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Imaging Biomarkers for TMS Treatment of Depression

Primary Purpose

Depression

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

repetitive Transcranial Magnetic Stimulation (rTMS)

About this trial

This is an interventional basic science trial for Depression focused on measuring Major Depression, Major Depressive Disorder, TMS, rTMS

Eligibility Criteria

22 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Primary diagnosis of major depressive disorder
Male and female subjects, ages 22-65
Have failed at least 1 antidepressant medication at adequate dose and duration
On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy

Exclusion Criteria:

Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
Active substance abuse, including alcohol
Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
Pregnant or trying to get pregnant
Failed to respond to an adequate course of electroconvulsive therapy (ECT)
Previous treatment with TMS
Current depressive episode longer than 5 years

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.

20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.

Outcomes

Primary Outcome Measures

Depressive Symptoms at 4 Weeks

MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Secondary Outcome Measures

Depression Symptoms at 4 Weeks- Secondary

Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22

Full Information

NCT ID

NCT01900314

First Posted

July 11, 2013

Last Updated

April 20, 2017

Sponsor

University of Michigan

Collaborators

National Institute of Mental Health (NIMH), Neuronetics

1. Study Identification

Unique Protocol Identification Number

NCT01900314

Brief Title

Imaging Biomarkers for TMS Treatment of Depression

Official Title

Imaging Biomarkers for TMS Treatment of Depression

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

September 2013 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

National Institute of Mental Health (NIMH), Neuronetics

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

Keywords

Major Depression, Major Depressive Disorder, TMS, rTMS

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active rTMS

Arm Type

Active Comparator

Arm Description

Arm Title

Sham rTMS

Arm Type

Sham Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

repetitive Transcranial Magnetic Stimulation (rTMS)

Other Intervention Name(s)

TMS, NeuroStar, Sham treatment

Intervention Description

20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.

Primary Outcome Measure Information:

Title

Depressive Symptoms at 4 Weeks

Description

MADRS: Montgomery Asberg Depression Rating Scale Range: 0 - 60 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression

Time Frame

4 weeks after baseline

Secondary Outcome Measure Information:

Title

Depression Symptoms at 4 Weeks- Secondary

Description

Depressive symptoms as measured by the 17-item Hamilton Depression Rating Scale (HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22

Time Frame

4 weeks after baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Primary diagnosis of major depressive disorder Male and female subjects, ages 22-65 Have failed at least 1 antidepressant medication at adequate dose and duration On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy Exclusion Criteria: Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder Active substance abuse, including alcohol Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury; No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body; Pregnant or trying to get pregnant Failed to respond to an adequate course of electroconvulsive therapy (ECT) Previous treatment with TMS Current depressive episode longer than 5 years

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan F Taylor, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

29494898

Citation

Taylor SF, Ho SS, Abagis T, Angstadt M, Maixner DF, Welsh RC, Hernandez-Garcia L. Changes in brain connectivity during a sham-controlled, transcranial magnetic stimulation trial for depression. J Affect Disord. 2018 May;232:143-151. doi: 10.1016/j.jad.2018.02.019. Epub 2018 Feb 21.

Results Reference

derived

Links:

URL

http://umclinicalstudies.org/HUM00053677

Description

U of M Clinical Studies

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Imaging Biomarkers for TMS Treatment of Depression

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