOPF is based on a reading paradigm, requiring the reading and pronunciation of words that have irregular grapheme-to-phoneme translation. It does not require comprehension or knowledge of word meaning.
Time Frame
Baseline and immediate post-stimulation
Title
Change from baseline in the Advanced Clinical Solutions Test of Premorbid Function (TOPF)
Description
The Advanced Clinical Solutions Test of Premorbid Function (TOPF) is given to estimate an individual's premorbid cognitive and memory functioning. Although TOPF is not impervious to the effects of cognitive dysfunction, it appears to be less affected than other measures of intellectual and memory functioning. The TOPF is based on a reading paradigm, requiring the reading and pronunciation of words that have irregular grapheme-to-phoneme translation. It does not require comprehension or knowledge of word meaning.
Time Frame
Baseline and 1-month post-stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Participant aged 18-65 years old with diagnosis of alcohol use disorder.
Participant may also choose to or not to take pharmacotherapy during the study period.
Participant has tried at least one medication in the past that has not helped the alcohol use disorder. If participants are taking medication, they must be on stable psychotropic medication or psychotherapy for at least 6 weeks prior to the study with plans to continue throughout study enrollment.
Participant needs to be at least one week after last alcohol/ substance use and had the last drink within one year of the beginning of the study participation.
Participant endorses depressive symptom(s), indicated by a MARDS score >= 20.
All participants must be assigned to a psychiatrist and agree to continue to be assigned to a psychiatrist throughout study enrollment.
Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Romina Nejad, MSc
Phone
650-497-3933
Email
rnejad@stanford.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Huiqiong Deng, MD, PhD
Phone
650-498-7430
Email
hdeng397@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nolan Williams, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
aTBS for Treatment of Depression in AUD
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