Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: Replication and Dose-response.
1 other identifier
interventional
50
1 country
1
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. .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable major-depressive-disorder
Started Mar 2018
Shorter than P25 for not_applicable major-depressive-disorder
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 6, 2018
CompletedFirst Submitted
Initial submission to the registry
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 29, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 2, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 2, 2019
CompletedMay 15, 2019
May 1, 2019
1.2 years
August 28, 2018
May 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Heart rate during stimulation, converted to RR intervals
2 weeks
Study Arms (2)
Left
ACTIVE COMPARATORSubjects are ascribed to left hemispheric stimulation
Right
ACTIVE COMPARATORSubjects are ascribed to right hemispheric stimulation
Interventions
Subjects receive TMS on several cortical brain locations, while recording the heart rate.
Eligibility Criteria
You may qualify if:
- Healthy
- Between ages 18-60
You may not qualify if:
- No prior experience with epilepsy
- No pregnancy
- No metal in the head
- No cochlear implants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Utrecht Universitylead
- Research institute Brainclinicscollaborator
Study Sites (1)
Research institute Brainclinics
Nijmegen, Gelderland, 6524AD, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Martijn Arns, Phd.
Research institute Brainclinics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
August 28, 2018
First Posted
August 29, 2018
Study Start
March 6, 2018
Primary Completion
May 2, 2019
Study Completion
May 2, 2019
Last Updated
May 15, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share