Are Changes in Pain Perception Associated With Changes in Brain Activity Patterns in Persons With Spinal Cord Injury and Neuropathic Pain After a Virtual Walking Training Program - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change of N-Acetyl-Aspartate in the anterior cingulate cortex
研究概览
简要总结
The aim of this pilot study is to explore the association of changes in pain perception with changes in brain activity (functional Magnetic Resonance Imaging (fMRI)) and metabolic (Magnetic Resonance Spectroscopy (MRS)) patterns of individuals with SCI and chronic NeP after a Virtual Walk (VW) therapy. The brain activity patterns will be assessed in resting state and under a specific task, before and after a VW training program, done as part of the clinical routine, as well as at a four weeks follow-up.
The results of this pilot study will serve as basis for a bigger project that aims to investigate and compare brain activity and long-term effects of non-immersive VW therapy on chronic NeP in individuals with SCI (traumatic SCI with chronic NeP at- or below level, complete or incomplete) taking into account confounding factors such as time since injury, level of injury and type of NeP.
详细描述
This pilot study consists of specific assessments at four different time points (T0=screening, T1=baseline, pre measurement, T2=post measurement, T3=four week follow-up).
The physiotherapeutical assessment at T0 involves the evaluation of the imagery capacity. At T1, the participant will be assessed for baseline measures before starting with the VW training. At T2 (after the last VW training) and at T3 (four weeks after the last VW training), the participant will be assessed for outcome measures.
Sociodemographic and clinical characteristics (age, sex, education level, workability, age at injury, lesion level, comorbidities, complications, concomitant injuries, SCI pain basic dataset 2.0 and medication) will be collected in the screening/recruitment phase but only used after receiving informed consent from each participant.
Participants will undergo a non-invasively MRI examination without application of contrast agents. The functional activity of the brain will be assessed by a blood oxygenation level-dependent (BOLD) fMRI. The metabolic profile will be assessed non-invasively by means of single voxel MRS. Prior to the fMRI and MRS measurements, a high-resolution anatomical MRI will be performed, which serves for tissue segmentation and planning purposes.
The MRI will consist out of the following sequences conducted in an MRI scanner (six minutes duration each):
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Passed neurological, physiotherapeutic and psychological assessments and team decision to take part on VW
- •Traumatic SCI (> 1 year) confirmed by MRI or CT
- •Neuropathic at or below level spinal cord injury pain for at least 3 months diagnosed by a neurologist following the CanPain Clinical Practice Guidelines and ISCIP classification
- •Good German skills (understand questionnaires and instructions)
- •Ability to draw with a pen
- •Ability to swing the arms
排除标准
- •Claustrophobia
- •Non-acceptance of the paraplegia
- •Psychiatric disorders
- •Other neurological, psycho-logical or cognitive impairments
- •Pregnancy
- •Spasticity that would interfere with MRI
- •Extensive dose of opioids
结局指标
主要结局
Change of N-Acetyl-Aspartate in the anterior cingulate cortex
时间窗: Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3)
Non-invasive MRI-based metabolic marker measured under various conditions (resting state, painful images, non-painful images)
次要结局
- Pain diary(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Depression, Anxiety & Stress Scale(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Alteration of myo-Inositol(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Chronic pain grading scale(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Pain catastrophizing scale(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Change of Choline(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Alteration of Creatine(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- BOLD signal changes during task-based and resting state functional MRI(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Pain description list(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- WHO-QoL-BREF(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- The Marburg questionnaire on habitual health findings(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- SCI independence measure III - self-reported version(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))
- Patient Global Impression of Change(Two measurement time points: only T2 (six weeks after baseline) and T3 (ten weeks after baseline)))
- Questions about pain chronification(Three measurement time points: Baseline (T1), six weeks after baseline (T2), ten weeks after after baseline (T3))