Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06511544
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
rTMS to Target Neural Connectivity and Rumination in Treatment-Resistant Depression
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation of the Ventromedial Prefrontal Cortex to Target Neural Connectivity and Rumination in Treatment-Resistant Major Depressive Disorder A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if Transcranial Magnetic Stimulation TMS to part of the brain called the ventromedial prefrontal cortex VMPFC can treat a symptom called rumination in adults with major depression that has not responded to at least one medication trial The main question it aims to answer are
Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging fMRI during a negative self-referential processing task in adults with depression Does TMS to the VMPFC affect rumination in adults with depression Researchers will compare brain scans and rumination scores before during and immediately after TMS
Participants will
Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task
Does TMS to the VMPFC change brain activity on functional magnetic resonance imaging fMRI during a negative self-referential processing task in adults with depression Does TMS to the VMPFC affect rumination in adults with depression Researchers will compare brain scans and rumination scores before during and immediately after TMS
Participants will
Undergo three functional MRI scans Undergo a course of 20 TMS treatments Respond to clinical questionnaires and complete a computer behavioral task
Detailed Description:
This will be a single-site pilot open-label within-subject design study 20 participants with treatment-resistant depression defined as a failure to respond to at least one antidepressant medication trial within a current major depressive episode will be recruited Prior to intervention participants will undergo self-report and clinician-administered assessments in-person or virtual with both audio and video on using secure health telecommunication method as well as a fMRI during resting state and a self-referential processing task The baseline scan will also include a high-resolution structural sequence for neuronavigational purposes Then participants will receive 20 daily 5 daysweek sessions of rTMS to the VMPFC along with weekly assessments Participants will undergo a repeated fMRI scan early in the course of treatment after session 5 when we would expect neural changes to be evident but prior to any robust overall antidepressant effect as well as at the end of the rTMS course after session 20 Scores on the depression and rumination scales will be recorded prior to intervention and weekly thereafter Contact with subjects will be conducted once via telephone at two weeks after the end of study intervention as an adverse event assessment In the event that new or persistent adverse events felt to be related to the study intervention occur following the termination of study procedures subjects may be brought in for further safety assessments
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None