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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03652597
Recruitment Status : Completed
First Posted : August 29, 2018
Last Update Posted : May 15, 2019
Research institute Brainclinics
Information provided by (Responsible Party):
Tabitha Iseger, 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. .

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Transcranial magnetic stimulation (TMS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: a Method to Probe the Depression Network. Replication and Dose-response
Actual Study Start Date : March 6, 2018
Actual Primary Completion Date : May 2, 2019
Actual Study Completion Date : May 2, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Left
Subjects are ascribed to left hemispheric stimulation
Device: Transcranial magnetic stimulation (TMS)
Subjects receive TMS on several cortical brain locations, while recording the heart rate.

Active Comparator: Right
Subjects are ascribed to right hemispheric stimulation
Device: Transcranial magnetic stimulation (TMS)
Subjects receive TMS on several cortical brain locations, while recording the heart rate.

Primary Outcome Measures :
  1. Heart rate during stimulation, converted to RR intervals [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy
  • Between ages 18-60

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03652597

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Research institute Brainclinics
Nijmegen, Gelderland, Netherlands, 6524AD
Sponsors and Collaborators
Utrecht University
Research institute Brainclinics
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Study Director: Martijn Arns, Phd. Research institute Brainclinics

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Responsible Party: Tabitha Iseger, Principal investigator, Utrecht University Identifier: NCT03652597    
Other Study ID Numbers: NL63092.041.17
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tabitha Iseger, Utrecht University:
Target engagement
Heart-brain pathway
Heart rate
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders