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Investigational TMS Treatment for Depression

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ClinicalTrials.gov Identifier: NCT03175887
Recruitment Status : Withdrawn (PI's discretion due to needing to modify study protocol.)
First Posted : June 5, 2017
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
Paul Holtzheimer, White River Junction Veterans Affairs Medical Center

Study Description
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Brief Summary:
This study is aimed to help us learn about the effects of Transcranial Magnetic Stimulation at the forehead versus the left side of the head for treatment of Treatment Resistant Depression.

Condition or disease Intervention/treatment Phase
Depression Treatment Resistant Depression Device: TMS Not Applicable

Detailed Description:
While transcranial magnetic stimulation (TMS) to the left dorsolateral prefrontal cortex (DLPFC) is an FDA approved treatment for depression, a growing and converging database suggests the medial prefrontal cortex (MPFC) may be even more critical to the neurobiology of depression and antidepressant treatment response. This study will compare the efficacy of high frequency transcranial madntic stimulation on these two sections of the brain.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dorsolateral Versus Medial Prefrontal TMS for Depression
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Arm
Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.
 Device: TMS
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
Treatment Arm

After the experimental arm, if a patient was randomized to the medial prefrontal cortex during the experimental arm and it did not work for them, they have the option of returning for a session of TMS to the FDA-approved dorsolateral prefrontal cortex.

If they were assigned to the dorsolateral prefrontal cortex, they are not eligible to return for another set of treatment.

 Device: TMS
Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.


Outcome Measures
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Primary Outcome Measures :
  1. Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale [ Time Frame: Change from baseline Hamilton-17 score to follow-up visit at 1 week after final TMS intervention. ]
    Depressive symptoms will be measured by the 17-item Hamilton Depression Rating Scale.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 21-70 years old
  • inadequate response to one current antidepressant medication
  • currently depressed

Exclusion Criteria:

  • psychiatric comorbidities
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175887


Locations
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United States, Vermont
White River Junction VA Medical Center
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
White River Junction Veterans Affairs Medical Center
More Information
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Responsible Party: Paul Holtzheimer, Director of Mood Disorder Services, White River Junction Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT03175887    
Other Study ID Numbers: D17107
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Paul Holtzheimer, White River Junction Veterans Affairs Medical Center:
depression
trd
treatment-resistant depression
TMS
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders