NeuroStar TMS Therapy System: Utilization and Outcomes

November 11, 2015 updated by: Neuronetics

NeuroStar TMS Therapy System: Data Management, Analysis and Reporting Format for Clinical Treatment Utilization and Outcomes (Protocol no. 19-50001-000,Rev D

The major objective of this observational study is to describe clinical outcomes of patients receiving treatment with the NeuroStar TMS Therapy system in routine clinical practice.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
307

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Lee Ann Kelley, M.D., PC
    • California
      • Berkeley, California, United States, 94704
        • Bay Psychiatric Associates
      • Beverly Hills, California, United States, 90210
        • TMS Center of Beverly Hills
      • Burlingame, California, United States, 94010
        • Clinical Training & Research Institute
      • El Dorado Hills, California, United States, 95762
        • Sacramento TMS
      • Hermosa Beach, California, United States, 90254
        • Martha Koo, MD
      • Laguna Hills, California, United States, 92653
        • Orange County TMS Center
      • Los Angeles, California, United States, 90024
        • Depression Research Center and Clinic-Semel Institute for Neuroscience & Human Behavior at UCLA
      • Mission Viejo, California, United States, 92691
        • Kevin Kinback, MD
      • Pasadena, California, United States, 91101
        • Todd Hutton, MD & Associates
      • San Diego, California, United States, 92130
        • The Botkiss Center for TMS Therapy
      • Stanford, California, United States, 94305
        • Stanford Hospital and Clinics
      • Woodland Hills, California, United States, 91364
        • Arjun Reyes, MD
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care
    • Delaware
      • Wilmington, Delaware, United States, 19801
        • Christiana Care Health Services
    • Florida
      • Boca Raton, Florida, United States, 33432
        • Health Sciences America, Llc
      • Lakeland, Florida, United States, 33803
        • Curtis Cassidy, MD
    • Georgia
      • Atlanta, Georgia, United States, 30305
        • Brian Teliho, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Medical Faculty Foundation
      • Chicago, Illinois, United States, 60601
        • Carl M. Wahlstrom, Jr. MD Limited
      • Northbrook, Illinois, United States, 60062
        • Brain Stimulation Chicago North Shore
      • Schaumburg, Illinois, United States, 60194
        • Behavioral Health Care Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40222
        • Integrative Psychiatry
      • Louisville, Kentucky, United States, 40202
        • University Psychiatric Foundation
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Spectrum Behavioral Health
      • Baltimore, Maryland, United States, 21285
        • Sheppard Pratt Health System
      • St. Michaels, Maryland, United States, 21663
        • Anthony Drobnick, MD
    • Massachusetts
      • Newton, Massachusetts, United States, 02462
        • Newton-Wellesley Psychiatry
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Central Psychiatry
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • TMS Center of New England
    • New Mexico
      • Santa Fe, New Mexico, United States, 87501
        • Santa Fe TMS Therapy Center
    • New York
      • Amherst, New York, United States, 14226
        • Dent Neurosciences Research Center, Inc.
    • Pennsylvania
      • West Chester, Pennsylvania, United States, 19382
        • The TMS Institute of Pennsylvania-Advanced Neuropsychiatric Solutions
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Butler Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • W. Scott West, M.D.
    • Texas
      • Amarillo, Texas, United States, 79106
        • Texas Neuropsychiatric Institute
      • Austin, Texas, United States, 78757
        • Texas TMS Center at Senior Adults Specialty Healthcare (SASH)
      • Houston, Texas, United States, 77024
        • Houston TMS
      • Lewisville, Texas, United States, 75077
        • Agape Mind Services/The Costello Clinic
      • Sugar Land, Texas, United States, 77479
        • Serenity Center for Depression, P.A.
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • University Neuropsychiatric Institute
    • Washington
      • Mercer Island, Washington, United States, 98040
        • Center For Anxiety and Depression

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical practice locations providing clinical treatment with the NeuroStar TMS Therapy System.

Description

Inclusion Criteria:

  • Major Depressive Disorder

Exclusion Criteria:

  • Contraindications to treatment with TMS

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)
Time Frame: Baseline and 6 weeks
The primary outcome measure will reported as the change from baseline through 6 weeks for the total score on the PHQ-9.
Baseline and 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total score for the Clinical Global Impressions-Severity (CGI-S)
Time Frame: Baseline, 6 weeks and 12 Months
The change from baseline to endpoint on the total score for the CGI-S will be reported for the 6 week and 12 month time points.
Baseline, 6 weeks and 12 Months
Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)
Time Frame: Baseline, 6 weeks and 12 Months
The change from baseline to endpoint on the total score for the IDS-SR will be reported for the 6 week and 12 month time points.
Baseline, 6 weeks and 12 Months
Total Score for the EuroQol Questionnaire (EQ-5D)
Time Frame: Baseline, 6 weeks, and 12 Months.
The change from baseline to endpoint on the total score for the EQ-5D will be reported for the 6 week and 12 month time points.
Baseline, 6 weeks, and 12 Months.
Health Resource Utilization Questionnaire (HRU)
Time Frame: Baseline, 6 weeks, and 12 Months
The change from baseline in health care service utilization reported on the individual questions contained in the HRU will be reported for the 6 week and 12 month time points.
Baseline, 6 weeks, and 12 Months
Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores
Time Frame: Baseline, 6 weeks, and 12 Months.
The change from baseline to endpoint on the Individual Factor Scores and General Medical and Mental Health Composite Scores for the SF-36 will be reported for the 6 week and 12 month time points.
Baseline, 6 weeks, and 12 Months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neuronetics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mark Demitrack, MD, Neuronetics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-50001-000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings