Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178731
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-12-01
Brief Title:
Virtual Reality Reward Training and Transcranial Magnetic Stimulation for Depression
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Virtual Reality Reward Training and Transcranial Magnetic Stimulation for Depression
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
This is a non-blinded randomized sham-controlled trial for effectiveness and feasibility of virtual reward reality training and rTMS for MDD with two arms Patients with MDD who meet inclusion and exclusion criteria will be identified and recruited from the practices of Sunnybrook psychiatrists Subjects will undergo either i VR RT rTMS n 17 or ii VR sham rTMS n 17 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 The study will proceed according to the schedule laid out below Both patients and treating team will be aware of all treatment parameters at all times
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None