VIRTUAL WALKING AND TRANSCRANIAL DIRECT CURRENT STIMULATION (TDCS) FOR CHRONIC NEUROPATHIC PAIN DUE TO SPINAL CORD INJURY (SCI): A FEASIBILITY STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Patient-reported expectations, acceptability and satisfaction
研究概览
简要总结
The goal of this feasibility study is to assess the feasibility of the combined treatment intervention "virtual walking (VW) and transcranial direct current stimulation (tDCS)" of neuropathic pain in patients with spinal cord injury. The main question aims to answer:
• To assess the feasibility of combining VW and tDCS for longer-term use from the patients' point of view.
Participants will:
Receive a two week intervention in the Swiss Paraplegic Centre in Nottwil, where the participants undergo VW and tDCS for ten sessions, each lasting around 20 minutes.
The participants keep a diary and a pain drawing of their symptoms and will fill out some questionnaires about their impression of feasibility, the pain intensity, chronicity, the impression of change, depression, anxiety, stress and adverse events. At the beginning and end of the study the participants will be interviewed about their expectations, hopes and the feasibility of the procedures from a participants point of view.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18y, ≤ 75y
- •traumatic SCI (> 6 month after SCI) with a SCI severity grade AIS A, B, C or D
- •At or below level spinal cord injury neuropathic pain on trunk or lower extremities according to the ISCIP classification (Bryce et al., 2012) of at least 4/10 intensity on a NRS (Langford et al., 2023) with in the last 7 days (WiderströmNoga et al., 2023)
- •Good communication in German to understand the instructions, assessments and to fill in questionnaires
- •Adequate siting balance
- •Ability to draw with a pencil
- •Ability to swing arms
排除标准
- •severe psychiatric disorder requiring psychiatric hospitalisation or mental disease that could interfere with their ability to participate
- •Previous brain surgery
- •Metal implants in the skull or brain, including cochlear implants, intracranial electrodes or a pacemaker (Datta et al., 2010)
- •Drugs that affect cortical excitability (McLaren et al., 2018): Alcohol, Amphetamines, Theophylline (asthma treatment), Chlorpromazine, Clozapine, Amitriptyline, Doxepine, Imipramine, Maprotiline, Nortriptyline, Foscarnet, Ganciclovir, Ritonavir, Amphetamines, Cocaine, Gamma-hydroxybutyrate (GHB), Ketamine, MDMA, ecstasy Phencyclidine
- •Previous adverse effects of stimulation with tDCS
- •A scalp or skin condition (e.g. psoriasis or eczema)
- •History of epilepsy or seizure
- •Pregnancy (anamnestic)
- •Inability to give consent
结局指标
主要结局
Patient-reported expectations, acceptability and satisfaction
时间窗: one week before treatment, 2 weeks during treatment, 1 week after treatment
semistructured interview
次要结局
- Adherence rate(during 2 weeks treatment)
- Drop out rate(during 2 weeks treatment)
- Quality of pain(one week pre-treatment, one week post-treatment)
- Preparation time(during 2 weeks treatment)
- Pain distribution(From enrollment to the end of study at 4 weeks)
- Pain intensity(Daily from enrollment to the end of study at 4 weeks)
- Pain chronicity(one week pre-treatment)
- Safety of tDCS(every day during the 2 weeks treatment)
- Patient Global Impression of Change (PGIC)(one week post-treatment)
- Depression, anxiety and stress(one week pre-treatment and one week post-treatment)