iTBS in Refractory Pediatric Depression
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|ClinicalTrials.gov Identifier: NCT03845504|
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Device: Intermittent Theta Burst Stimulation||Not Applicable|
Problem Statement: Depression is a global health problem with limited novel and targeted solutions. Currently available interventions (medication and psychotherapy) have failed to provide adequate clinical improvement in 40% of adolescents with depression and only produce remission in 30% of youth. There is a clear need to develop better targeted interventions for this growing population of youth.
Specific Aims Aim 1: To examine the efficacy of a targeting strategy to optimize repetitive transcranial magnetic stimulation (rTMS) delivered to the left dorsolateral prefrontal cortex (DLPFC) to reduce depressive symptoms in adolescents between 12-17 years of age. Hypothesis 1: Six weeks of open-label daily intermittent theta-burst stimulation (iTBS) sessions delivered to the left DLPFC will be effective at reducing depressive symptoms between baseline and 10- week follow-up. Hypothesis 2: iTBS over left DLPFC will decrease functional connectivity between left DLPFC and subcallosal cingulate cortex (SCC) and will reduce depression-related hyperconnectivity between nodes of the default mode network (DMN). Hypothesis 3: Higher anti-correlation between left DLPFC and SCC and lower cingulate glutamate concentrations will predict better clinical outcome following iTBS.
Aim 2: To determine the tolerability of iTBS in adolescents between 12-17 years of age. Hypothesis 1: iTBS will be well tolerated without any more than minimal side effects. Hypothesis 2: iTBS will result in sufficient cortical excitability, as measured by 64-channel-EEG pre, during, and post iTBS, to induce an antidepressant effect but not induce seizures or other adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating the Efficacy and Tolerability of Targeted Transcranial Magnetic Stimulation in Youth|
|Estimated Study Start Date :||April 23, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 20, 2022|
Experimental: Open Label
Open-label rTMS sessions will occur within ~2 days after the baseline session with daily sessions delivered to left DLPFC over 2-6 weeks. Stimulation will be administered using the MagVenture MagPro rTMS Research System at currently FDA approved parameters (www.magvitatms.com). The TBS parameters will be 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 80% active motor threshold, as measured from the right first dorsal interosseous muscle by a hand-held 700-mm figure-of-eight coil. rTMS will be applied for 9 min delivering a total of 1800 pulses/session.
Device: Intermittent Theta Burst Stimulation
Daily open-label sessions delivered to left DLPFC over up to 6 weeks using the MagVenture MagPro rTMS Research System at currently FDA approved parameters (www.magvitatms.com). The TBS parameters will be 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 80% active motor threshold, as measured from the right first dorsal interosseous muscle by a hand-held 700-mm figure-of-eight coil. rTMS will be applied for 9 min delivering a total of 1800 pulses/session.
- Change in Children's depression rating scale - revised (CDRS-R) score from baseline to 6 weeks. [ Time Frame: Baseline to up to 6 weeks ]Standardized assessment to determine depression severity. Total score ranges from 17-113. In general, higher values of CDRS-R total score represent greater severity of illness. Response to treatment is determined by a ≥ 50% reduction in score from baseline to end of treatment.
- Change in Hamilton Rating Scale for Depression (HRSD-17) from baseline to 6 weeks [ Time Frame: Baseline to up to 6 weeks ]Standardized assessment to determine depression severity. Total score ranges from 0-52, with higher scores representing greater severity of illness. Response to treatment is determined by a ≥ 50% reduction in score from baseline to end of treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03845504
|Contact: Manpreet K Singh, MD MSfirstname.lastname@example.org|
|Contact: Nolan Williams, MDemail@example.com|
|United States, California|
|Stanford University Pediatric Mood Disorders Program||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Sarthak Angal, BS 650-721-4049 firstname.lastname@example.org|
|Contact: Esther Rah, BA 6507255922 email@example.com|
|Principal Investigator:||Manpreet K Singh, MD MS||Associate Professor|
|Principal Investigator:||Nolan Williams, MD||Clinical Assistant Professor|
|Principal Investigator:||Hugh B Solvason, PhD MD||Associate Professor|
|Principal Investigator:||Keith Sudheimer, PhD||Instructor|