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

Not Applicable

Recruiting

• Conditions: Depression
• Interventions: Device: Beam F3 targeted accelerated iTBS; Device: Individualized connectome-guided accelerated iTBS

• Registration Number: NCT06385223
• Lead Sponsor: Institute of Mental Health, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-25
• Status Verified: 2024-06
• Study Start: 2024-07-01
• Last Update Submitted: 2024-07-30
• Last Update Posted: 2024-08-01
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beam F3 targeting of accelerated iTBS	Beam F3 targeted 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.
Individualized connectome-guided accelerated iTBS	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.

Primary Outcome Measures

Name	Time	Method
Montgomery-Åsberg Depression Rating Scale	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

Secondary Outcome Measures

Name	Time	Method
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	Participant rated depression rating scale, scored 0-27, higher scores mean worse outcome
EQ-5D (EuroQol)	Baseline, immediately post treatment, 1 month and 3 months post intervention	Quality of life scales, scored 0-100, higher scores mean better outcome
Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)	Baseline, immediately post treatment, 1 month and 3 months post intervention	Quality of life scales, scored 14-70, higher score means better outcome
Montreal Cognitive Assessment (MoCA)	Baseline, immediately post treatment, 1 month and 3 months post intervention	global cognitive functioning, scored 0-30, higher score means better outcome

Trial Locations

Locations (1)

Institute of Mental Health; 🇸🇬 Singapore, Singapore