The Effectiveness of Transcranial Direct Current Stimulation (tDCS) as Adjunctive Treatment for Chronic Daily Headache in Systemic Lupus Erythematosus: A Double Blind Randomized Multi-Arm Sham Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- Headache Frequency
研究概览
简要总结
The prevalence of chronic primary headache in Systemic Lupus Erythematosus (SLE) is 54.4%. Several studies have shown that the use of transcranial direct current stimulation (tDCS) at the primary motor cortex (M1), primary sensory cortex (S1), or dorsolateral prefrontal cortex (DLPFC) is effective as adjuvant therapy in primary headache. Using a double-blind design, this clinical trial study will investigate the effectiveness of tDCS as an adjuvant therapy in chronic daily headaches in SLE, by also comparing the effectiveness of administration in the M1, S1, and DLPFC.
The primary endpoint that will be assessed is the frequency of headaches per week, with the secondary endpoints are the degree of headache, quality of life, sleep quality, level of depression, and use of analgesics.
详细描述
This study aimed to assess the effectiveness of the tDCS protocol as an adjuvant therapy for reducing chronic headache in SLE. It is also hoped that this study will obtain an effective tDCS protocol for chronic headache.
The whole procedure will run for 20 weeks, divided into 3 parts (Pre-intervention, Intervention, and Post-intervention)
Pre-intervention (weeks 0-4) to conduct screening, provide informed consent, and also baseline assessment. Participants will come in weeks 0 and 4.
Intervention (weeks 4-8) to perform the TDCS intervention, record and assess outcomes, and assess if an unwanted event occurs. Participants will come 2 times per week, from week 4 to 8
Post-intervention (weeks 8-20) for continued outcome assessment. Participants will come on weeks 8, 12, 16, and 20
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Age > 18 years old
- •Patients who have been diagnosed with SLE based on the 2019 ACR criteria
- •Meet the criteria for the diagnosis of chronic headache (criteria based on the International Headache Society, headache occurs in 15 days or more per month, occurs for at least 3 months)
排除标准
- •The patient or the patient's family refuses to participate in the study
- •Is in a state of relapse/flare
- •Allergic reactions / skin infections / wounds / cranial defects / metal implants in the electrode installation area
- •Have a history of brain tumor, severe head injury, stroke
研究组 & 干预措施
Primary Motor Cortex (M1)
Subjects were randomly assigned to receive tDCS stimulation at the primary motor cortex (M1)
干预措施: Transcranial Direct Current Stimulation (Device)
Primary Sensory Cortex (S1)
Subjects were randomly assigned to receive tDCS stimulation at the primary sensory cortex (S1)
干预措施: Transcranial Direct Current Stimulation (Device)
Dorsolateral Prefrontal Cortex (DLPFC)
Subjects were randomly assigned to receive tDCS stimulation at the dorsolateral prefrontal cortex (DLPFC)
干预措施: Transcranial Direct Current Stimulation (Device)
Sham
The sham intervention procedure was carried out similarly to the experimental group, but in the following group, the device would only conduct electric current in the first and last 30 seconds of the intervention.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Headache Frequency
时间窗: Change from baseline, at the end of weeks 8, and during the follow up period (end of weeks 12, 16, and 20)
Headache Frequency will be assessed using the headache diary, with a reduced number of frequencies, it indicates a better output
次要结局
- Frequency of use of analgesics(Change from baseline until week 8th, followed at 12th, 16th, 20th week)
- Amount of analgesic use(Change from baseline until week 8th, followed at 12th, 16th, 20th week)
- Headache Assessed by Visual Analouge Scale(Change from baseline, 4th, 5th-8th, 12th, 16th, 20th week)
- Functional Aspects of Headache-Related Quality of Life Assessed by Chronic Headache Quality of Life Questionnaire (CHQLQ)(4th, 8th, 12th, 16th, 20th week)
- Health-Related Quality of Life Assessed by The 36-Item Short Form Health Survey Questionnaire (SF-36)(4th, 8th, 12th, 16th, 20th week)
- Sleep Quality Assessed by Pittsburgh Sleep Quality Index (PSQI)(4th, 8th, 12th, 16th, 20th week)
- Depression level assessed by Mini International Neuropsychiatric Interview Version ICD-10 (MINI ICD 10)(4th, 8th, 12th, 16th, 20th week)
研究者
Riwanti Estiasari, MD, PhD
Associate Professor
Indonesia University