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

July 30, 2024 updated by: Institute of Mental Health, Singapore

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Beam F3 targeting of accelerated iTBS

Patients will receive anatomically-guided (Beam F3) accelerated iTBS.

Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines.
Device: Beam F3 targeted accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera
Experimental: Individualized connectome-guided accelerated iTBS

Patients will receive individualized connectome-guided accelerated iTBS.

Participants will receive an accelerated iTBS treatment delivered with a MagVenture MagPro X100 system (MagVenture A/S, Denmark) equipped with a butterfly shaped MagVenture Cool-B65 A/P coil. The treatment course is comprised of 10 treatment sessions daily for 5 consecutive workdays for a total of 50 sessions. Each iTBS session is approximately 10 minutes (depth corrected Resting Motor Threshold of 90%, 60 cycles of 10 bursts of three pulses at 50 Hz, repeated at 5 Hz; 2s on and 8s off; 1800 pulses per session; with a 50-minute interval between sessions). All iTBS sessions will be performed by staff trained and credentialed in TMS according to Singapore College of Psychiatrists guidelines.
Device: Individualized connectome-guided accelerated iTBS
Magpro X100, Axilium Cobot, Localite camera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Åsberg Depression Rating Scale
Time Frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Clinician rated depression rating scale, Scored 0 to 60, higher scores mean worse outcome
Baseline, immediately post treatment, 1 month and 3 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)
Time Frame: Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention
Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome
Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention
Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
global cognitive functioning, scored 0-30, higher score means better outcome
Baseline, immediately post treatment, 1 month and 3 months post intervention
EQ-5D (EuroQol)
Time Frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Quality of life scales, scored 0-100, higher scores mean better outcome
Baseline, immediately post treatment, 1 month and 3 months post intervention
Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)
Time Frame: Baseline, immediately post treatment, 1 month and 3 months post intervention
Quality of life scales, scored 14-70, higher score means better outcome
Baseline, immediately post treatment, 1 month and 3 months post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TMS induced changes in resting-fMRI functional connectivity
Time Frame: Baseline, immediately post treatment
The investigators will also perform additional exploratory posthoc analyses by analysing brain imaging changes before and after TMS
Baseline, immediately post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Mental Health, Singapore

Collaborators

National University of Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 5, 2024

First Submitted That Met QC Criteria

April 23, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

August 1, 2024

Last Update Submitted That Met QC Criteria

July 30, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRB 2023/00680

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Beam F3 targeted accelerated iTBS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe