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

U

Utrecht University

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Device: Transcranial magnetic stimulation (TMS)

Study type

Interventional

Funder types

Other

Identifiers

NCT03652597
NL63092.041.17

Details and patient eligibility

About

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. .

Enrollment

50 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Left
Active Comparator group
Description:
Subjects are ascribed to left hemispheric stimulation
Treatment:
Device: Transcranial magnetic stimulation (TMS)
Right
Active Comparator group
Description:
Subjects are ascribed to right hemispheric stimulation
Treatment:
Device: Transcranial magnetic stimulation (TMS)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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