Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI

Treatment Resistant Depression Clinical Trial

Official title:

Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05598931
• Other study ID #: SMICU061621B
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: February 2024
• Source: Soterix Medical
• Contact: Rashel Mejia, BS
• Phone: 18889908327
• Email: rmejia[@]soterixmedical.com
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Non-depressed subjects

Exclusion Criteria:

• Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder); anorexia nervosa or bulimia nervosa within the last year

• Unstable medical condition by history, physical exam or laboratory results

• Contraindications to MRI (based on metal screening form)

• Meets criteria for claustrophobia

• Recent drug or alcohol use disorder with DSM-5 specifier of moderate or severe within 6 months, or mild within 2 months; lifetime history of IV drug use

• A neurological or neuromuscular disorder;

• Require medications for a general medical condition that contraindicate the TMS treatment

• History of ketamine treatment within 6 mo

• History of monoamine oxidase inhibitor (MAOI) within the past month

• Lacks capacity to consent

• Taking medications that increase the risk of seizures. For patients on permitted concomitant psychotropic agents (antidepressants, anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, lmethylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry

Related Conditions & MeSH terms

• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Device:
• Transcranial Magnetic Stimulation
Subjects will participate in an on-line neuro-navigation session in which 6 TMS coil positions will be recorded.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Soterix Medical	Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain Coordinates	MRI based brain coordinates will be determined using newly developed neuronavigation software	Day 1