Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: Replication and Dose-response.

Major Depressive Disorder Clinical Trial

Official title:

Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: a Method to Probe the Depression Network. Replication and Dose-response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03652597
• Other study ID #: NL63092.041.17
• Status: Completed
• Phase: N/A
• Start date: March 6, 2018
• Est. completion date: May 2, 2019

Study information

• Verified date: May 2019
• Source: Utrecht University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2, 2019
• Est. primary completion date: May 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy

• Between ages 18-60

Exclusion Criteria:

• No prior experience with epilepsy

• No pregnancy

• No metal in the head

• No cochlear implants

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Transcranial magnetic stimulation (TMS)
Subjects receive TMS on several cortical brain locations, while recording the heart rate.

Locations

Country	Name	City	State
Netherlands	Research institute Brainclinics	Nijmegen	Gelderland

Sponsors (2)

Lead Sponsor	Collaborator
Utrecht University	Research institute Brainclinics

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate during stimulation, converted to RR intervals		2 weeks