Brainsway DTMS for Treatment of MDD Using iTBS

Major Depressive Disorder Clinical Trial

Official title:

Brainsway Deep TMS System for Treatment of Major Depressive Disorder (MDD) Using Intermittent Theta Burst Stimulation (iTBS) Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04679753
• Other study ID #: CTP-0001-03
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2019
• Est. completion date: July 1, 2020

Study information

• Verified date: December 2020
• Source: Brainsway
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Outpatients

• Diagnosis of Major Depression Disorder

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Device:
• Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)
Brainsway DTMS with iTBS
• Brainsway DTMS with High Frequency (HF) Stimulation
Brainsway DTMS with HF

Locations

Country	Name	City	State
Canada	SynapseTMS	Yorkton	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
Brainsway

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure was the change from baseline in HDRS-21 scores at the 5 week visit.	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.	5 weeks
Secondary	HDRS-21 Response and Remission rates	Evaluation of the response and remission rates based on HDRS-21 scores	5 weeks
Secondary	Change in CGI-S score from baseline at the 6 week visit	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.	6 weeks
Secondary	CGI-S Response and Remission rates	Evaluation of the response and remission rates based on CGI-S scores	6 weeks