Concurrent Transcranial Direct Current Stimulation and Motor Tasks for Chronic Pain in Adults With Cerebral Palsy: A Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- Feasibility of the protocol
研究概览
简要总结
The purpose of this study is to find out whether combining transcranial direct current stimulation (tDCS) using the Starstim tES8 device with motor-based activities, such as action observation or motor imagery (chosen based on task-fMRI results showing activation in the primary motor cortex), is a feasible treatment for chronic pain.
详细描述
The objective of this study is to determine the feasibility of using concurrent tDCS (Starstim tES8, Neuroelectrics, Spain) and motor tasks (action observation or motor imagery, according to the M1 activation during task-fMRI) to treat chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years or older
- •Diagnosis of Cerebral Palsy
- •Chronic pain associated with movement
- •Own legal decision maker
- •Current level of at least moderate pain (>=4 out of 10, as assessed by the average pain Eligibility text messages)
- •Eligible for MRI without sedation
- •Has a cellular device that can receive and respond to study text messages
- •Has stable doses of prescription medications for at least 1 month prior to study participation and no anticipated change in medication plan during the participation.
排除标准
- •Non-English speaking
- •Non-verbal
- •Implanted medical devices
- •Any metal in the head
- •Has had unexplained episodes of loss of consciousness
- •Diagnosis of epilepsy or history of seizures
- •Diagnosis of bipolar disorder, schizophrenia, or autism spectrum disorder
- •Damage of skin at sites of stimulation
- •Currently suffering from severe or frequent headaches
- •Has had a traumatic brain injury
- •Any serious life-threatening disease such as congestive heart failure, pulmonary obstructive chronic disease or active neoplasia
- •Have previously used tDCS or TMS and had an adverse reaction
- •Diagnosis of severe substance or alcohol use disorder within 3 months of enrollment
研究组 & 干预措施
Transcranial Direct-Current Stimulation
This is the arm of intervention with participant receiving MRI Scan with Action Observation or Motor Imagery, Transcranial Magnetic Stimulation Motor Cortex excitability assessment, and Transcranial Direct-current Stimulation
干预措施: Trans Cranial Direct Current Stimulation (Device)
结局指标
主要结局
Feasibility of the protocol
时间窗: 17 Days
Feasibility of study procedures will be determined based on ≥60% retention through the follow-up participant surveys, and (2) ≥60% adherence to scheduled intervention sessions.
Acceptability of the protocol.
时间窗: Through study duration, average of 24 weeks
Aim will be evaluated using the following methods: Acceptability will be measured using the Theoretical Framework of Acceptability (TFA) which is an 8-item measure used to assess intervention acceptability. Each item measures a different component of acceptability ranging from a 1-5 Likert scale.
Intervention tolerability
时间窗: From the first day of intervention to the last day of intervention, average 10 consecutive weekdays.
Tolerability will be assessed by monitoring side effects/adverse events, through structured assessments and clinical interactions. At all intervention session visits, the tDCS operator will conduct a general inquiry regarding how the participant is feeling, go through a structured assessment of potential side effects/symptoms, and visually inspect the skin at the site of stimulation for redness or irritation before and after each tDCS session. Adverse events will be coded on a standardized Adverse Events tracking form. The PI or delegated investigator will assess all adverse effects for their severity, their unexpectedness, their relation to study procedures, and whether they represent increased risk to other participants or the greater community.
Participant burden associated with the intervention
时间窗: Through study duration, average of 24 weeks
Participant burden will be quantified by asking participants to report their travel time, recording the duration of participant visits, and providing an open text box for participant feedback on study burden. These will be combined to determine the feasibility of concurrent tDCS and motor tasks for the treatment of chronic pain in adults with CP.
次要结局
- fMRI BOLD activation map volume in M1(Baseline and up to 44 days after Day 1)
- Brief Pain Inventory (BPI)(Baseline and 21 days after Day 1)
- Dallhousie Pain Interview(Baseline and 21 days after Day 1)
- Quality of Life Likert scale(Baseline and 21 days after Day 1)
- Fatigue Numeric Rating Scale(Baseline and 21 days after Day 1)
- Days Affected by Pain(Baseline and 21 days after Day 1)
- PROMIS Anxiety (Short form 8a)(Baseline and 21 days after Day 1)
- PROMIS Depression (short form 8b)(Baseline and 21 days after Day 1)
- painDETECT questionnaire(Baseline and 21 days after Day 1)
- Pain Catastrophizing Scale(Baseline and 21 days after Day 1)
- Patient Global Impression of Change(Baseline and 21 days after Day 1)
- Qualitative tDCS Outcome Questions(Baseline and 21 days after Day 1)
- Daily Average Pain Numeric Rating Scale(Through study duration, average of 24 weeks)
研究者
Mo Chen
PhD
Gillette Children's Specialty Healthcare