Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

iTBS in Refractory Pediatric Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03845504
Recruitment Status : Recruiting
First Posted : February 19, 2019
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Manpreet Kaur Singh, Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Device: Intermittent Theta Burst Stimulation Not Applicable

Detailed Description:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 10 participants ages 12-17 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:

  • 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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Manpreet K Singh, MD MS 6507255922 mksingh@stanford.edu
Contact: Nolan Williams, MD 8434607741 nolanw@stanford.edu

Locations
Layout table for location information
United States, California
Stanford University Pediatric Mood Disorders Program Recruiting
Stanford, California, United States, 94305
Contact: Sarthak Angal, BS    650-721-4049    sangal@stanford.edu   
Contact: Esther Rah, BA    6507255922    esthersr@stanford.edu   
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
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

Publications:

Layout table for additonal information
Responsible Party: Manpreet Kaur Singh, Associate Professor of Psychiatry and Behavioral Sciences - Child and Adolescent Psychiatry and Child Development, Stanford University
ClinicalTrials.gov Identifier: NCT03845504     History of Changes
Other Study ID Numbers: 45848
First Posted: February 19, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Small pilot study that will be the start of setting up a larger treatment trial that will be publically available. If feasible, results of the pilot study will be published in scientific journals.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Manpreet Kaur Singh, Stanford University:
depression
transcranial magnetic stimulation
adolescent
treatment refractory

Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders