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

NCT06385223 | Recruiting

• 1 other identifier: DSRB 2023/00680
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression

Keywords

neuronavigated; iTBS; Accelerated; RCT

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale

  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 Outcomes (4)

• Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report)

  Baseline, daily during treatment (5 days), immediately post treatment, 1 month and 3 months post intervention

• Montreal Cognitive Assessment (MoCA)

  Baseline, immediately post treatment, 1 month and 3 months post intervention

• EQ-5D (EuroQol)

  Baseline, immediately post treatment, 1 month and 3 months post intervention

• Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)

  Baseline, immediately post treatment, 1 month and 3 months post intervention

Other Outcomes (1)

• TMS induced changes in resting-fMRI functional connectivity

  Baseline, immediately post treatment

Study Arms (2)

Beam F3 targeting of accelerated iTBS

ACTIVE COMPARATOR

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

Individualized connectome-guided accelerated iTBS

EXPERIMENTAL

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

Interventions

Beam F3 targeted accelerated iTBS DEVICE

Magpro X100, Axilium Cobot, Localite camera

Beam F3 targeting of accelerated iTBS

Individualized connectome-guided accelerated iTBS DEVICE

Magpro X100, Axilium Cobot, Localite camera

Individualized connectome-guided accelerated iTBS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Mental Health, Singapore: lead
• National University of Singapore: collaborator

Study Sites (1)

Institute of Mental Health

Singapore, 539747, Singapore

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Phern Chern Tor, MBBS

CONTACT

63892000; phern_chern_tor@imh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2024
• First Posted: April 25, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)