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Recruiting
NCT05598931
Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI
Conditions: Treatment Resistant Depression
Sex: All
Ages: 18 Years – 60 Years
Enrollment: 10
Sponsor: Soterix Medical
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Non-depressed subjectsExclusion Criteria:Ever met criteria for a psychotic disorder (Sz, SzAff, Bipolar disorder); anorexia nervosa or bulimia nervosa within the last yearUnstable medical condition by history, physical exam or laboratory resultsContraindications to MRI (based on metal screening form)Meets criteria for claustrophobiaRecent 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 useA neurological or neuromuscular disorder;Require medications for a general medical condition that contraindicate the TMS treatmentHistory of ketamine treatment within 6 moHistory of monoamine oxidase inhibitor (MAOI) within the past monthLacks capacity to consentTaking 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
Source: ClinicalTrials.gov (NCT05598931). StuddyBuddy aggregates publicly available trial information.