Response Predictors of Theta-burst Stimulation for Depression

NCT ID: NCT04969549

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-13
• Study Completion Date: 2023-11-28

Brief Summary

The study consists of an open label trial designed to treat adult depression with TBS. Our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (MRI) assessments at baseline and after 7-10 days of treatment onset in 70 patients. The scientific goal is to test a hypothesis about treatment action: that TBS will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks.

Detailed Description

Depressive disorders are among the leading causes of incapacity and disability worldwide. The burden of depression is expected to increase and is associated with negative impact on clinical conditions and physical and cognitive abilities. Given the limited efficacy of antidepressant drugs, novel treatments such as theta-burst brain stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), are being developed. However, to further advance the field towards treatment personalisation, increasing understanding of TBS antidepressant mechanisms and identifying treatment responders are important issues. Moreover, no studies have used neuroimaging in TBS trials in depression yet. Our group in Brazil is a leading brain stimulation centre, although neuroimaging expertise is lacking. We will conduct an open label trial designed to treat adult depression with TBS. Our aim is to build capacity in neuroimaging analyses by performing magnetic resonance imaging (MRI) assessments at baseline and after 7-10 days of treatment onset in 70 patients. The scientific goal is to test a hypothesis about treatment action: that TBS will reduce negative bias (which causally maintains negative mood) after 1 week of treatment, and patients who show this neurocognitive change will be the ones who go on to respond clinically after 6 weeks. Scientifically, this proposal and its outcomes will help advance towards next-generation precision brain stimulation, by incorporating cognitive/neuroimaging readouts that inform about mechanism and individual response.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Theta-burst stimulation (TBS)

Receive active iTBS, 1800 pulses, 100% MT over dlPFC.

Group Type: OTHER

Theta burst stimulation

Intervention Type: OTHER

It consists of 20 sessions of iTBS over the dlPFC.

Interventions

Theta burst stimulation

It consists of 20 sessions of iTBS over the dlPFC.

Intervention Type: OTHER

Other Intervention Names

TBS

Eligibility Criteria

Inclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Academy of Medical Sciences, UK

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Andre R Brunoni

Associate Professor of the Medical School of the University of Sao Paulo (FMUSP), Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andre R Brunoni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

FACULDADE DE MEDICINA DA USP

Locations

Instituto de Psiquiatria

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

NAFR12\1010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

43768721.4.0000.0068

Identifier Type: -

Identifier Source: org_study_id