NCT03795051

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 7, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

January 9, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

January 3, 2020

Status Verified

January 1, 2020

Enrollment Period

8 months

First QC Date

November 14, 2018

Last Update Submit

January 2, 2020

Conditions

Depressive Disorder, Major

Keywords

Transcranial Magnetic StimulationNavigated Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • Percentage of successful nTMS treatment sessions

    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.

    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 (4)

  • Operator Confidence

    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).

  • Patient Comfort

    After last treatment has been completed; approximately six week after treatment start

  • Patient Health Questionnaire 9 (PHQ-9) - Patient Depression Questionnaire

    At baseline and after six weeks of treatment

  • Coil Position deviation from target

    Coil position deviation: every treatment session during week 2 through 6

Study Arms (1)

Navigated TMS

EXPERIMENTAL

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

Interventions

Navigated Transcranial Magnetic StimulationDEVICE

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.

Navigated TMS

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Georgia Behavioral Health Professionals

Atlanta, Georgia, 30342, United States

Location

Georgia Behavioral Health Professionals

Dunwoody, Georgia, 30338, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Lothar Krinke, PhD

    Magstim

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

January 7, 2019

Study Start

January 9, 2019

Primary Completion

September 1, 2019

Study Completion

September 30, 2019

Last Updated

January 3, 2020

Record last verified: 2020-01

Locations

US(2)