RecruitingNot ApplicableNCT06385223

A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression

A Novel Individualized Connectome-guided Approach for Precision Intermittent Theta Burst Stimulation for Depression: a Double Blind, Randomized Controlled Trial


Sponsor

Institute of Mental Health, Singapore

Enrollment

70 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The Investigators propose to carry out a randomized, double-blind trial to compare the clinical efficacy of an individualized connectome-guided accelerated iTBS vs an anatomically-guided (Beam F3) accelerated iTBS. The study team will recruit both inpatients and outpatients who had been referred for TMS for the treatment of depression.


Eligibility

Min Age: 21 Years

Inclusion Criteria5

  • Age ≥ 21 years.
  • DSM-5 diagnosis of current Major Depressive Episode.
  • Montgomery-Asberg Depression Rating Scale score of 20 or more.
  • Inadequate response to an adequate trial (4 weeks) of at least one antidepressant medication.
  • Able to give informed consent.

Exclusion Criteria7

  • DSM-5 psychotic disorder
  • Drug or alcohol abuse or dependence (preceding 3 months).
  • Rapid clinical response required, e.g., high suicide risk.
  • Significant neurological disorder, which may pose increased risks with TMS, e.g., epilepsy.
  • Metal in the cranium, skull defects, pacemaker, cochlear implant, medication pump or other electronic device.
  • Pregnancy.
  • Unsuitable for MRI.

Interventions

DEVICEBeam F3 targeted accelerated iTBS

Magpro X100, Axilium Cobot, Localite camera

DEVICEIndividualized connectome-guided accelerated iTBS

Magpro X100, Axilium Cobot, Localite camera


Locations(1)

Institute of Mental Health

Singapore, Singapore

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NCT06385223


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