Neuromodulation in COVID-19 Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Incidence of adverse events related to treatment (safety)
研究概览
简要总结
This clinical study is aimed at investigating the effects of transcranial direct current stimulation (tDCS) on COVID-19 patients not admitted to the intensive care unit. The tDCS is a non-invasive brain stimulation technique which applies a low intensity electrical current in order to modulate neuronal activity. Patients included will be submitted to a single session with active or sham tDCS, aiming to modulate prefrontal or supplementary motor area (SMA). Evaluation protocol will be performed before and after stimulation to verify the incidence of adverse events related to treatment and whether tDCS would affect measures of executive functioning, mood, anxiety, autonomic response and motor function in COVID-19 patients. We hypothesize the neuromodulation would be a safety, promising treatment to reduce possible impairments in COVID-19 patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •suspected or confirmed diagnosis for SARS-CoV-2;
- •ability to understand and execute the proposed protocol;
- •vital signs (body temperature <38ºC, blood pressure between 90 x 60mmHg and 140 x 90 mmHg, respiratory rate between 12 e 30 bpm).
排除标准
- •dyspnea or signs of respiratory effort;
- •SpO2 ≤ 90%;
- •hemodynamic instability;
- •deep vein thrombosis, active bleeding, use of cardiac pacemaker;
- •injury, pain or metallic implants in the cranium or scalp;
- •seizure history;
- •suspected or confirmed pregnancy;
- •concomitant or previous rheumatic or neurological diseases;
- •severe psychiatric diseases (schizophrenia, bipolar disorder, intellectual disability);
- •severe musculoskeletal and/or integumentary disorders;
- •severe psychiatric disorders;
- •severe liver or kidney disease.
结局指标
主要结局
Incidence of adverse events related to treatment (safety)
时间窗: post-treatment (up to one hour after the end of the treatment)
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Change from baseline autonomic response at the end of the treatment
时间窗: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Heart rate variability (HRV) parameters change from pre-treatment to post-treatment
Change from baseline Trial Making Test (TMT) score at the end of the treatment
时间窗: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Trial Making Test (TMT) score changes from pre-treatment to post-treatment
Change from baseline Digit span score at the end of the treatment
时间窗: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Digit span score changes from pre-treatment to post-treatment
Change from baseline gait parameters at the end of the treatment
时间窗: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Gait parameters change from pre-treatment to post-treatment
Change from baseline balance parameters at the end of the treatment
时间窗: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Balance parameters change from pre-treatment to post-treatment
次要结局
- Change from baseline Functional Status Score for the intensive care unit (FSS-ICU) at the end of the treatment(pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment))
- Change from baseline Functional Reach Test (FRT) distances at the end of the treatment(pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment))
- Change from baseline Beck Anxiety Inventory (BAI) score at the end of the treatment(pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment))
- Change from baseline Beck Depression Inventory-II (BDI-II) score at the end of the treatment(pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment))