Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression: Tolerability of Treatment Durations Ranging From Ten Days to One Day
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 5
Summary
- Conditions
- Treatment Resistant Depression
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: rTMSMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 15 years and 17 years
- Gender
- Both males and females
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 ...
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.
Tracking Information
- NCT #
- NCT03986658
- Collaborators
- Children's Hospital of Eastern Ontario
- Investigators
- Principal Investigator: Kathleen Pajer, MD Children's Hospital of Eastern Ontario (CHEO)