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Brainsway DTMS for Treatment of MDD Using iTBS

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: NCT04679753
Recruitment Status : Completed
First Posted : December 22, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Brainsway

Study Description
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Brief Summary:
The safety and effectiveness of the BrainsWay deep transcranial magnetic stimulation (DTMS) device for the intended use of Major Depressive Disorder (MDD) using the intermittent theta-burst (iTBS) stimulation protocol will be evaluated in a non-inferiority study, comparing the iTBS treatment with the FDA cleared, (510(k) No. K122288) Brainsway DTMS device to the High Frequency (HF) protocol using the same device.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Device: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS) Device: Brainsway DTMS with High Frequency (HF) Stimulation Phase 4

Detailed Description:

The purpose of the study is to evaluate the safety and efficacy of Brainsway Deep TMS for the treatment of Major Depressive Disorder using the iTBS stimulation protocol, by comparing it to clinical data collected in the Brainsway randomized, controlled Multicenter study (CTP-001-00), using the HF DTMS stimulation protocol used in support of the Brainsway DTMS device 510(k) K122288.

In the post-marketing study, patients will be treated with an intermittent theta burst (iTBS) protocol, using the same Brainsway DTMS device with the same H1-Coil. Furthermore, the treatment paradigm is the same, consisting of TMS sessions performed daily for 5 weeks (20 DTMS sessions). The iTBS stimulation protocol consists of bursts of 3 pulses at 50 Hz, 5 Hz bursts frequency, 2s on and 8s off, 600 pulses per session. The HF stimulation protocol was delivered at 18 Hz, 120% stimulation intensity of the resting MT, 55 trains of 2s duration, inter-train interval (ITI) of 20s, for 1980 pulses per session.

The clinical study design includes multiple measurements of safety and effectiveness parameters.

The primary outcome measure is the change from baseline in HDRS-21 scores at the 5 week visit (after 20 treatment sessions). The success criteria of the study is a non-inferiority margin of 3.0 points.

The secondary efficacy endpoints of the study include evaluation of the response and remission rates, based on HDRS-21 scores, at the 5 week visit, change in CGI-S score from baseline to 6 weeks and response and remission rates based on CGI-S scores at the 6 week visit.

Safety will be assessed at each treatment visit. Patients will be asked to report any adverse event since their previous visit.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Brainsway Deep TMS with intermittent Theta Burst Stimulation (iTBS)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brainsway Deep TMS System for Treatment of Major Depressive Disorder (MDD) Using Intermittent Theta Burst Stimulation (iTBS) Protocol
Actual Study Start Date : January 1, 2019
Actual Primary Completion Date : July 1, 2020
Actual Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)
Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)
 Device: Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)
Brainsway DTMS with iTBS
Active Comparator: Brainsway DTMS with High Frequency Stimulation (HF)
Brainsway DTMS with High Frequency Stimulation (HF)
 Device: Brainsway DTMS with High Frequency (HF) Stimulation
Brainsway DTMS with HF


Outcome Measures
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Primary Outcome Measures :
  1. The primary outcome measure was the change from baseline in HDRS-21 scores at the 5 week visit. [ Time Frame: 5 weeks ]
    Hamilton Depression Rating Scale (HDRS-21 items), where minimum score is 0 and maximum score is 53, and where higher scores mean a worse outcome. The success criteria of the study was a non-inferiority margin of 3.0 points.


Secondary Outcome Measures :
  1. HDRS-21 Response and Remission rates [ Time Frame: 5 weeks ]
    Evaluation of the response and remission rates based on HDRS-21 scores

  2. Change in CGI-S score from baseline at the 6 week visit [ Time Frame: 6 weeks ]
    Clinical Global Improvement - Severity Scale (CGI-S), where minimum score is 1 and maximum score is 7, and where higher scores mean a worse outcome.

  3. CGI-S Response and Remission rates [ Time Frame: 6 weeks ]
    Evaluation of the response and remission rates based on CGI-S scores


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • Diagnosis of Major Depression Disorder

Exclusion Criteria:

  • Other significant Axis I psychiatric disorder with greater impairment than MDD
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): NCT04679753


Locations
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Canada, Saskatchewan
SynapseTMS
Yorkton, Saskatchewan, Canada, S3N 4C6
Sponsors and Collaborators
Brainsway
Investigators
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Principal Investigator: Oluremi Adefolarin, MD SynapseTMS
More Information
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Responsible Party: Brainsway
ClinicalTrials.gov Identifier: NCT04679753    
Other Study ID Numbers: CTP-0001-03
First Posted: December 22, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
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: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brainsway:
intermittent Theta Burst Stimulation
iTBS
Depression
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
 Mood Disorders
Mental Disorders
Behavioral Symptoms