aTBS for Treatment of Depression in AUD

Not Applicable

Withdrawn

• Conditions: Alcohol Use Disorder; Depression
• Interventions: Device: Accelerated theta burst treatment

• Registration Number: NCT03981185
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2019-01-12
• Study First Submitted QC: 2019-06-07
• Study First Posted: 2019-06-10
• Study Start: 2024-01-01
• Status Verified: 2024-07
• Primary Completion: 2024-07-11
• Study Completion: 2024-07-11
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated theta burst treatment	Accelerated theta burst treatment	All participants will receive theta-burst TMS.

Primary Outcome Measures

Name	Time	Method
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)	Baseline and 1 month post-stimulation	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

Name	Time	Method
Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)	Baseline and 1 month post-stimulation	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	At the beginning and end of each stimulation day	Heart rate variability will be measured using a NeuroConn device which involves electrodes being placed on the chest to record heart rate.
Change in functional connectivity from baseline as measured by MR imaging	Baseline and 1 month post-stimulation	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.