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

NCT ID: NCT03652597

Last Updated: 2019-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-06
• Study Completion Date: 2019-05-02

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. .

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Left

Subjects are ascribed to left hemispheric stimulation

Group Type: ACTIVE_COMPARATOR

Transcranial magnetic stimulation (TMS)

Intervention Type: DEVICE

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

Right

Subjects are ascribed to right hemispheric stimulation

Group Type: ACTIVE_COMPARATOR

Transcranial magnetic stimulation (TMS)

Intervention Type: DEVICE

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

Interventions

Transcranial magnetic stimulation (TMS)

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Research institute Brainclinics

UNKNOWN

Sponsor Role: collaborator

Utrecht University

OTHER

Sponsor Role: lead

Responsible Party

Tabitha Iseger

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martijn Arns, Phd.

Role: STUDY_DIRECTOR

Research institute Brainclinics

Locations

Research institute Brainclinics

Nijmegen, Gelderland, Netherlands

Countries

Netherlands

Other Identifiers

NL63092.041.17

Identifier Type: -

Identifier Source: org_study_id