iTBS in Refractory Pediatric Depression

Trial ID or NCT#

NCT03845504

Status

not recruiting iconNOT RECRUITING

Purpose

This work will mark the first step in understanding the neural targets for rTMS in youth with difficult to treat depressive symptoms, creating benchmarks for optimizing the safety and efficacy of rTMS for pediatric populations through precision targeting, and encourage funding applications for larger sham- controlled randomized clinical studies.

Official Title

Evaluating the Efficacy and Tolerability of Targeted Transcranial Magnetic Stimulation in Youth

Eligibility Criteria

Ages Eligible for Study: 12 Years to 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 10 participants ages 12-21 years of age* with at least moderate to severe depressive symptoms confirmed by the Children's Depression Rating Scale-Revised (CDRS-R\>40) or Hamilton Rating Scale for Depression (HRSD-17 ≥ 18)* able to commit to protocol schedule and provide Informed consent by a legal guardian and assent by a youth participant* have had at least one prior antidepressant treatment failure with adequate dose and duration
Exclusion Criteria:
  1. * prior neurological diagnosis (neurodevelopmental disorders, strokes/traumatic brain injuries, brain tumor, epilepsy)* contraindications for TMS or MRI e.g. have any implanted metal* unstable medical conditions* acute suicide risk, defined as an attempt in past 6 months that required medical treatment, or history of ≥2 suicide attempts in the past 12 months, or has a clear cut plan for suicide* pregnancy, suspected pregnancy or not on birth control if sexually active; 6) Inability to locate and quantify a motor threshold* any factor that the PI determines to be reason for exclusion.
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Investigator(s)

Nolan Williams
Nolan Williams
Deep brain stimulation specialist, Neuroimaging specialist, Psychiatrist
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator) and, by courtesy, of Radiology (Neuroimaging and Neurointervention)

Contact us to find out if this trial is right for you.

Contact

Romina Nejad, BS
650-497-3933

View on ClinicalTrials.gov