Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424184
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-05-10
Brief Title:
Accelerated rTMS for Substance Use Disorder and Depression
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Substance Use Disorder Treatment With Accelerated Repetitive Transcranial Magnetic Stimulation for Depression START-D
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is a small open-label feasibility trial of an accelerated course of repetitive transcranial magnetic stimulation rTMS for individuals with depression and stimulant use disorder including methamphetamine or cocaine use disorder MUDCUD
Detailed Description:
This research is an open label feasibility trial of accelerated course of repetitive transcranial magnetic stimulation rTMS for individuals with stimulant use disorder Participants will be recruited from an existing and ongoing longitudinal study of stimulant use disorder STIM-RAD NCT06073340 Prior to initiating the accelerated course of rTMS participants will undergo screening procedures to evaluate eligibility Those eligible will complete up to four 4 rTMS sessions of intermittent theta burst over left dorsolateral prefrontal cortex per day up to five 5 days per week of the study for a total of 50 sessions over a three 3 week period and will undergo electroencephalography EEG electrocardiography ECG urine drug screens as well as self-report and clinician-rated assessments A follow-up visit will be conducted 1 week after the last session of rTMS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None