Validation of a Quality of Life Assessment Tool in Generalized Dystonodyskinetic Syndromes Treated With Continuous Electrical Neuromodulation (CEN): The "Dystono-dyskinetic BrethoméSanrey Quality of Life" Scale (DBS-QoLs)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Ability to perform different activities assessed by DBS-QOLs
研究概览
简要总结
In spite of a growing interest in the evaluation of health-related quality of life in movement's disorders management, there is no tool specifically dedicated to dystonia and related syndromes that measures both the objective severity of the handicap and the patient's feelings about the surgical treatment in terms of subjective improvement. We have been working for several years at the bedside of patients operated on in the " pathologies cérébrales résistantes " Unit on the development of a related questionnaire to assess both the motor severity and the patients' feelings about the evolution of their disease under Deep Brain Stimulation (DBS).
The self-questionnaire designed would allow to a certain extent to get away from the two gold standards currently used in the field, i.e. the Burke, Fahn & Marsden Dystonia Rating Scale (BFMDRS) and the SF-36, thus facilitating the evaluation and allowing a homogenization of the practices for the different implanting centers on the french territory.
详细描述
The construction of the tool in its particular design, including various targeted modules, stems from an experience of more than ten years acquired with patients treated by deep brain stimulation in the unit. The self-questionnaire thus obtained will be sent to 146 patients with generalized dystonodyskinetic syndrome, operated and followed in the unit, and submitted to various statistical analyses. The scores of the identified dimensions will be compared with the etiology of the abnormal movements (primary vs. secondary) as well as with the results obtained with the two scales currently used to evaluate abnormal movements (BFMDRS) and/or quality of life (SF-36) and finally with the patients' mood during their follow-up (BDI, STAI). Tolerance to surgery will also be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adulte between 18 an 80 years
- •Patient with a generalized dystono-dyskinetic syndrome treated by Electrical Neuromodulation Continue and follow-up in the unit
- •Subject affiliated to the French social security system
排除标准
- •non-French speaker
- •patients who are physically unable to answer the questionnaire and who have no trusted person to help
- •severe cognitive impairment (MoCA <10, MDRS <123, PM-38 <70)
- •lack of informed consent
研究组 & 干预措施
Adults with dystono-diskinetic syndrome treated by depp brain stimulation in the unit.
干预措施: Questionnaire (DBS-QoLs) (Other)
结局指标
主要结局
Ability to perform different activities assessed by DBS-QOLs
时间窗: 1 year
Ability to perform different activities assessed by the Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale (DBS-QOLs) with the evaluation of the ability to perform different activities (from impossible to autonomous) and then to estimate the evolution of this ability since the intervention (worsening, no change, improvement)
Psycho-social assessment by DBS-QOLs
时间窗: 1 year
Psychosocial assessment by the "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no/partially questions related to the emotional and psychological perception of patients and then to estimate the evolution of this thought since the intervention (worsening, no change, improvement)
Life's Quality assessment by DBS-QOLs
时间窗: 1 year
Life's Quality assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with squales from 0 (worst case) to 10 (best case).
Intervention's assessment by DBS-QOLs
时间窗: 1 year
Intervention's assessment by "Dystono-dyskinetic Brethomé-Sanrey Quality of Life scale" (DBS-QOLs) with yes/no question related to the intervention.
次要结局
- External validity according to different clinical criteria or scales : sensitivity to change(1 year)
- Assessment of the correlation between the functional fain & the benefit felt by the patient with the DBS-QOLs(1 year)
- External validity of the DBS-QOLs compared to the BFMDRS for the functional subscale(1 year)
- External validity of the DBS-QOLs compared to the Beck Depression Inventory score for Thumia(1 year)
- External validity of the DBS-QOLs compared to the SF-36 for Life's quality(1 year)
- External validity of the reproducibility of the DBS-QOLs compared to the BFMDRS(1 year)
- Assessment of the tolerance to surgery by the DBS-QOLs(1 year)