Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression

NCT ID: NCT01431001

Last Updated: 2014-05-19

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-10-31

Brief Summary

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The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Coil Configuration A

Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Group Type EXPERIMENTAL

Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Intervention Type DEVICE

The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device

Coil Configuration B

Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Group Type EXPERIMENTAL

Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Intervention Type DEVICE

The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device

Interventions

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Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Major depressive disorder (MDD)
* Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode.
* Will not become pregnant during study.

Exclusion Criteria

* Seizure disorder.
* History of brain injury or active CNS disease.
* Metal implants on or in brain, spinal cord, ear, eye or heart.
* Current use of proconvulsant medications (e.g., bupropion).
* Other significant psychiatric disorder.
* Substance use disorder (not including caffeine or nicotine).
* 7 or more failed treatment attempts for depression in one's lifetime.
* Have failed to clinically remit to an adequate trial of ECT or TMS.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cervel Neurotech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AnnaMarie Daniels

Role: STUDY_CHAIR

Cervel Neurotech

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Rush Medical College

Chicago, Illinois, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, Australia

Site Status

Countries

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United States Australia

Other Identifiers

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NS-CPS-TRMD-1

Identifier Type: -

Identifier Source: org_study_id

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