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

Treatment Resistant Depression Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03986658
• Other study ID #: CHEO19P1
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: NeuroQore Inc.
• Contact: Kathleen Pajer, MD
• Phone: 613-737-7600
• Email: kpajer[@]cheo.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 19
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Device:
• Linear Asymmetric rTMS System
Linear Asymmetric rTMS System

Locations

Country	Name	City	State
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
NeuroQore Inc.	Children's Hospital of Eastern Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Enrollment Rate	Number of patients who give consent divided by the number who are approached.	Through study completion, an average of 10 months
Primary	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
Primary	Side Effects Profile	Measured with the rTMS Side Effect Questionnaire	Through study completion, an average of 10 months
Primary	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	Change in self-reported MDD symptoms	Measured with the Child Depression Inventory-2.(CDI-2)	Change from baseline score to score at 3 months
Secondary	Change in clinician-rated MDD symptoms	Measured with the Child Depression Rating Scale-Revised (CDRS-R)	Change from baseline score to score at 3 months
Secondary	Change in function	Measured with the Children's Global Assessment Scale (C-GAS)	Change from baseline score to score at 3 months
Secondary	Change in mental status	Measured with the Mini-Mental State Examination (MMSE)	Change from baseline score to score at 3 months
Secondary	Change in short-term verbal memory	Measured with the Hopkins Verbal Learning Test-Revised (HLVT-R)	Change from baseline score to score at 3 months