Virtual Reality + rTMS for Depression

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Sunnybrook Health Sciences Centre

No Placebo Group

Trial Summary

What is the purpose of this trial?Anhedonia is a core feature of major depressive disorder (MDD) (DSM-5). Functional magnetic resonance imaging (fMRI) studies have associated anhedonia in MDD with altered frontostriatal activity and functional connectivity relative to controls. Conversely, antidepressant treatment is associated with increased ability for patients with MDD to sustain frontostriatal activity in a manner predictive of decrease in anhedonia and gains in daily positive affect. Novel interventions are needed to address anhedonia. Repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex (DLPFC) has been shown to activate striatal reward circuits. Positive Affect Treatment (PAT) was developed to treat deficits in reward processing; a critical skill patients are trained on in PAT involves recounting and savouring of positive experiences. However, amotivation impedes some patients from engaging in positive activities, prompting the development of virtual reality reward training (VR RT) for this skill. Evidence is building that brain state at the time of rTMS impacts its therapeutic effect. For example, imaginal exposure and individualized symptom provocation just prior to rTMS enhances its therapeutic effect on post-traumatic stress disorder and obsessive-compulsive disorder, respectively. It is unknown whether VR RT can augment rTMS for MDD and if so whether it is mediated by enhancing changes in frontostriatal activity or functional connectivity. The current study is significant for multiple reasons. As mentioned, there is a paucity of effective treatments for anhedonia and this study may inform development of a novel treatment strategy that harnesses findings from affective neuroscience. Recent economic analysis suggests that rTMS can be more cost-effective than pharmacotherapy or ECT for treatment-resistant depression (Ontario Health, 2021). Our findings will provide insight on ways to synergize specific psychotherapeutic techniques with targeted stimulation of brain circuits to more effectively treat subtypes of depression.

Eligibility Criteria

This trial is for adults aged 18-65 with major depressive disorder and significant anhedonia, who have been on a stable antidepressant regimen for at least four weeks. Participants must not have psychosis, mania, active neurological disease, seizure history, recent substance abuse (except caffeine/nicotine), acute suicidal thoughts or certain personality disorders.

Inclusion Criteria

I have been diagnosed with major depression.

I am between 18 and 65 years old.

I've been on the same antidepressant for at least 4 weeks and agree not to change it during the study.

+3 more

Exclusion Criteria

I have an active neurological condition.

I have undergone rTMS treatment before.

I take more than 2 mg of lorazepam or its equivalent, or I am on anticonvulsant medication.

+10 more

Participant Groups

The study tests whether virtual reality reward training can enhance the effects of repetitive transcranial magnetic stimulation (rTMS) in treating depression-related anhedonia. It explores if this combination improves mood by activating specific brain circuits associated with pleasure and reward.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Virtual reality + rTMSExperimental Treatment2 Interventions

Each treatment session involves: 12-15 min VR viewing, 15 min descriptive and imaginal recounting followed immediately by 3 min rTMS delivery with iTBS to the left DLPFC.

Group II: Virtual reality sham + rTMSPlacebo Group2 Interventions

Each treatment session involves: 12-15 min VR viewing, 15 min descriptive and imaginal recounting followed immediately by 3 min rTMS delivery with iTBS to the left DLPFC.

rTMS is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as rTMS for: