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Clinical Studies
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A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents with Suicidal Ideation Associated with Major Depressive Disorder (ATBSSI)
Rochester, Minn.
The proposed study will examine sequential bilateral accelerated theta burst stimulation (aTBS). Three sessions are administered daily for 10 days (5 days per week). During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The theta burst stimulation (TBS) parameters were adopted from prior work, with 3-pulse 50 Hz bursts given every 200 ms (at 5 Hz) with an intensity of 80% of active motor threshold. The comparison group will receive 3 daily sessions of bilateral sham TBS treatment for 10 days. Subjects in both groups will take part in a daily psychotherapeutic treatment program.
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tRNS Treatment for ADHD Symptoms
Rochester, Minn.
The purpose of this study is to examine the safety and effectiveness of tRNS on unmedicated pediatric patients (7-12 years) with ADHD.
Closed for Enrollment
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A Pharmacokinetic/Pharmacodynamic Genetic Variation Treatment Algorithm Versus Treatment As Usual for Adolescent Management Of Depression (Abbreviation Assurex AMOD) (AMOD)
Rochester, Minn.,
Austin, Minn.
The overall goal of this investigator-initiated trial is to evaluate the impact of platform algorithm products designed to rapidly identify pharmacokinetic (PK) and/or pharmacodynamic (PD) genomic variation on treatment outcome of depression in adolescents. This new technology may have the potential to optimize treatment selection by improving response, minimizing unfavorable adverse events / side effects and increasing treatment adherence
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A Pilot Study of the Tolerability and Efficacy of Transcranial Direct Current Stimulation (tDCS) in Children and Adolescents With Epilepsy and Comorbid Depression
Rochester, Minn.
The proposed study seeks to obtain preliminary signal of the tolerability and efficacy of transcranial direct current stimulation (tDCS) for depressive symptoms in a sample of adolescents with depression and epilepsy. Additionally, effects of tDCS will be assessed via electroencephalographic, cognitive, and psychosocial measures.
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A Prospective, Multicenter, Double-Blind, Sham-Controlled Adaptive Design Study to Confirm the Safety and Efficacy of NEST sTMS in Subjects With Major Depressive Disorder Who Have Not Responded to at Least One Antidepressant Medication in the Current Episode
Rochester, Minn.
This is a double-blind, sham controlled, multi-center study to confirm the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) for the treatment of patients currently experiencing an episode of depression who have failed to respond to at least one (1) antidepressant medication. Patients will be randomly assigned to either active or sham therapy and will undergo daily treatments for a period of time. Following completion of blinded treatments, patients may be eligible for a course of open label treatments.
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A Randomized, Double-Blinded, Sham-Controlled Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents
Rochester, Minn.
This research proposal aims to better understand the neurobiology of depression in adolescents and how repetitive transcranial magnetic stimulation (rTMS) may therapeutically impact brain function and mood. This investigation also proposes the first study to examine the efficacy of rTMS maintenance therapy in adolescents who have met clinical criteria following acute rTMS treatment. The magnetic resonance (MR) spectroscopy pattern of rTMS response will be analyzed according to previously established protocols.
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A Randomized, Sham-Controlled Trial Evaluating the Safety and Effectiveness of NeuroStar® Transcranial Magnetic Stimulation (TMS) Therapy in Depressed Adolescents
Rochester, Minn.
To evaluate the safety and efficacy of daily, active Neurostar® TMS (when compared with sham treatment) in adolescents meeting criteria for Major Depressive Disorder (MDD).
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An Open-Label Eight-Week Trial of Repetitive Transcranial Magnetic Stimulation in Depressed Adolescents: Mechanisms of Response
Rochester, Minn.
This research study aims to test the safety and effectiveness of repetitive transcranial magnetic stimulation (rTMS) on teens with depression. The study also seeks to understand how rTMS treatment affects the neurobiology of teens with depression.
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Clinical Pilot of Augmented Human Intelligence in Major Depressive Disorder (AHI/Depression Pilot)
Rochester, Minn.,
Jacksonville, Fla.
The primary purpose of this study is to evaluate the degree of statistical agreement between observed clinical outcomes (non-response/remission) after 8 weeks of treatment and the outcomes predicted by an Augmented Human Intelligence (AHI)-based clinical decision support tool after 2 weeks of follow up.
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Cortical Excitability and Inhibition in Children and Adolescents with Major Depressive Disorder
Rochester, Minn.
The purpose of this study is to learn if measures of brain activity are different in children and adolescents with depression who are in different stages of treatment. This is important because it may identify a biological marker for depression that could one day be used to identify depressed children who would benefit from certain treatments (medications for example), or to monitor how well treatments are working. Brain activity measures(known as cortical excitability and inhibition) will be collected by Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive (no surgery or implants) brain stimulation technology which can make parts of the brain work without putting any wires or chemicals into the body. Measurements will take place over one 3-hour visit. This study does not provide any form of treatment.
*There is an optional portion of the study that uses a brain scan to gather measures of brain structure and brain chemicals. The brain scan is called magnetic resonance and spectroscopy (MRI/MRS). MRI/MRS uses magnetic fields to study the structure of the brain and brain chemicals. The PI will determine eligibility for the MRI/MRS portion of the study.
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Depression, Anxiety, and Traumatic Stress in People with Myocarditis and Their Identified Supports: A Comprehensive Survey-Based Study
Rochester, Minn.,
Jacksonville, Fla.
The purpose of this study is to validate measures of depression, anxiety, traumatic stress, and factors related to these outcomes in medical patients, to develop a model for identifying persons with myocarditis who are at risk for depressive and anxiety disorders (clinically significant depressive and anxious symptoms), and for examining the effects of anxiety and depression on quality of life and health outcomes in respondents with myocarditis and caregivers.
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Effects of Social Media Use on Self-esteem, Depressive Symptoms, Psychiatric Morbidity, and Physiological Markers of Stress in Adolescent Psychiatric Patients and Healthy Controls
Rochester, Minn.
The purpose of this study is to contribute to our understanding of the relationships between social media use in adolescents and psychological development, psychiatric comorbidity, and physiological markers of stress.
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Glutamate Probes in Adolescent Depression (GPII)
Rochester, Minn.
The purpose of this study is to learn if measures of brain chemicals from a brain scan called Magnetic Resonance Imaging and Spectroscopy (MRI/MRS) and brain activity (known as cortical excitability and inhibition) collected by Transcranial Magnetic Stimulation (TMS) are different in adolescents with depression who are in different stages of treatment. Researchers are conducting this study to learn more about how the brain works in adolescents with depression and without depression (healthy controls). This is important because it may identify a biological marker (a measure of how bad an illness is) for depression that could one day be used to identify depressed adolescents who would benefit from certain treatments (medications for example) or to monitor how well treatments are working.
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Glutamatergic and GABAergic Biomarkers in Repetitive Transcranial Magnetic Stimulation (rTMS) for Adolescent Depression PHASE I: University of Minnesota Center for Magnetic Resonance Research and Mayo Clinic 7T Magnetic Resonance Imaging (MRI) and Magnetic Resonance Spectroscopy (MRS) Study
Rochester, Minn.
The purpose of this study is to study brain chemistry in depressed patients compared to healthy patients who are not depressed.
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Glutamatergic and GABAergic Biomarkers in rTMS for Adolescent Depression
Rochester, Minn.
The purpose of this study is to gather information regarding the use of rTMS as a treatment for depression in adolescents with Major Depressive Disorder. The investigators also hope to learn if measures of brain activity (cortical excitability and inhibition) collected with transcranial magnetic stimulation (TMS) can be used to identify which patients will benefit from certain types of rTMS treatment.
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PISTACHIO (PREEMPTIION OF DISRUPTIVE BEHAVIOR IN CHILDREN) REAL-TIME MONITORING OF SLEEP AND BEHAVIOR OF CHILDREN 3-7-YEAR-OLD RECEIVING PARENT CHILD INTERACTION THERAPY AUGMENTED WITH ARTIFICIAL INTELLIGENCE RANDOMIZED CONTROLLED TRIAL. (PISTACHIO)
Rochester, Minn.
The purpose of this study is to develop an innovative wearable tracking protocol that will use AI technology to monitor sleep and behavior of 3-7 year old children.
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Quantitative EEG Correlates of Suicidal Behaviors in Children and Adolescents
Rochester, Minn.
The purpose of this study is to examine qEEG correlates of suicidal ideations and behaviors (SIBS) (screened by the Columbia-Suicide Severity Rating Scale (C-SSRS)) in hospitalized adolescents between the ages of 13-18 years as compared to age-matched healthy participants.
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Sprites: Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
Rochester, Minn.
The purpose of this study is to evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and maturation at puberty, in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.
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