COVID-19STIMULATECOVIDNCT05252481
Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
A study testing Active tDCS in people with COVID-19, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
Fatigue is common and disabling in patients with post-COVID syndrome. There is no treatment available at this moment, and fatigue has important consequences. The main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-COVID condition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Active tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2022to 31 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COVID-19 with PCR-confirmation.
- Fatigue linked to COVID-19
- No diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue.
Who cannot join
- Stroke before COVID-19
- History of traumatic brain lesion or central nervous system infection previous to COVID-19
- Radiotherapy or chemotherapy for cancer
- Severe sensorial deficits
- Drugs or uncontrolled medical disorder with potential impact on fatigue.
- History of abuse of alcohol or other toxics.
- Any contraindication for tDCS (metallic implants, brain devices, pacemakers, head injuries).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
Fatigue is common and disabling in patients with post-COVID syndrome. There is no treatment available at this moment, and fatigue has important consequences. The main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-COVID condition. This is a randomized, parallel, double-blind, placebo-controlled clinical trial using transcranial direct current stimulation. Secondary aims include changes in cognition, depression, and quality of life.
- Conditions
- COVID-19
- Being tested
- Active tDCS, Sham tDCS
- Keywords
- Post-COVID-19 syndrome, Post-COVID-19 condition, Persistent COVID-19, Long-Haul COVID-19, Fatigue
- Medical subject headings
- COVID-19, 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.
Active tDCSDevice
Eight sessions of transcranial current direct stimulation
Sham tDCSDevice
Eight sessions of transcranial current direct stimulation (sham)
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Active comparator | Transcranial current direct stimulation. 8 days. Receives: Device: Active tDCS |
| Sham tDCS | Sham comparator | Sham transcranial current direct stimulation. 8 days. Receives: Device: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fatigue
Modified Fatigue Impact Scale (MFIS)
Measured: 2 weeks
Secondary outcomes (3)
Change in cognition
Stroop Test
Measured: 2 weeks
Change in depressive symptoms
Beck Depression Inventory II
Measured: 2 weeks
Change in quality of life
EuroQuol-5D
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start1 Apr 2022
- Primary completion26 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jordi A Matias-Guiu, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252481
- Sponsor's protocol ID
- 22-120
- Acronym
- STIMULATECOVID
- Status last verified
- Aug 2022
- First submitted
- 19 Feb 2022
- Last updated
- 22 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
- ClinicalTrials.gov ID
- NCT05252481
- Acronym / sponsor ID
- STIMULATECOVID / 22-120
- Conditions
- COVID-19
- Keywords
- Post-COVID-19 syndrome, Post-COVID-19 condition, Persistent COVID-19, Long-Haul COVID-19, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 26 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 23 Feb 2022 (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.
Fatigue is common and disabling in patients with post-COVID syndrome. There is no treatment available at this moment, and fatigue has important consequences. The main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-COVID condition. This is a randomized, parallel, double-blind, placebo-controlled clinical trial using transcranial direct current stimulation. Secondary aims include changes in cognition, depression, and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Active comparator | Device: Active tDCSTranscranial current direct stimulation. 8 days. |
| Sham tDCS | Sham comparator | Device: Sham tDCSSham transcranial current direct stimulation. 8 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of COVID-19 with PCR-confirmation.
- Fatigue linked to COVID-19
- No diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue.
Key exclusion criteria (7 listed)
- Stroke before COVID-19
- History of traumatic brain lesion or central nervous system infection previous to COVID-19
- Radiotherapy or chemotherapy for cancer
- Severe sensorial deficits
- Drugs or uncontrolled medical disorder with potential impact on fatigue.
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 |
|---|---|---|
| Active tDCSEight sessions of transcranial current direct stimulation | Device | Active tDCS |
| Sham tDCSEight sessions of transcranial current direct stimulation (sham) | Device | Sham tDCS |
Primary outcome
Change in Fatigue
Time frame: 2 weeks
Modified Fatigue Impact Scale (MFIS)
3 secondary outcomes
Change in cognition
Time frame: 2 weeks
Change in depressive symptoms
Time frame: 2 weeks
Change in quality of life
Time frame: 2 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 22 Aug 2022.
- Individual participant dataSharing planned: No
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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 Active tDCS in people with COVID-19, run by Hospital San Carlos, Madrid 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 3 inclusion and 7 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 22 Aug 2022. 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. Some participants in this study may receive a placebo. 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 (time frame: 2 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 22 Aug 2022; AzTrials last refreshed its copy on 6 Nov 2026.