Depressive Disorder, Major Clinical Trial
Official title:
Precise Coil Positioning in Navigated Transcranial Magnetic Stimulation (nTMS) in Medication- Resistant Major Depressive Disorder (MDD): A Feasibility Study
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.
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.
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