Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day

NCT03986658 | Unknown DMC

• 1 other identifier: CHEO19P1
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot interventional study to investigate the acceptability, tolerability, and side effect profile for varying numbers of treatment sessions/day of a new rTMS treatment in adolescents with treatment-resistant depression (TRD). Conventional rTMS has been limited to sinusoidal biphasic electromagnetic pulses. In contrast, the First Dawn rTMS system by NeuroQore can sustain a repetitive linear asymmetric pulse. In addition, identification of rTMS treatment sites in adolescents with TRD most often relies on anatomic landmarks, but the First Dawn rTMS system utilizes personal fMRI data in a novel algorithm to determine where to apply the rTMS in each patient. Based on adult data in healthy volunteers and patients with TRD, the investigators propose that the First Dawn rTMS system will be acceptable and well-tolerated by adolescents and will have minimal side effects. Please see https://clinicaltrials.gov/ct2/show/NCT02667041 for details on the completed pilot study in adults. The investigators aim to investigate acceptability, tolerability, and side effects in groups of patients receiving treatment in numbers of sessions/day that are gradually accelerated over the course of the study. Results will be used to inform the development of a randomized controlled trial.

Conditions

Treatment Resistant Depression

Keywords

Major Depressive Disorder; Repetitive Transcranial Magnetic Stimulation (rTMS); Treatment-Resistant Depression; Adolescents

Outcome Measures

Primary Outcomes (4)

• Patient Enrollment Rate

  Number of patients who give consent divided by the number who are approached.

  Through study completion, an average of 10 months

• Patient Completion Rate

  Number of patients who complete the study divided by the number of patients who enroll in the study.

  Through study completion, an average of 10 months

• Side Effects Profile

  Measured with the rTMS Side Effect Questionnaire

  Through study completion, an average of 10 months

• Patient Experience

  Measured with the Multi-Care Institute for Research and Innovation Research Participant Satisfaction Questionnaire

  Through study completion, an average of 10 months

Secondary Outcomes (5)

• Change in self-reported MDD symptoms

  Change from baseline score to score at 3 months

• Change in clinician-rated MDD symptoms

  Change from baseline score to score at 3 months

• Change in function

  Change from baseline score to score at 3 months

• Change in mental status

  Change from baseline score to score at 3 months

• Change in short-term verbal memory

  Change from baseline score to score at 3 months

Study Arms (1)

Adolescents

EXPERIMENTAL

Device: First Dawn rTMS System used in 18 patients divided into groups of 3. Each group will receive a different and gradually increasing frequency of treatment sessions/day (1-10) over a decreasing number of days (10-1). The total number of pulses for all levels will be 30,000. The use of each level will be dependent on tolerability and safety of the previous lower level, i.e., if one level is not tolerated well by a group, progression to the next level will not occur.

Device: Linear Asymmetric rTMS System

Interventions

Linear Asymmetric rTMS System DEVICE

Linear Asymmetric rTMS System

Adolescents

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Meets criteria for DSM-5 MDD, as determined by a structured psychiatric interview.
• Meets criteria for TRD:
• failed two adequate courses of antidepressant medication OR
• failed adequate course of medication AND one course of psychotherapy.
• Score of \> 40 on Child Depression Rating Scale-Revised OR score of \> 20 on Child Depression Inventory-2.
• Fluent in speaking and reading English.

You may not qualify if:

• Positive pregnancy test.
• Current or past: bipolar disorder, psychotic disorder, autism spectrum disorder, intellectual disability, substance use disorder, conduct disorder, as determined by a structured psychiatric interview.
• Medical illness that could lower the seizure threshold, e.g., epilepsy from any cause.
• Medications that could lower the seizure threshold or affect brain function.
• Psychotropic medications changed in two weeks prior to enrollment.
• Fails the TMS safety screening questionnaire.
• Fails fMRI screening process.
• Left-handed (may indicate different cortical lateralization which could affect outcomes).
• Involuntarily committed to the hospital.

Sponsors & Collaborators

• NeuroQore Inc.: lead
• Children's Hospital of Eastern Ontario: collaborator

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Kathleen Pajer, MD

  Children's Hospital of Eastern Ontario (CHEO)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Pajer, MD

CONTACT

613-737-7600; kpajer@cheo.on.ca

Paula Cloutier

CONTACT

pcloutier@cheo.on.ca

Study Design

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

Model Details: rTMS

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 14, 2019
• Study Start: March 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 1, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)