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

Institute of Mental Health, Singapore

Status: Enrolling

Conditions: Depression

Treatments: Device: Individualized connectome-guided accelerated iTBS; Device: Beam F3 targeted accelerated iTBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06385223

DSRB 2023/00680

Details and patient eligibility

About

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.

Enrollment: 70 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Beam F3 targeting of accelerated iTBS

Active Comparator group

Description:

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.

Treatment:

Device: Beam F3 targeted accelerated iTBS

Individualized connectome-guided accelerated iTBS

Experimental group

Description:

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.

Treatment:

Device: Individualized connectome-guided accelerated iTBS