Ignite Creation Date:
2024-05-06 @ 12:35 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03795051
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2018-11-14
Brief Title:
Coil Positioning in Navigated Transcranial Magnetic Stimulation Feasibility in Depression Patients Trial
Sponsor:
Magstim
Organization:
Magstim
Study Overview
Official Title:
Precise Coil Positioning in Navigated Transcranial Magnetic Stimulation nTMS in Medication- Resistant Major Depressive Disorder MDD A Feasibility Study
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
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:
CONFIDENT
Brief Summary:
The objective of this study is to evaluate the feasibility of adding a navigational system to traditional repetitive Transcranial Magnetic Stimulation rTMS referred to in this application as nTMS as a way to establish and maintain precise coil positioning contact rotation and tilt and consistent brain region targeting throughout a nTMS treatment session and in subsequent nTMS sessions
Detailed Description:
Objective The objective of this study is to evaluate the feasibility of adding a navigational system to traditional repetitive Transcranial Magnetic Stimulation rTMS referred to in this application as nTMS as a way to establish and maintain precise coil positioning contact rotation and tilt and consistent brain region targeting throughout a nTMS treatment session and in subsequent nTMS sessions Success will be evaluated via data analysis of information captured during nTMS which will evaluate coordinates contact rotation and tilt parameters of the stimulation pulses delivered The study will be conducted with patients who have been selected as traditional rTMS candidates and have met the criteria for rTMS which includes but is not limited to the following Adults with Major Depressive Disorder MDD who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode For the purposes of this study nTMS is referring to the use of a navigation device in combination with delivery of traditional rTMS
Aim 1 Determine the percentage of successful nTMS treatment sessions A successful nTMS treatment session is defined as the following 80 of the TMS pulse trains are delivered while the coil is within acceptance criteria measured by tracking the following parameters coil deviations from digitally saved target location which includes contact mm rotation and tilt parameters The acceptance criteria are met with coil position at the time of pulse delivery as follows coil rotation within 15 of target coil tilt within 15 of target in-plane deviation within 5mm of target contact deviation within 2mm of target
Aim 2 Determine Patient Health Questionnaire PHQ-9 change measured weekly from baseline to after 30 sessions of nTMS collect Patient comfort data measure Operator confidence and collect coil position data for nTMS sessions to determine future product improvements and clinical studies
The goal of this proposal is to establish nTMS as a means of precise administration of transcranial magnetic stimulation Ultimately data from this study will be used to design larger comparative studies to establish superior efficacy profiles in the treatment of MDD
Aim 1 Determine the percentage of successful nTMS treatment sessions A successful nTMS treatment session is defined as the following 80 of the TMS pulse trains are delivered while the coil is within acceptance criteria measured by tracking the following parameters coil deviations from digitally saved target location which includes contact mm rotation and tilt parameters The acceptance criteria are met with coil position at the time of pulse delivery as follows coil rotation within 15 of target coil tilt within 15 of target in-plane deviation within 5mm of target contact deviation within 2mm of target
Aim 2 Determine Patient Health Questionnaire PHQ-9 change measured weekly from baseline to after 30 sessions of nTMS collect Patient comfort data measure Operator confidence and collect coil position data for nTMS sessions to determine future product improvements and clinical studies
The goal of this proposal is to establish nTMS as a means of precise administration of transcranial magnetic stimulation Ultimately data from this study will be used to design larger comparative studies to establish superior efficacy profiles in the treatment of MDD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None