Long COVID FatigueNCT07880171
Intensive Home-based Transcranial Direct Current Stimulation for Long COVID
A study testing Transcranial Direct Current Stimulation in people with Long COVID Fatigue and Brain Fog, run by Hospital de Basurto at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Long COVID Fatigue, Brain Fog, Chronic Pain
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2025to 29 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Met the World Health Organization clinical case definition for post-COVID-19 condition
- Suffered severe fatigue (Fatigue Assessment Scale [FAS] score ≥42).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitario Basurto - Osakidetza / Basurto University Hospital - Basque Health System
Bilbao, Bizkaia, 48013
About this study
Official title: Intensive Home-based Transcranial Direct Current Stimulation for Long COVID: a Randomised, Double-blind, Sham-controlled, Crossover Pilot Trial
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?
Read more
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
Read the detailed description
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:
- Sequence 1: Sham tDCS during Period 1, followed by a 4-week washout period, and active tDCS during Period 2.
- Sequence 2: Active tDCS during Period 1, followed by a 4-week washout period, and sham tDCS during Period 2.
Each treatment period utilizes a 3-week tapered schedule comprising a total of 42 sessions per intervention:
- Week 1: 3 sessions per day (morning, afternoon, evening; 21 sessions total).
- Week 2: 2 sessions per day (morning, afternoon; 14 sessions total).
- Week 3: 1 session per day (any time of day; 7 sessions total).
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.
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Long COVID, Transcranial direct current stimulation, tDCS, Fatigue, Post COVID19 condition, Non-invasive brain stimulation, Neuromodulation, Homa-based therapy
- Medical subject headings
- Mental Fatigue, Chronic Pain, Post-Acute COVID-19 Syndrome, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: Sham to Active | Experimental | 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). Receives: Device: Transcranial Direct Current Stimulation |
| Sequence 2: Active to shame | Experimental | 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). Receives: Device: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 14 weeks
Secondary outcomes (4)
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
Measured: 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).
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start2 Sep 2025
- Primary completion25 Jan 2026
- Study completion29 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVID FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind, crossover trial where participants are allocated in a 1:1 ratio to one of two sequences. Sequence 1 receives sham tDCS in Period 1 followed by active tDCS in Period 2. Sequence 2 receives active tDCS in Period 1 followed by sham tDCS in Period 2. A 4-week washout period separates the two treatment phases to prevent carryover effects.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Basurto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markel Erburu, Hospital de Basurto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880171
- Sponsor's protocol ID
- PS2025037
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Home-based Transcranial Direct Current Stimulation for Long COVID: a Randomised, Double-blind, Sham-controlled, Crossover Pilot Trial
- ClinicalTrials.gov ID
- NCT07880171
- Acronym / sponsor ID
- PS2025037
- Keywords
- Long COVID, Transcranial direct current stimulation, tDCS, Fatigue, Post COVID19 condition, Non-invasive brain stimulation, Neuromodulation, Homa-based therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital de BasurtoUniversity, hospital or other
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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:
- Sequence 1: Sham tDCS during Period 1, followed by a 4-week washout period, and active tDCS during Period 2.
- Sequence 2: Active tDCS during Period 1, followed by a 4-week washout period, and sham tDCS during Period 2.
Each treatment period utilizes a 3-week tapered schedule comprising a total of 42 sessions per intervention:
- Week 1: 3 sessions per day (morning, afternoon, evening; 21 sessions total).
- Week 2: 2 sessions per day (morning, afternoon; 14 sessions total).
- Week 3: 1 session per day (any time of day; 7 sessions total).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, crossover trial where participants are allocated in a 1:1 ratio to one of two sequences. Sequence 1 receives sham tDCS in Period 1 followed by active tDCS in Period 2. Sequence 2 receives active tDCS in Period 1 followed by sham tDCS in Period 2. A 4-week washout period separates the two treatment phases to prevent carryover effects.
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: Sham to Active | Experimental | Device: Transcranial Direct Current StimulationParticipants 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). |
| Sequence 2: Active to shame | Experimental | Device: Transcranial Direct Current StimulationParticipants 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Met the World Health Organization clinical case definition for post-COVID-19 condition
- Suffered severe fatigue (Fatigue Assessment Scale [FAS] score ≥42).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current StimulationThe 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). | Device | Sequence 1: Sham to Active, Sequence 2: Active to shame |
Primary outcome
Change in fatigue severity measured by the Fatigue Assessment Scale (FAS)
Time frame: From enrollment to the end of treatment at 14 weeks
Total score ranges from 10 to 50, with higher scores indicating greater fatigue severity.
4 secondary outcomes
Change in depressive symptoms measured by the Hospital Anxiety and Depression Scale (HADS-D)
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)
Time frame: From enrollment to the end of treatment at 14 weeks
Change in cognitive function measured by the Montreal Cognitive Assessment (MoCA)
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
Time frame: From enrollment to the end of treatment at 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Direct Current Stimulation in people with Long COVID Fatigue and Brain Fog, run by Hospital de Basurto at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue severity measured by the Fatigue Assessment Scale (FAS) (time frame: From enrollment to the end of treatment at 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.