Personalized Transcranial Magnetic Stimulation Treatment for Depression

Depression Clinical Trial

— APIC-TMS  

Official title:

Personalized Transcranial Magnetic Stimulation Treatment for Depression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341803
• Other study ID #: DSRB 2023/00397
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Institute of Mental Health, Singapore
• Contact: Phern Chern Tor, MBBS
• Phone: 63892000
• Email: phern_chern_tor[@]imh.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This proposal seeks to conduct a pragmatic single arm, open label pilot implementation to validate our individualized functional Magnetic Resonance Imaging (fMRI) connectome-guided localization approach for accelerated TMS among Asian patients with depression.

Participants will be patients with Major Depressive Disorder not responding to standard treatment, with no exclusions to fMRI or transcranial magnetic stimulation (TMS) (essentially metal implants in the head) and willing to participate in the pilot.

All participants will undergo MRI scans before and after the accelerated TMS treatment. The multi-session hierarchical Bayesian model (MS-HBM) approach will be used to estimate individualized connectome-guided target locations.

Patients will undergo accelerated TMS applied to individualized connectome-guided target locations (based on the MS-HBM approach).

Patients will undergo 10 sessions (each session lasting 10 min) spread out over 10 hours each day for 5 consecutive working days.

All clinical outcome data will be collected for each patient by a pre-defined questionnaire at four time points: at baseline, post-treatment, 1 month and 3 months during follow-up.

The clinical outcome data will be analyzed using linear regression or repeated analysis of variance (ANOVA) after adjusting for baseline clinical characteristics and socio-demographics. Trajectories of the clinical outcome data at baseline, post-treatment and all follow-up time points will be plotted and compared with time series statistical analysis models with the other clinical and socio-demographic characteristics included as confounders.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Individually Neuronavigated accelerated intermittent theta burst stimulation with Magpro X100
MagproX 100 and Axilium Cobot with Localite camera

Locations

Country	Name	City	State
Singapore	Institute of Mental Health	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Mental Health, Singapore	National University of Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation of changes in functional connectivity with changes in MADRS scores		Baseline, immediately post treatment
Primary	Montgomery-Åsberg Depression Rating Scale (MADRS)	Clinician rated Depression rating scale, range of scores 0 to 60 with higher scores meaning a worse outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary	Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-16)	Patient rated Depression rating scale, scored 0-27 with higher scores meaning a worse outcome	Baseline, (Days 1-5 of treatment), immediately after intervention, 1 month and 3 months post intervention
Secondary	Montreal Cognitive Assessment (MoCA),	global cognitive functioning, scored 0 to 30 with higher scores meaning better outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary	EuroQol- 5 Dimension (EQ-5D)	Quality of life scales, Visual analogue scale 0-100 with higher scores meaning better outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention
Secondary	Quality of Life Enjoyment and Satisfaction Questionnaire Short form (Q-LES-QS-SF)	Quality of life scales, scored 0-70 with higher scores meaning better outcome	Baseline, immediately post treatment, 1 month and 3 months post intervention