iTBS in Refractory Pediatric Depression

NCT03845504 | Terminated Results FDA Device

• 1 other identifier: 45848
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

depression; transcranial magnetic stimulation; adolescent; treatment refractory

Outcome Measures

Primary Outcomes (1)

• Change in Children's Depression Rating Scale - Revised (CDRS-R) Score From

  Standardized assessment to determine depression severity. The CDRS-R total score is the sum of the responses to 17 questions. Each question is graded on a 5- or 7-point scale. 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.

  Baseline and week 6

Secondary Outcomes (1)

• Change in Hamilton Depression Rating Scale (HDRS-17)

  Baseline and week 6

Study Arms (1)

Open Label

EXPERIMENTAL

Open-label rTMS sessions will occur within \~2 days after the baseline session with daily sessions delivered to left DLPFC over 2-6 weeks.

Device: Intermittent Theta Burst Stimulation

Interventions

Intermittent Theta Burst Stimulation DEVICE

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.

Open Label

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University Pediatric Mood Disorders Program

Stanford, California, 94305, United States

Location

Related Publications (5)

• Blumberger DM, Vila-Rodriguez F, Thorpe KE, Feffer K, Noda Y, Giacobbe P, Knyahnytska Y, Kennedy SH, Lam RW, Daskalakis ZJ, Downar J. Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. doi: 10.1016/S0140-6736(18)30295-2. Epub 2018 Apr 26.

  PMID: 29726344 BACKGROUND

• Oberman LM, Pascual-Leone A, Rotenberg A. Modulation of corticospinal excitability by transcranial magnetic stimulation in children and adolescents with autism spectrum disorder. Front Hum Neurosci. 2014 Aug 13;8:627. doi: 10.3389/fnhum.2014.00627. eCollection 2014.

  PMID: 25165441 BACKGROUND

• Wall CA, Croarkin PE, Maroney-Smith MJ, Haugen LM, Baruth JM, Frye MA, Sampson SM, Port JD. Magnetic Resonance Imaging-Guided, Open-Label, High-Frequency Repetitive Transcranial Magnetic Stimulation for Adolescents with Major Depressive Disorder. J Child Adolesc Psychopharmacol. 2016 Sep;26(7):582-9. doi: 10.1089/cap.2015.0217. Epub 2016 Feb 5.

  PMID: 26849202 BACKGROUND

• Weigand A, Horn A, Caballero R, Cooke D, Stern AP, Taylor SF, Press D, Pascual-Leone A, Fox MD. Prospective Validation That Subgenual Connectivity Predicts Antidepressant Efficacy of Transcranial Magnetic Stimulation Sites. Biol Psychiatry. 2018 Jul 1;84(1):28-37. doi: 10.1016/j.biopsych.2017.10.028. Epub 2017 Nov 10.

  PMID: 29274805 BACKGROUND

• Li CT, Chen MH, Juan CH, Liu RS, Lin WC, Bai YM, Su TP. Effects of prefrontal theta-burst stimulation on brain function in treatment-resistant depression: A randomized sham-controlled neuroimaging study. Brain Stimul. 2018 Sep-Oct;11(5):1054-1062. doi: 10.1016/j.brs.2018.04.014. Epub 2018 Apr 23.

  PMID: 29730251 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

Early termination led to a small number of subjects analyzed.

Results Point of Contact

• Title: Director, Research Development, Integrity and Strategy
• Organization: Stanford University

aimnoe@stanford.edu

(650) 736-4559

Study Officials

• Manpreet K Singh, MD MS

  Associate Professor

  PRINCIPAL INVESTIGATOR

• Nolan Williams, MD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

• Hugh B Solvason, PhD MD

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: February 19, 2019
• Study Start: November 19, 2018
• Primary Completion: October 9, 2019
• Study Completion: October 9, 2019
• Last Updated: December 12, 2023
• Results First Posted: December 12, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)