An interventional study of Transcranial Direct Current Stimulation in Long COVID Fatigue, Brain Fog and Chronic Pain, sponsored by Hospital de Basurto. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Hospital de Basurto · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if home-based transcranial direct current stimulation (tDCS) works to treat fatigue and other symptoms in adults with Long COVID. It will also learn about the safety and home adherence of this intervention. The main questions it aims to answer are:
Does active tDCS lower fatigue severity (FAS score) compared to sham treatment?
What are the effects of the treatment sequence on cognition, pain, anxiety, depression, and quality of life?
Researchers will compare a sequence of active tDCS followed by sham tDCS to a sequence of sham tDCS followed by active tDCS in a crossover design to see if the intervention works.
Participants will:
Receive a tapered schedule of home-based tDCS over 3 weeks per intervention period (totaling 42 sessions per intervention, separated by a 4-week washout period)
Complete symptom evaluations and cognitive/clinical tests at baseline, after Phase 1, and after Phase 2
Log their daily sessions to track home adherence and report any potential side effects
This is a randomized, double-blind, sham-controlled, crossover clinical trial designed to evaluate the efficacy, safety, and adherence of a home-based transcranial direct current stimulation (tDCS) program for adults suffering from Long COVID.
Background and Rationale:
Long COVID is characterized by persistent, debilitating symptoms following acute SARS-CoV-2 infection, with fatigue, cognitive dysfunction ("brain fog"), pain, anxiety, and depression being among the most prevalent and disabling manifestations. Non-invasive brain stimulation, specifically tDCS targeting prefrontal regions implicated in cognitive and affective regulation, represents a promising neuromodulatory therapeutic approach. This trial investigates whether a home-based tDCS protocol can be safely and effectively administered in a real-world setting to improve clinical outcomes.
Study Design and Intervention:
A total of 40 eligible participants are randomized in a 1:1 ratio into one of two treatment sequences:
Each treatment period utilizes a 3-week tapered schedule comprising a total of 42 sessions per intervention:
Assessments and Safety:
Participants undergo rigorous clinical evaluations at baseline, at the end of Phase 1 (following 42 sessions), and at the end of Phase 2 (following crossover and completion of the second 42 sessions). The primary outcome is fatigue severity assessed via the Fatigue Assessment Scale (FAS). Secondary outcomes include cognitive performance (MoCA), pain intensity (VAS), anxiety and depression symptoms (HADS-A and HADS-D), and health-related quality of life (PROMIS-G10). Home adherence rates and side effect profiles are prospectively monitored throughout the protocol to evaluate the real-world scalability and safety of unsupervised, home-based tDCS administration.
159 studies on the registry are indexed under Mental Fatigue; 55 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 129 interventional studies indexed under Mental Fatigue.
Browse Mental Fatigue studies →Hospital de Basurto is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Participants were recruited from the specialised Long COVID Unit at Basurto University Hospital (Bilbao, Spain)
Inclusion Criteria:
Exclusion Criteria:
Exclusion criteria included age younger than 18 years or older than 65, pregnancy, recent initiation or modification of antidepressant or analgesic treatments within the previous month, major neurological or systemic disorders potentially explaining the symptoms, active substance abuse, and contraindications to tDCS such as metallic cranial implants, cochlear implants, ventricular shunts, or cardiac pacemakers. Patients unable to correctly self-administer the intervention at home were also excluded.
Participants receive sham tDCS during Period 1 (42 sessions over 3 weeks), followed by a 4-week washout period, and then active tDCS during Period 2 (42 sessions over 3 weeks).
Device: Transcranial Direct Current Stimulation
Participants receive active tDCS during Period 1 (42 sessions over 3 weeks), followed by a 4-week washout period, and then sham tDCS during Period 2 (42 sessions over 3 weeks).
Device: Transcranial Direct Current Stimulation
The intervention utilizes a home-based transcranial direct current stimulation (tDCS) protocol administered autonomously by participants in real-world settings.Transcranial direct current stimulation (tDCS) delivers low-intensity direct electrical current through scalp electrodes in order to modulate cortical excitability and synaptic plasticity. The treatment plan features a specific 3-week tapered schedule per intervention period totaling 42 sessions: Week 1 consists of 3 sessions per day (morning, afternoon, and evening; 21 sessions), Week 2 consists of 2 sessions per day (morning and afternoon; 14 sessions), and Week 3 consists of 1 session per day (any time of day; 7 sessions).
Change in fatigue severity measured by the Fatigue Assessment Scale (FAS)
Total score ranges from 10 to 50, with higher scores indicating greater fatigue severity.
Time frame: From enrollment to the end of treatment at 14 weeks
Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
Subscale score ranges from 0 to 21, with higher scores indicating greater symptom severity
Time frame: From enrollment to the end of treatment at 14 weeks
Change in self-reported pain intensity measured by the Visual Analogue Scale (VAS)
Score ranges from 0 (no pain) to 10 (worst possible pain).
Time frame: From enrollment to the end of treatment at 14 weeks
Change in cognitive function measured by the Montreal Cognitive Assessment (MoCA)
Cognition evaluation, using Montreal Cognitive Assessment \[MoCA\] test
Time frame: From enrollment to the end of treatment at 14 weeks
Change in health-related quality of life measured by the PROMIS Global Health 10 questionnaire
Change in health-related quality of life measured by the PROMIS Global Health 10 questionnaire
Time frame: From enrollment to the end of treatment at 14 weeks
Plan to share: No — Individual participant data will not be publicly shared to protect participant privacy and maintain confidentiality in accordance with European (GDPR) and national data protection regulations and the approved ethics protocol.
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Jan 2026, 4 months.
Of 74 non-industry interventional studies with no phase under Mental Fatigue, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's 4 months is below that.
Counting every sponsor, half of 87 studies reached it within 7 months; a quarter within 3 and three quarters within 22.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Hospital de Basurto