Transcranial Direct Current Stimulation for Long COVID Brain Fog and Fatigue
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Las Palmas de Gran Canaria
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Direct Current Stimulation
DeviceTranscranial direct current stimulation will be delivered using a constant-current stimulator through surface electrodes placed over the scalp. The anode will be positioned over the left dorsolateral prefrontal cortex, corresponding to F3 according to the international 10-20 EEG system, and the cathode will be placed over the contralateral supraorbital region. Each session will be delivered at 2 mA for 20 minutes. Participants will complete 30 sessions.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: tDCS InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in EuroQol 5-Dimension 5-Level Questionnaire Score
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.
Time frame
Baseline and 3 days after completion of the 30-session tDCS intervention2
Change in Modified Fatigue Impact Scale Score
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.
Time frame
Baseline and 3 days after completion of the 30-session tDCS intervention3
Change in Montreal Cognitive Assessment Score
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.
Time frame
Baseline and 3 days after completion of the 30-session tDCS intervention4
Change in Short Form-36 Health Survey Score
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.
Time frame
Baseline and 3 days after completion of the 30-session tDCS interventionSecondary outcomes
1
Change in Brain Metabolism
Brain metabolism will be assessed using positron emission tomography-computed tomography (PET-CT). Changes from baseline to post-intervention will be evaluated.
Time frame
Baseline and 3 days after completion of the 30-session tDCS intervention2
Change in Heart Rate Variability
Autonomic nervous system activity will be assessed using heart rate variability (HRV) recorded under resting conditions. Time-domain, frequency-domain, and non-linear HRV indices will be evaluated to characterize changes in autonomic regulation.
Time frame
Baseline and 3 days after completion of the 30-session tDCS intervention3
Change in Endurance Capacity
Endurance capacity will be assessed using the Ekblom-Bak submaximal cycle ergometer test. Heart rate responses, perceived exertion, estimated maximal oxygen uptake, and internal load will be evaluated under standardized conditions.
Time frame
Baseline and 3 days after completion of the 30-session tDCS intervention4
Change in Handgrip Strength
Upper-limb muscle strength will be assessed using handgrip dynamometry. Participants will perform three maximal attempts, and the highest value will be used for analysis.
Time frame
Baseline and 3 days after completion of the 30-session tDCS interventionLocations
Sponsors and contacts
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University of Las Palmas de Gran Canaria
Lead sponsor
Fundación Canaria Instituto de Investigación Sanitaria de Canarias
Collaborator
Canary Islands Health Service
Collaborator
Source ClinicalTrials.gov
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