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Pilot Study Comparing 10hz vs Theta Burst Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02800226
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
Fidel Vila-Rodriguez, University of British Columbia

Brief Summary:
This pilot study aims at exploring the efficacy of iTBS compared to 10Hz protocol and explore potential biomarkers of treatment response

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: 10Hz Device: iTBS Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study Comparing 10Hz Repetitive Transcranial Magnetic Stimulation (rTMS) vs. Intermittent Theta Burst Stimulation (iTBS) for Treatment Resistant Depression
Study Start Date : March 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 10Hz
High Frequency Left repetitive transcranial magnetic stimulation five days per week for 4-6 weeks
Device: 10Hz
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System

Active Comparator: iTBS
intermittent Theta Burst Stimulation (iTBS) five days per week for 4-6 weeks
Device: iTBS
Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System




Primary Outcome Measures :
  1. Change in the Hamilton Depression Rating scale 17-item (HDRS-17) score [ Time Frame: baseline, 1, 4, and 12 weeks post-treatment ]
    A 50% improvement in the score is considered response to rTMS. A final score of <8 is categorized as remission.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • outpatients
  • voluntary and competent to consent
  • Mini-International Neuropsychiatric Interview (MINI) confirmed diagnosis of Major Depressive Disorder (MDD), single, recurrent between ages 18-65
  • failed to achieve a clinical response to an adequate dose of an antidepressant based on an Antidepressant Treatment History Form (ATHF) score of ≥ 3 in the current episode or have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF 1 or 2)
  • have a score of ≥ 18 on the Hamilton Depression Rating Score 17-item (HDRS-17)
  • have had no increase or initiation of any psychotropic medication in the 4 weeks prior to screening able to adhere to the treatment schedule
  • Pass the TMS adult safety screening (TASS) questionnaire
  • have normal thyroid functioning based on pre-study blood work

Exclusion Criteria:

  • have a history of substance dependence or abuse within the last 3 months
  • have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump
  • have active suicidal intent
  • are pregnant
  • have a lifetime MINI diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms
  • have a MINI diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than MDD

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): NCT02800226


Locations
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Canada, British Columbia
Non-Invasive Neurostimulation Therapies lab, University of British Columbia
Vancouver, British Columbia, Canada, V6T2A1
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Fidel Vila-Rodriguez, MD University of British Columia
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fidel Vila-Rodriguez, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02800226    
Other Study ID Numbers: H13-02340
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: August 10, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders