The Impact of Transcranial Direct Current Stimulation on Quality of Life, Brain Fog, and Fatigue in Patients With Long COVID: Study Protocol of the NEUROSTIM-LC Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Change in Health-Related Quality of Life
研究概览
简要总结
Long COVID can cause persistent symptoms such as fatigue, cognitive difficulties commonly described as brain fog, reduced exercise tolerance, and impaired quality of life. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique that may help modulate brain activity in regions involved in cognition, fatigue, and executive function.
The NEUROSTIM-LC study will evaluate the feasibility and potential effects of repeated tDCS sessions in adults with long COVID presenting fatigue and/or brain fog. Participants will receive 30 sessions of tDCS applied over the left dorsolateral prefrontal cortex. Assessments will be performed before and after the intervention to evaluate changes in quality of life, fatigue, cognitive function, brain metabolism, physical performance, autonomic function, sleep quality, psychological symptoms, respiratory function, and blood biomarkers.
详细描述
The NEUROSTIM-LC study is a prospective, single-arm, interventional before-and-after study designed to evaluate the feasibility, tolerability, and preliminary effects of transcranial direct current stimulation (tDCS) in patients with long COVID. The study will recruit adults aged 18 to 70 years diagnosed with long COVID according to World Health Organization criteria and presenting persistent fatigue and/or cognitive impairment commonly described as brain fog.
Participants will receive 30 sessions of tDCS delivered over consecutive weeks in a controlled clinical setting. Stimulation will be applied over the left dorsolateral prefrontal cortex, with the anode positioned at F3 according to the international 10-20 EEG system and the cathode over the contralateral supraorbital region. Each session will be delivered at 2 mA for 20 minutes. Sessions will be performed on weekdays under the supervision of trained healthcare professionals, and adherence, tolerability, and adverse effects will be monitored throughout the intervention period.
Assessments will be conducted at baseline and after completion of the intervention. Clinical outcomes will include health-related quality of life, fatigue, cognitive performance, sleep quality, anxiety and depression symptoms, and perceived symptom evolution. Neurobiological and physiological outcomes will include brain metabolism assessed by PET-CT, autonomic nervous system activity assessed by heart rate variability, exercise capacity assessed using the Ekblom-Bak submaximal cycle ergometer test, upper-limb muscle strength assessed by handgrip dynamometry, lower-limb neuromuscular performance assessed by countermovement jump testing, respiratory function, oxygen saturation, and routine blood biomarkers. Blood samples may also be stored for future analysis of inflammatory and oxidative stress markers.
The study aims to provide preliminary information on whether repeated tDCS may be associated with measurable improvements in fatigue, brain fog, quality of life, and physiological function in patients with long COVID. The findings will help inform the design of future controlled trials evaluating non-invasive neuromodulation strategies for persistent neurological and fatigue-related symptoms after COVID-19.
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
盲法说明
No masking will be used. This is a single-arm open-label study without a sham or control group.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 18 and 70 years.
- •Diagnosis of long COVID according to World Health Organization criteria, defined as symptoms persisting for at least three months after acute SARS-CoV-2 infection and lasting for a minimum of two months without an alternative explanation.
- •Presence of persistent fatigue and/or cognitive impairment, commonly described as brain fog, attributed to long COVID and confirmed at screening.
- •Stable clinical condition allowing participation in the intervention and assessment procedures.
- •Ability to understand the study procedures and provide written informed consent.
排除标准
- •Contraindications to transcranial direct current stimulation, including the presence of implanted electronic devices such as pacemakers or neurostimulators, intracranial metallic implants, or history of epilepsy or seizures.
- •History of neurological disorders that may affect cognitive function, including stroke, Parkinson's disease, or neurodegenerative disorders.
- •Pre-existing conditions associated with chronic fatigue or cognitive impairment prior to SARS-CoV-2 infection, such as fibromyalgia, chronic fatigue syndrome, or multiple sclerosis.
- •Severe psychiatric disorders, including psychosis or severe depression.
- •Substance abuse, including alcohol or drugs.
- •Current oncological treatment with chemotherapy or radiotherapy.
- •Pregnancy.
- •Any medical condition that, in the opinion of the investigators, may interfere with participation or with the interpretation of the results.
研究组 & 干预措施
tDCS Intervention
Participants will receive 30 sessions of transcranial direct current stimulation applied over the left dorsolateral prefrontal cortex. Stimulation will be delivered at 2 mA for 20 minutes per session, once daily, five days per week, under supervision of trained healthcare professionals.
干预措施: Transcranial Direct Current Stimulation (Device)
结局指标
主要结局
Change in Health-Related Quality of Life
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the Short Form-36 Health Survey (SF-36). Changes from baseline to post-intervention will be evaluated.
Change in Fatigue Severity
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Fatigue severity and its impact on daily functioning will be assessed using the Modified Fatigue Impact Scale (MFIS). Changes from baseline to post-intervention will be evaluated.
Change in Cognitive Function
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Cognitive function will be assessed using a neuropsychological test battery including the Montreal Cognitive Assessment (MoCA), verbal fluency tasks, and the Stroop test. Changes from baseline to post-intervention will be evaluated.
Change in EuroQol 5-Dimension 5-Level Questionnaire Score
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated across five levels of severity. Higher scores or index values reflect better health status, depending on the scoring method used. Changes from baseline to post-intervention will be evaluated.
Change in Modified Fatigue Impact Scale Score
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS). The MFIS assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. The total score ranges from 0 to 84, with higher scores indicating greater fatigue impact. Changes from baseline to post-intervention will be evaluated.
Change in Montreal Cognitive Assessment Score
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Global cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA evaluates cognitive domains including attention, memory, language, visuospatial abilities, executive function, abstraction, calculation, and orientation. The total score ranges from 0 to 30, with higher scores indicating better cognitive performance. Changes from baseline to post-intervention will be evaluated.
Change in Short Form-36 Health Survey Score
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Health-related quality of life will be assessed using the Short Form-36 Health Survey (SF-36). The SF-36 evaluates eight domains of health-related quality of life: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, and general health. Scores are transformed to a 0-100 scale, with higher scores indicating better health-related quality of life. Changes from baseline to post-intervention will be evaluated.
Change in Verbal Fluency Task Performance
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Verbal fluency will be assessed using verbal fluency tasks. Performance will be evaluated based on the number of correct words generated within the specified time period. Higher scores indicate better verbal fluency performance. Changes from baseline to post-intervention will be evaluated.
Change in Stroop Test Performance
时间窗: Baseline and 3 days after completion of the 30-session tDCS intervention
Executive function, inhibitory control, and cognitive flexibility will be assessed using the Stroop test. Performance will be evaluated using test-specific measures such as response accuracy and/or completion time. Better performance is reflected by higher accuracy and/or shorter completion time, depending on the scoring method used. Changes from baseline to post-intervention will be evaluated.
次要结局
- Change in Brain Metabolism(Baseline and 3 days after completion of the 30-session tDCS intervention)
- Change in Heart Rate Variability(Baseline and 3 days after completion of the 30-session tDCS intervention)
- Change in Endurance Capacity(Baseline and 3 days after completion of the 30-session tDCS intervention)
- Change in Handgrip Strength(Baseline and 3 days after completion of the 30-session tDCS intervention)
- Change in Lower-Limb Neuromuscular Performance(Baseline and 3 days after completion of the 30-session tDCS intervention)
- Intervention Tolerability and Adverse Effects(During each tDCS session throughout the 30-session intervention period)
- Tolerability of the tDCS Intervention(During each tDCS session throughout the 30-session intervention period)
- Adverse Effects Related to tDCS(During each tDCS session throughout the 30-session intervention period)
研究者
David Morales Álamo
Associate Professor
University of Las Palmas de Gran Canaria