Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03652597
Status:
COMPLETED
Last Update Posted:
2019-05-15
First Post:
2018-08-28
Brief Title:
Neuro-Cardiac-Guided Transcranial Magnetic Stimulation Replication and Dose-response
Sponsor:
Utrecht University
Organization:
Utrecht University
Study Overview
Official Title:
Neuro-Cardiac-Guided Transcranial Magnetic Stimulation a Method to Probe the Depression Network Replication and Dose-response
Status:
COMPLETED
Status Verified Date:
2019-05
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:
Autonomic regulation is disturbed in patients with major depressive disorder MDD indicated by a higher heart rate HR and lower heart rate variability HRV Moreover the heart seems to be functionally connected via the vagus nerve VN to other brain structures that are dysregulated in depression such as the subgenual anterior cingulate cortex sgACC and the dorsolateral prefrontal cortex DLPFC suggesting dysregulated network function in MDD In line with this network dysregulation hypothesis of MDD optimal transcranial magnetic stimulation TMS sites are currently thought to be those that show functional connectivity to the sgACC such as the DLPFC and multiple studies have shown that stimulation of the DLPFC sgACC and nervus vagus decreased heart rate suggestive of parasymphatetic action It is hypothesized that this influence on parasympathetic activity can be used as a functional outcome measure reflecting adequate targeting of the DLPFC-sgACC network similar to the motor evoked potential MEP as functional key measure for primary motor cortex stimulation Recently a pilot study was conducted proposing a new functional neuronavigation method for localizing the frontal area representation of DLPFC-sgACC connectivity using HR called Neuro-Cardiac-Guided TMS NCG-TMS which is being replicated in the current study
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None