Clinical trial NCT03795051: Coil Positioning in Navigated Transcranial Magnetic Stimulation Feasibility in Depression Patients Trial
Official title: Precise Coil Positioning in Navigated Transcranial Magnetic Stimulation (nTMS) in Medication- Resistant Major Depressive Disorder (MDD): A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder, Major
Keywords: Transcranial Magnetic Stimulation
Navigated Transcranial Magnetic Stimulation
Lead sponsor: Magstim
Sponsor class: INDUSTRY
First posted: 2019-01-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of medication-resistant MDD,
* Age 18 years or older
* Normal findings in the medical history, physical, and neurological examination

Exclusion Criteria:

* History of seizure disorder
* History of neuroleptic medications/prior use of neuroleptics
* Presence of implanted medical pump, metal plate, or metal object in skull or eye
* Pregnant women

Primary outcomes:
measure: Percentage of successful nTMS treatment sessions
timeFrame: The number of successful treatment sessions will be assessed after 6 weeks of treatment. Only data from week 2 through 6 will be included (approximately 25 treatment sessions). (Example 20 out of 25 sessions were successful.)
Secondary outcomes:
measure: Operator Confidence
timeFrame: Aproximately 5 months after first patient treatment. After last study patient at site has completed the treatment or has exited the study (expected for May 2019).
measure: Patient Comfort
timeFrame: After last treatment has been completed; approximately six week after treatment start
measure: Patient Health Questionnaire 9 (PHQ-9) - Patient Depression Questionnaire
timeFrame: At baseline and after six weeks of treatment
measure: Coil Position deviation from target
timeFrame: Coil position deviation: every treatment session during week 2 through 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Behavioral Health Professionals
state: Georgia
city: Dunwoody
country: United States
facility: Georgia Behavioral Health Professionals
state: Georgia
Study officials:
affiliation: Magstim
name: Lothar Krinke, PhD
role: PRINCIPAL_INVESTIGATOR
References: