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临床试验/NCT06178731
NCT06178731Unknown不适用

Virtual Reality Reward Training and Transcranial Magnetic Stimulation for Depression

Sunnybrook Health Sciences Centre1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2021年10月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
34
试验地点
1
主要终点
The Hamilton Depression Rating Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •1. Female or male patients between ages 18-65
  • •Diagnosis of major depressive disorder as defined by the Diagnostic and Statistical Manual fifth edition (DSM-5)
  • •Hamilton Rating Scale for Depression (17-item) score of at least 16
  • •Clinically significant anhedonia as defined by a Smith-Hamilton Pleasure Scale (SHAPS) score of at least 20 (Krystal et al., 2020)
  • •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
  • •Ability to provide informed consent and comply with all testing, follow-ups and study appointments and protocols

排除标准

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

研究组 & 干预措施

Virtual reality + rTMS

Experimental

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.

干预措施: rTMS (Device)

Virtual reality + rTMS

Experimental

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.

干预措施: Virtual Reality (Other)

Virtual reality sham + rTMS

Sham Comparator

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.

干预措施: rTMS (Device)

Virtual reality sham + rTMS

Sham Comparator

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.

干预措施: Virtual Reality (Other)

结局指标

主要结局

The Hamilton Depression Rating Scale

时间窗: up to 4 weeks after treatment

Mood symptoms, higher scores mean worse outcome. Min = 0, Max = 52

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Peter Giacobbe

Psychiatrist, Scientist

Sunnybrook Health Sciences Centre

研究点 (1)

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