Clinical Trials Logo

Clinical Trial Summary

Healthy controls (HC) will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single MRI session and will then participate in an on-line neuro-navigation session in which various TMS coil positions will be recorded. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample.


Clinical Trial Description

HC subjects (n=10)/yr will be studied once to provide data needed to validate the virtual neuro-navigation system. All subjects will undergo a single Human Connectome Project compatible MRI session permitting application of both surface-based and more standard volumetric analyses. Subjects will then participate in an on-line neuro-navigation session in which TMS coil positions (in 10/20 coordinate space) will be recorded corresponding to the following targets: 1) hand-representation of motor strip; 2) 5-cm location; 3) 5.5 cm location; 4) MNI coordinates corresponding to the "Fitzgerald"4 and "Weigand"6 volumetric targets; 5) peak anti-correlated region (calculated from rsfcfMRI data alone); 6) center of our targeted parcel, calculated using surface-based approaches. The brain/head images will be provided to the programmer to permit development of the virtual neuro-navigation algorithm. Data from Yr1 will be used by the programmer as a training sample, and from Yr2 as a test sample. The Go/No-go criterion is an interclass correlation coefficient (ICC) of >.9 between scalp coordinates determined by on-line neuro-navigation and those determined virtually ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05598931
Study type Observational
Source Soterix Medical
Contact Rashel Mejia, BS
Phone 18889908327
Email rmejia@soterixmedical.com
Status Recruiting
Phase
Start date July 1, 2021
Completion date October 1, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04124341 - PCS in Severe Treatment Resistant Depression N/A
Recruiting NCT03887715 - A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression N/A
Completed NCT04727229 - Stellate Ganglion Block for Major Depressive Disorder. Phase 4
Completed NCT04634669 - Open-Label Safety Study of AXS-05 in Subjects With TRD (EVOLVE) Phase 2
Withdrawn NCT03175887 - Investigational TMS Treatment for Depression N/A
Completed NCT03134066 - Neurocognitive Features of Patients With Treatment-Resistant Depression
Active, not recruiting NCT01984710 - Deep Brain Stimulation for Treatment Resistant Depression With the Medtronic Activa PC+S N/A
Completed NCT01935115 - Comparing Ketamine and Propofol Anesthesia for Electroconvulsive Therapy Phase 4
Terminated NCT01687478 - A Study of Olanzapine and Fluoxetine for Treatment-resistant Depression Phase 3
Completed NCT00531726 - Berlin Deep Brain Stimulation Depression Study N/A
Recruiting NCT04041479 - Biomarker-guided rTMS for Treatment Resistant Depression Phase 3
Recruiting NCT05870540 - BPL-003 Efficacy and Safety in Treatment Resistant Depression Phase 2
Recruiting NCT04959253 - Psilocybin in Depression Resistant to Standard Treatments Phase 2
Completed NCT04856124 - Intranasal Esketamine to Maintain the Antidepressant Response to IV Racemic Ketamine
Recruiting NCT03272698 - ECT With Ketamine Anesthesia vs High Intensity Ketamine With ECT Rescue for Treatment-Resistant Depression Phase 4
Active, not recruiting NCT04451135 - CET- REM (Correlating ECT Response to EEG Markers) N/A
Recruiting NCT05680220 - 40 Hz Light Neurostimulation for Patients With Depression (FELIX) N/A
Completed NCT03288675 - Stepped Care aiTBS 2 Depression Study (Ghent) N/A
Recruiting NCT06138691 - KET-RO Plus RO DBT for Treatment Resistant Depression Phase 1
Terminated NCT02675556 - Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in Patients With Treatment Resistant Depression Phase 1