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Coil Positioning in Navigated Transcranial Magnetic Stimulation Feasibility in Depression Patients Trial (CONFIDENT)

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ClinicalTrials.gov Identifier: NCT03795051
Recruitment Status : Enrolling by invitation
First Posted : January 7, 2019
Last Update Posted : March 11, 2019
Sponsor:
Information provided by (Responsible Party):
Magstim

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Device: Navigated Transcranial Magnetic Stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precise Coil Positioning in Navigated Transcranial Magnetic Stimulation (nTMS) in Medication- Resistant Major Depressive Disorder (MDD): A Feasibility Study
Actual Study Start Date : January 9, 2019
Estimated Primary Completion Date : June 10, 2019
Estimated Study Completion Date : June 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Navigated TMS
Each participant will receive 30 sessions of 10 Hz or 20 Hz navigated transcranial magnetic stimulation over the left DLPFC.
Device: Navigated Transcranial Magnetic Stimulation
This study is a feasibility trial. Each participant will receive 30sessions of 10 Hz or 20 Hz rTMS over the left DLPFC. The rTMS interventions will be guided by a neuronavigation system (StimGuide TMS Navigation System, Magstim, Ltd. Carmarthenshire, UK) for navigation to the treatment location and to ensure consistent placement and orientation of the coil during and between each session. For the purpose of this protocol, these sessions are referred to as nTMS.




Primary Outcome Measures :
  1. Percentage of successful nTMS treatment sessions [ Time Frame: 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.) ]
    The primary outcome measure will be the percentage of successful nTMS treatment sessions pooled from sessions 6 through 30 for each study subject. A successful nTMS treatment session is defined as: 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.


Secondary Outcome Measures :
  1. Operator Confidence [ Time Frame: 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). ]
    Operator confidence will be measured on a scale of 1 to 5; 1 being not confident at all in using StimGuide to consistently find the treatment site and deliver therapy to 5 being very confident in using StimGuide to consistently find the treatment site and deliver therapy.

  2. Patient Comfort [ Time Frame: After last treatment has been completed; approximately six week after treatment start ]
    Patient comfort measured on a scale from 1 to 5; with 1 being uncomfortable and 5 being extremely comfortable

  3. Patient Health Questionnaire 9 (PHQ-9) - Patient Depression Questionnaire [ Time Frame: At baseline and after six weeks of treatment ]
    Patient Health Questionnaire (PHQ-9) change from baseline. The PHQ-9 Patient Depression Questionnaire has 9 questions with a scale range for each question of 0 to 3 (0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day. The maximum summed score (severely depressed) is 27.

  4. Coil Position deviation from target [ Time Frame: Coil position deviation: every treatment session during week 2 through 6 ]
    Coil deviation for every pulse train for each patient's nTMS session. Coil deviations from digitally saved target location, which includes contact (mm), rotation (°), and tilt (°) parameters will be measured and reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795051


Locations
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United States, Georgia
Georgia Behavioral Health Professionals
Atlanta, Georgia, United States, 30342
Georgia Behavioral Health Professionals
Dunwoody, Georgia, United States, 30338
Sponsors and Collaborators
Magstim
Investigators
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Principal Investigator: Lothar Krinke, PhD Magstim
  Study Documents (Full-Text)

Documents provided by Magstim:
Study Protocol and Informed Consent Form  [PDF] November 26, 2018


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Responsible Party: Magstim
ClinicalTrials.gov Identifier: NCT03795051     History of Changes
Other Study ID Numbers: MGS-2018-SS
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Magstim:
Transcranial Magnetic Stimulation
Navigated Transcranial Magnetic Stimulation
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms