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Coil Positioning in Navigated Transcranial Magnetic Stimulation Feasibility in Depression Patients Trial

NCT03795051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-01-03

No results posted yet for this study

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.

Conditions

  • Depressive Disorder, Major

Interventions

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.

Sponsors & Collaborators

  • Magstim

    lead INDUSTRY

Principal Investigators

  • Lothar Krinke, PhD · Magstim

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-09
Primary Completion
2019-09-01
Completion
2019-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03795051 on ClinicalTrials.gov