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

Primary Purpose

Treatment Resistant Depression

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Linear Asymmetric rTMS System
Sponsored by
NeuroQore Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Treatment Resistant Depression focused on measuring Major Depressive Disorder, Repetitive Transcranial Magnetic Stimulation (rTMS), Treatment-Resistant Depression, Adolescents

Eligibility Criteria

15 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion:

  1. Meets criteria for DSM-5 MDD, as determined by a structured psychiatric interview.
  2. Meets criteria for TRD:

    1. failed two adequate courses of antidepressant medication OR
    2. failed adequate course of medication AND one course of psychotherapy.
  3. Score of > 40 on Child Depression Rating Scale-Revised OR score of > 20 on Child Depression Inventory-2.
  4. Fluent in speaking and reading English.

Exclusion:

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

Sites / Locations

  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adolescents

Arm Description

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.

Outcomes

Primary Outcome Measures

Patient Enrollment Rate
Number of patients who give consent divided by the number who are approached.
Patient Completion Rate
Number of patients who complete the study divided by the number of patients who enroll in the study.
Side Effects Profile
Measured with the rTMS Side Effect Questionnaire
Patient Experience
Measured with the Multi-Care Institute for Research and Innovation Research Participant Satisfaction Questionnaire

Secondary Outcome Measures

Change in self-reported MDD symptoms
Measured with the Child Depression Inventory-2.(CDI-2)
Change in clinician-rated MDD symptoms
Measured with the Child Depression Rating Scale-Revised (CDRS-R)
Change in function
Measured with the Children's Global Assessment Scale (C-GAS)
Change in mental status
Measured with the Mini-Mental State Examination (MMSE)
Change in short-term verbal memory
Measured with the Hopkins Verbal Learning Test-Revised (HLVT-R)

Full Information

First Posted
May 31, 2019
Last Updated
August 30, 2021
Sponsor
NeuroQore Inc.
Collaborators
Children's Hospital of Eastern Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT03986658
Brief Title
Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day
Official Title
Dose-Response Study of Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 2022 (Anticipated)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NeuroQore Inc.
Collaborators
Children's Hospital of Eastern Ontario

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The 18 patients will be placed into 6 sub-groups sequentially as they are enrolled. All patients will receive a maximum of 30,000 pulses in their treatment course, as tolerated. The first group will receive daily sessions, similar to standard rTMS treatment. Each of the remaining groups will be set to receive more frequent sessions/day in decreasing numbers of days on a graduated schedule while holding the total number of pulses for each patient's treatment course at 30,000 pulses. in addition, the investigators will recruit one healthy volunteer to test fMRI server data transfer and analysis. This healthy volunteer will not receive rTMS. Primary Objectives The primary objectives of this study are to assess: 1) the feasibility of enrollment (number of patients who enroll divided by the number of patients approached), 2) study retention (number of patients completing the study divided by the number enrolled), and 3) AE/SE profile of the treatment at each protocol level and 4) patient experience in the study across the sample and within the sub-groups. Secondary Objectives The secondary objectives of this study are to: 1) evaluate daily changes in symptoms of depression and mental status; 2) evaluate fMRI changes in the LDLPFC after treatment; 3) evaluate post-treatment and 3-month changes in depression symptoms, global function, mental status, verbal memory.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
Keywords
Major Depressive Disorder, Repetitive Transcranial Magnetic Stimulation (rTMS), Treatment-Resistant Depression, Adolescents

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
rTMS
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adolescents
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Linear Asymmetric rTMS System
Intervention Description
Linear Asymmetric rTMS System
Primary Outcome Measure Information:
Title
Patient Enrollment Rate
Description
Number of patients who give consent divided by the number who are approached.
Time Frame
Through study completion, an average of 10 months
Title
Patient Completion Rate
Description
Number of patients who complete the study divided by the number of patients who enroll in the study.
Time Frame
Through study completion, an average of 10 months
Title
Side Effects Profile
Description
Measured with the rTMS Side Effect Questionnaire
Time Frame
Through study completion, an average of 10 months
Title
Patient Experience
Description
Measured with the Multi-Care Institute for Research and Innovation Research Participant Satisfaction Questionnaire
Time Frame
Through study completion, an average of 10 months
Secondary Outcome Measure Information:
Title
Change in self-reported MDD symptoms
Description
Measured with the Child Depression Inventory-2.(CDI-2)
Time Frame
Change from baseline score to score at 3 months
Title
Change in clinician-rated MDD symptoms
Description
Measured with the Child Depression Rating Scale-Revised (CDRS-R)
Time Frame
Change from baseline score to score at 3 months
Title
Change in function
Description
Measured with the Children's Global Assessment Scale (C-GAS)
Time Frame
Change from baseline score to score at 3 months
Title
Change in mental status
Description
Measured with the Mini-Mental State Examination (MMSE)
Time Frame
Change from baseline score to score at 3 months
Title
Change in short-term verbal memory
Description
Measured with the Hopkins Verbal Learning Test-Revised (HLVT-R)
Time Frame
Change from baseline score to score at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion: 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. Exclusion: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Pajer, MD
Phone
613-737-7600
Ext
2723
Email
kpajer@cheo.on.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Paula Cloutier
Email
pcloutier@cheo.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Pajer, MD
Organizational Affiliation
Children's Hospital of Eastern Ontario (CHEO)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Pajer, MD
Phone
613-737-7600
Ext
2723
Email
kpajer@cheo.on.ca
First Name & Middle Initial & Last Name & Degree
Robert Chen, MD, Toronto Western Hospital, University of Toronto
First Name & Middle Initial & Last Name & Degree
Paula Cloutier, MA
First Name & Middle Initial & Last Name & Degree
Addo Boafo, MD
First Name & Middle Initial & Last Name & Degree
Elka Miller, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
clintrials.gov

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

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