Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03986658
Status:
UNKNOWN
Last Update Posted:
2021-09-01
First Post:
2019-05-31
Brief Title:
Linear Asymmetric rTMS in Adolescent Treatment-Resistant Depression Tolerability of Treatment Durations Ranging From Ten Days to One Day
Sponsor:
NeuroQore Inc
Organization:
NeuroQore Inc
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2021-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot interventional study to investigate the acceptability tolerability and side effect profile for varying numbers of treatment sessionsday 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 httpsclinicaltrialsgovct2showNCT02667041 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 sessionsday that are gradually accelerated over the course of the study Results will be used to inform the development of a randomized controlled trial
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 httpsclinicaltrialsgovct2showNCT02667041 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 sessionsday 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 30000 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 sessionsday in decreasing numbers of days on a graduated schedule while holding the total number of pulses for each patients treatment course at 30000 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 AESE 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
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 AESE 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None