COMPLETED

Virtual Neuro-Navigation System for Personalized Community Based TMS

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Phase I study of a virtual neuro-navigation package with built-in support for identifying specific "surface-based" targets to optimze TMS treatment.

Official Title

Virtual Neuro-Navigation System for Personalized Community Based TMS

Quick Facts

Study Start:2021-07-01

Study Completion:2025-09-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT04956081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules * Met criteria for treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ, as well as an adequate course of TMS treatment using standard targeting approaches (e.g. 5-cm, 5.5-cm, F3) * at least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20	* 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 * Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant * 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 * Actively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention. * A neurological or neuromuscular disorder * Requires medications for a general medical condition that contraindicate the TMS treatment * Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS) * 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, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study

Inclusion Criteria

Exclusion Criteria

* DSM-5 diagnosis of major depressive disorder confirmed using the Mini International Neuropsychiatric Interview (MINI30) Axis 1 and mood modules
* Met criteria for treatment-resistant MDD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ31), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ, as well as an adequate course of TMS treatment using standard targeting approaches (e.g. 5-cm, 5.5-cm, F3)
* at least moderate depression severity, operationalized as Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 20

* 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
* Currently pregnant or breastfeeding women; fecund women not using adequate contraceptive methods or with plan to become pregnant
* 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
* Actively suicidal, as defined by expressive ideation with a plan or with suicidal ideation that requires immediate medical or treatment intervention.
* A neurological or neuromuscular disorder
* Requires medications for a general medical condition that contraindicate the TMS treatment
* Prior non-response to ECT, vagal nerve stimulation (VNS) or deep brain stimulation (DBS)
* 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, l-methylfolate, s-adenosyl methionine, lithium) dosing must be stable for at least four weeks prior to study entry and patients must agree to continue at the same dose during the study

Contacts and Locations

Study Locations (Sites)

Soterix Medical, Inc.

Woodbridge, New Jersey, 07095

United States

Collaborators and Investigators

Sponsor: Soterix Medical

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-01

Study Completion Date2025-09-01

Study Record Updates

Study Start Date2021-07-01

Study Completion Date2025-09-01

Terms related to this study

Additional Relevant MeSH Terms

Treatment Resistant Depression