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

Not Applicable

Completed

• Conditions: Major Depressive Disorder
• Interventions: Device: Transcranial magnetic stimulation (TMS)

• Registration Number: NCT03652597
• Lead Sponsor: Utrecht University

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

Not available

Study Timeline

• Study Start: 2018-03-06
• Study First Submitted: 2018-08-28
• Study First Submitted QC: 2018-08-28
• Study First Posted: 2018-08-29
• Status Verified: 2019-05
• Primary Completion: 2019-05-02
• Study Completion: 2019-05-02
• Last Update Submitted: 2019-05-14
• Last Update Posted: 2019-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Healthy
• Between ages 18-60

Exclusion Criteria

• No prior experience with epilepsy
• No pregnancy
• No metal in the head
• No cochlear implants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Left	Transcranial magnetic stimulation (TMS)	Subjects are ascribed to left hemispheric stimulation
Right	Transcranial magnetic stimulation (TMS)	Subjects are ascribed to right hemispheric stimulation

Primary Outcome Measures

Name	Time	Method
Heart rate during stimulation, converted to RR intervals	2 weeks

Trial Locations

Locations (1)

Research institute Brainclinics; 🇳🇱 Nijmegen, Gelderland, Netherlands