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Brainsway DTMS for Treatment of MDD Using iTBS

NCT ID: NCT04679753

Last Updated: 2020-12-23

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

PHASE4

Total Enrollment

177 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-07-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Major Depressive Disorder

Keywords

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intermittent Theta Burst Stimulation iTBS Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Brainsway Deep TMS with intermittent Theta Burst Stimulation (iTBS)
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Group Type ACTIVE_COMPARATOR

Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Intervention Type DEVICE

Brainsway DTMS with iTBS

Brainsway DTMS with High Frequency Stimulation (HF)

Brainsway DTMS with High Frequency Stimulation (HF)

Group Type ACTIVE_COMPARATOR

Brainsway DTMS with High Frequency (HF) Stimulation

Intervention Type DEVICE

Brainsway DTMS with HF

Interventions

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Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)

Brainsway DTMS with iTBS

Intervention Type DEVICE

Brainsway DTMS with High Frequency (HF) Stimulation

Brainsway DTMS with HF

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Outpatients
* Diagnosis of Major Depression Disorder

Exclusion Criteria

* Other significant Axis I psychiatric disorder with greater impairment than MDD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brainsway

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Oluremi Adefolarin, MD

Role: PRINCIPAL_INVESTIGATOR

SynapseTMS

Locations

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SynapseTMS

Yorkton, Saskatchewan, Canada

Site Status

Countries

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Canada

Other Identifiers

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CTP-0001-03

Identifier Type: -

Identifier Source: org_study_id