NeuroStar TMS Therapy System: Utilization and Outcomes

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01114477

Enrollment

307

Registered

2010-05-03

Start date

2010-03-31

Completion date

2012-09-30

Last updated

2015-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Transcranial magnetic stimulation, TMS, Observational study, Major Depression

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Major Depressive Disorder

Exclusion criteria

* Contraindications to treatment with TMS

Design outcomes

Primary

Measure	Time frame	Description
Total Score on the Patient Health Questionnaire 9-Item (PHQ-9)	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.

Secondary

Measure	Time frame	Description
Total score for the Clinical Global Impressions-Severity (CGI-S)	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.
Total score for the Inventory of Depressive Symptoms-Self Report (IDS-SR)	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.
Total Score for the EuroQol Questionnaire (EQ-5D)	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.
Health Resource Utilization Questionnaire (HRU)	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.
Short Form 36-Item Questionnaire(SF-36) Individual Factor Scores and General Medical and Mental Health Composite Scores	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.

Countries

United States

Outcome results