Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06399406
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-04-30
Brief Title:
Mindfulness Engaged Neurostimulation for Depression
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Mindfulness Engaged Neurostimulation for Depression
Status:
RECRUITING
Status Verified Date:
2024-06
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:
MEND
Brief Summary:
Repetitive Transcranial Magnetic stimulation rTMS is an FDA-approved therapy for treatment resistant depression TRD that involves brief magnetic stimulation pulses on the dorsolateral prefrontal cortex DLPFC brain region But studies of rTMS alone show remission rates of 30 Additionally rTMS has not been shown to improve cognitive functioning that may be an independent factor predicting treatment success This study will develop a novel multimodal treatment which combines intermittent theta burst stimulation iTBS - a type of rTMS with digital mindfulness training to engage brain plasticity enhance cognition and alleviate depression symptoms in individuals with TRD
Detailed Description:
This study aims to develop a novel multimodal treatment for treatment resistant depression TRD which combines intermittent theta burst stimulation iTBS a type of FDA-approved rTMS protocol with digital mindfulness training We propose that this multimodal treatment will suppress posterior Default Mode Network pDMN brain activity as measured with electroencephalography primary outcome and neural target as well as enhance cognition and alleviate depression symptoms in patients with TRD The study will determine the optimal dose required for neural target engagement by the multimodal iTBS digital mindfulness training relative to an active control training combined with iTBS
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?:
None
Is an FDA AA801 Violation?:
None