Using virtual reality and brain stimulation to treat depression

Virtual Reality Reward Training and Transcranial Magnetic Stimulation for Depression

This study is testing if combining virtual reality experiences with brain stimulation can help people with major depressive disorder feel more pleasure and improve their mood.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sunnybrook Health Sciences Centre (Academic / other)
• Locations: 1 site (Toronto, Ontario)
• Trial ID: NCT06178731 on ClinicalTrials.gov

What this trial studies

This trial investigates the effectiveness and feasibility of combining virtual reality reward training with repetitive transcranial magnetic stimulation (rTMS) for patients with major depressive disorder (MDD). Participants will be randomly assigned to receive either the active treatment or a sham version, with sessions involving virtual reality experiences followed by brain stimulation. The study aims to address anhedonia, a core symptom of MDD, by enhancing reward processing through innovative therapeutic techniques. Patients will be monitored for their response to the interventions over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-65 diagnosed with major depressive disorder and experiencing clinically significant anhedonia.

Not a fit: Patients with a history of psychosis, active neurological diseases, or substance dependence may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve the treatment of anhedonia in patients with major depressive disorder.

How similar studies have performed: While the combination of virtual reality and rTMS is innovative, similar approaches targeting reward processing in depression have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

* 1. Female or male patients between ages 18-65 2. Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5) 3. Hamilton Rating Scale for Depression (17-item) score of at least 16 4. Clinically significant anhedonia as defined by a Smith-Hamilton Pleasure Scale (SHAPS) score of at least 20 (Krystal et al., 2020) 5. On a stable antidepressant regimen for at least 4 weeks before treatment which can continue during treatment and agreement to not make changes or additions to psychotropic medications during the course of their participation in the study 6. Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

Exclusion criteria:

1. Any past or current evidence of psychosis or mania
2. Active neurologic disease
3. Any lifetime history of seizures
4. Alcohol or substance dependence or abuse in the last 6 months, excluding caffeine and nicotine
5. Current active suicidal ideation
6. Personality disorder deemed to be the primary pathology
7. Taking more than 2 mg lorazepam (or an equivalent) or any anticonvulsant
8. Previous rTMS treatment
9. Lifetime history of non-response to an adequate course (minimum 8 treatments) of electroconvulsive therapy
10. Previous or current engagement in ketamine treatment for major depressive disorder
11. Any contraindication to MRI scanning
12. Likely to relocate or move out of the country during the study's duration (3-4 months from baseline visit)
13. Frequent motion sickness

Where this trial is running

Toronto, Ontario

• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)

Study contacts

• Study coordinator: Peter Giacobbe, MD, MSc, BSc

Conditions Major Depressive Disorder