Efficacy and Biomarkers of Response of TBS in Treatment Resistant Depression

Summary

Theta Burst Transcranial Magnetic Stimulation (TBS) in dorsolateral prefrontal cortex (DLPFC) has shown efficacy and safety as an adjuvant strategy for resistant to treatment depression (RTD) in daily sessions during 4-6 weeks (20-30 sessions). Current investigation in TBS aims to design intensive treatment protocols so as to achieve earlier responses and higher rates of efficacy. However, the implementation of TBS in the Public National Health Service requires cost-effective protocols that ensure and facilitate patients adherence to treatment, and whose design is based on clinical and neuroimaging biomarkers of response so as to adequately select candidate patients. The aim of this study is to assess the efficacy and safety of novel bilateral and unilateral intensive and spaced protocols of TBS in outpatients with unipolar and bipolar RTD compared with sham stimulation. Specific objectives: I) Comparison of mood change, response and remission of depressive illness at the end of TBS protocol in the groups and maintenance of its effect at 3 months; II) Characterization of neuroimaging cerebral connectivity networks and cerebral metabolism patterns of patients with RTD related to the effects of bilateral or unilateral TBS; III) Identification of clinical and demographic predictors contributing to response to TBS; IV) Analysis of the interaction between clinical, demographic and neuroimaging predictors so as to determine a RTD profile of patient that can benefit from TBS.

Conditions

• Resistant Depression, Treatment
• Bipolar Depression

Interventions

DEVICE

Theta Burst Transcranial Magnetic Bilateral Stimulation

TMS protocol of 22 sessions of bilateral active 1800 pulses.

DEVICE

Theta Burst Transcranial Magnetic Sham Stimulation

TMS protocol of 22 sessions of sham bilateral 1800 pulses.

DEVICE

Theta Burst Transcranial Magnetic Unilateral Stimulation

TMS protocol of 22 sessions of left active 1800 pulses and right sham 1800 pulses.

Sponsors & Collaborators

• Spanish Agency of Medicines and Health Products

  collaborator OTHER_GOV

• Hospital Universitario La Fe

  collaborator OTHER

• Instituto de Salud Carlos III

  collaborator OTHER_GOV

• Instituto de Investigacion Sanitaria La Fe

  lead OTHER

Principal Investigators

• Pilar Sierra San Miguel, PhD · Instituto de Investigación Sanitaria La Fe

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-15

Primary Completion

2025-02-28

Completion

2025-02-28

FDA Device

Yes

Countries

• Spain

Study Locations