Cognitive Flexibility Training for Persistent Pain: Neuroimaging Pilot (COFLEX-i)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Changes in resting-state fMRI BOLD signal before and after 5 week cognitive training
研究概览
简要总结
To determine whether a 5-week computer-based cognitive training intervention results in changes in resting-state functional connectivity (rsFC) within the brain networks.
详细描述
This project is a single-center prospective pilot study to assess whether cognitive flexibility training through a Lumosity®-based training module over the course a five week timeframe in patients with chronic hip, knee, and back pain results in detectable changes in resting-state functional connectivity (rsFC). The investigators will explore changes in rsFC particularly within the default mode (DMN), frontoparietal (FPN), and cingulo-opercular (CON) brain networks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between 18 to 70 years old with chronic hip, knee or back pain for >3 months
- •Documented moderate to severe chronic pain
- •English fluency
- •Access to a computer at home and an email account
排除标准
- •Lack of email/lack of basic computer skills
- •Diagnosed Alzheimer's or documented severe cognitive impairment
- •Severely impaired vision or color blindness
- •Unable to complete cognitive testing
- •An interventional pain procedure within one week prior to enrollment testing
- •Scheduled to undergo a pain procedure during the five weeks of cognitive training
- •Self-reported claustrophobia
- •Contraindication to an MRI scan (i.e. presence of metallic foreign body such as an artificial joint or aneurism clip, implanted pacemaker or spinal cord stimulator)
研究组 & 干预措施
Cognitive Training + fMRI
Participants will complete Trail Making Test (TMT) A & B (both electronic and paper-pencil), the paper-pencil Color-Word Matching Stroop Test (CWMST), and its electronic version called "Color Match", and a computer-based subset of NCPT (Neurocognitive Performance Test). In addition, participants will also complete Brief Pain Inventory (BPI), Hospital Anxiety and Depression Scale (HADS), Pain Catastrophizing Scale (PCS), and the Resilience Scale questionnaires at baseline.
Participants will be provided with the cognitive training module and participants will be required to complete a targeted 36-minute daily training for 35 days.
Participants will be asked to undergo 2 functional magnetic resonance imaging (fMRI) sessions. One prior to, and one after the 5-week cognitive training period.
干预措施: Cognitive Training + fMRI (Behavioral)
结局指标
主要结局
Changes in resting-state fMRI BOLD signal before and after 5 week cognitive training
时间窗: 5 weeks
Changes in resting-state fMRI BOLD (blood oxygenation level dependent) signal before and after 5-week cognitive training, within the default mode, frontoparietal, and cingulo-opercular brain networks.
次要结局
- Association between change in resting-state fMRI BOLD signal and the change in NCPT following cognitive training.(5 weeks)
研究者
simon.haroutounian
Assistant Professor of Anesthsiology
Washington University School of Medicine