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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Transcranial magnetic stimulation (TMS)

About this trial

This is an interventional basic science trial for Major Depressive Disorder focused on measuring Target engagement, TMS, Heart-brain pathway, Depression, Neuromodulation, DLPFC, Heart rate

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy
Between ages 18-60

Exclusion Criteria:

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

Sites / Locations

Research institute Brainclinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Left

Right

Arm Description

Subjects are ascribed to left hemispheric stimulation

Subjects are ascribed to right hemispheric stimulation

Outcomes

Primary Outcome Measures

Heart rate during stimulation, converted to RR intervals

Secondary Outcome Measures

Full Information

NCT ID

NCT03652597

First Posted

August 28, 2018

Last Updated

May 14, 2019

Sponsor

Utrecht University

Collaborators

Research institute Brainclinics

1. Study Identification

Unique Protocol Identification Number

NCT03652597

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

March 6, 2018 (Actual)

Primary Completion Date

May 2, 2019 (Actual)

Study Completion Date

May 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Utrecht University

Collaborators

Research institute Brainclinics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Target engagement, TMS, Heart-brain pathway, Depression, Neuromodulation, DLPFC, Heart rate

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Left

Arm Type

Active Comparator

Arm Description

Subjects are ascribed to left hemispheric stimulation

Arm Title

Right

Arm Type

Active Comparator

Arm Description

Subjects are ascribed to right hemispheric stimulation

Intervention Type

Device

Intervention Name(s)

Transcranial magnetic stimulation (TMS)

Intervention Description

Subjects receive TMS on several cortical brain locations, while recording the heart rate.

Primary Outcome Measure Information:

Title

Heart rate during stimulation, converted to RR intervals

Time Frame

2 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy Between ages 18-60 Exclusion Criteria: No prior experience with epilepsy No pregnancy No metal in the head No cochlear implants

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martijn Arns, Phd.

Organizational Affiliation

Research institute Brainclinics

Official's Role

Study Director

Facility Information:

Facility Name

Research institute Brainclinics

City

Nijmegen

State/Province

Gelderland

ZIP/Postal Code

6524AD

Country

Netherlands

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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