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NCT03652597
Neuro-Cardiac-Guided Transcranial Magnetic Stimulation: Replication and Dose-response.
NA trial testing Transcranial magnetic stimulation (TMS) in Major Depressive Disorder in 50 participants. Completed in 2 May 2019.
2 May 2019
Quick facts
| Lead sponsor | Utrecht University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 50 |
| Start date | 6 March 2018 |
| Primary completion | 2 May 2019 |
| Estimated completion | 2 May 2019 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Transcranial magnetic stimulation (TMS)
Conditions studied
- Major Depressive Disorder — all drugs for Major Depressive Disorder →
Sponsor
Utrecht University
Who can join
Adults 18 to 60, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. .
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03652597
- Europe PMC full search
- ASCO Meeting Library
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- bioRxiv preprints
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Related trials
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Trials testing the same drug.
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- NCT05829005 — Trial Of Neurostimulation Treatment and Investigation for Causes of Functional Motor Symptoms: a Pilot Study · NA · completed
- NCT05713721 — Sensorimotor Integration in Monogenic Parkinson-dystonia Syndromes · unknown
Other recruiting trials for Major Depressive Disorder
Currently open trials in the same condition.
- NCT07219394 — Peer-Delivered Behavioral Activation in a CCBHC · NA · recruiting
- NCT06705478 — Pramipexole Versus Escitalopram to Treat Major Depressive Disorder (MDD) and Comorbid MDD With Mild Neurocognitive Disor · Phase 2 · recruiting
- NCT06749392 — An Individual-specific Synchrony Signature · NA · recruiting
- NCT07316803 — Group Intervention for Romantic Relationships in Young Adults With Severe Mental Illness · NA · recruiting
- NCT07242105 — Optimizing Brain Excitability in Depression · NA · recruiting
Other Utrecht University trials
Trials by the same sponsor.
- NCT07157761 — The Effectiveness of a Dutch Program in Preventing Criminal Exploitation · NA · recruiting
- NCT05891067 — The Effectiveness of a Classroom-based Intervention Promoting a Prosocial Classroom Climate in Children · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03652597 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Utrecht University
- Last refreshed: 15 May 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03652597.
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