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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Sponsored by
Cervel Neurotech, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depression, MDD, Transcranial Magnetic Stimulation, Depressive Disorder, TMS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Emory University
  • Rush Medical College
  • Medical University of South Carolina
  • Monash Alfred Psychiatry Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Coil Configuration A

Coil Configuration B

Arm Description

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

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

Outcomes

Primary Outcome Measures

Remission from depression
Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post

Secondary Outcome Measures

Safety and tolerability of rTMS
Determined by presence and absence of adverse events recorded daily

Full Information

First Posted
September 6, 2011
Last Updated
May 15, 2014
Sponsor
Cervel Neurotech, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01431001
Brief Title
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
Official Title
Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cervel Neurotech, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Depression, MDD, Transcranial Magnetic Stimulation, Depressive Disorder, TMS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coil Configuration A
Arm Type
Experimental
Arm Description
Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Arm Title
Coil Configuration B
Arm Type
Experimental
Arm Description
Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Intervention Type
Device
Intervention Name(s)
Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
Intervention Description
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
Primary Outcome Measure Information:
Title
Remission from depression
Description
Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post
Time Frame
baseline through 4 weeks post
Secondary Outcome Measure Information:
Title
Safety and tolerability of rTMS
Description
Determined by presence and absence of adverse events recorded daily
Time Frame
baseline through 4 weeks post

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AnnaMarie Daniels
Organizational Affiliation
Cervel Neurotech
Official's Role
Study Chair
Facility Information:
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Rush Medical College
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Monash Alfred Psychiatry Research Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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