Neuromodulation Using Transcranial Direct Current Stimulation (tDCS) in Post-COVID Syndrome: Comparison of Two Targets
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Fatigue Severity Scale (score)
研究概览
简要总结
The main aim of this study is to compare the effect of two non-invasive neuromodulation targets in patients meeting WHO criteria for the post-COVID condition. A randomized, parallel, double-blind study will be conducted. Patients will receive 15 neuromodulation sessions through transcranial electrical stimulation for 3 weeks, associated with cognitive stimulation during therapy. The main objective will be to evaluate the change in physical fatigue. As secondary objectives, changes in cognition, depression, pain, quality of sleep and quality of life will be evaluated. The objective of this study is to evaluate the effect of two targets (left dorsolateral prefrontal and M1) of the neuromodulation intervention, together with cognitive stimulation.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of COVID-19 at least 6 months before the participation in the study.
- •Diagnosis of post-COVID condition according to WHO criteria.
- •Age 18-65 years.
- •Spanish as native language.
- •Sign of written informed consent.
排除标准
- •History of stroke
- •History of traumatic brain injury or central nervous system infection
- •Diagnosis of other neurological or medical disorder that could impact on fatigue.
- •Diagnosis of active psychiatric disorder potentially impacting on fatigue or cognitive function.
- •Chemotherapy or radiotherapy for cancer.
- •Severe sensory deficits (e.g. visual loss) that could limit assessments included int the study protocol.
- •Taking drugs or uncontrolled medical disorder potentially causing or worsening fatigue. Specifically, uncontrolled adrenal insufficiency, miastenic syndromes, thyroid disorders, cardiac failure, chronic kidney disorders and neurodegenerative disorders are excluded.
- •History of abuse of alcohol or other toxics.
- •Any contraindication for transcranial electric stimulation: epilepsy, pregnancy, metallic implants, brain devices, pacemakers, head injuries).
结局指标
主要结局
Fatigue Severity Scale (score)
时间窗: 1 month
Physical fatigue
次要结局
- FLEI scale (score)(1 month)
- Brief Pain Inventory (score)(1 month)
- Modified Fatigue Impact Scale (MFIS) (score)(1 month)
- Beck Depression Inventory (2nd version) (score)(1 month)
- Pittsburgh Sleep Quality Index (score)(1 month)
研究者
Jordi A Matias-Guiu
PhD MD
Hospital San Carlos, Madrid