Investigational TMS Treatment for Depression

NCT ID: NCT03175887

Last Updated: 2021-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression Treatment Resistant Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Arm

Participants will receive TMS. They will be randomized to either the left dorsolateral prefrontal cortex or the medial prefrontal cortex.

Group Type EXPERIMENTAL

TMS

Intervention Type DEVICE

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.

Group Type OTHER

TMS

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* psychiatric comorbidities
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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White River Junction Veterans Affairs Medical Center

FED

Sponsor Role lead

Responsible Party

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Paul Holtzheimer

Director of Mood Disorder Services

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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White River Junction VA Medical Center

White River Junction, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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D17107

Identifier Type: -

Identifier Source: org_study_id

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