Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Treatment Resistant Depression
- Sponsor
- Soterix Medical
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Brain Coordinates
- Status
- Completed
- Last Updated
- 7 months ago
Overview
Brief 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.
Detailed 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
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Brain Coordinates
Time Frame: Day 1
MRI based brain coordinates will be determined using newly developed neuronavigation software