Accelerated Theta Burst Stimulation for Treatment of Depression in Individuals With Detoxed Alcohol Use Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Stanford University
- Primary Endpoint
- Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change from baseline Montgomery Asberg Depression Rating Scale (MADRS)
Time Frame: 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 Outcomes
- Change in alcohol craving and consumption measured by Obsessive Compulsive Drinking Scale (OCDS)(Baseline and 1 month post-stimulation)
- Change in heart rate variability(At the beginning and end of each stimulation day)
- Change in functional connectivity from baseline as measured by MR imaging(Baseline and 1 month post-stimulation)
Investigators
Gregory Sahlem
Assistant Professor
Stanford University