COVID-19NCT05753202
tDCS in Post-COVID Syndrome: Comparison of Two Targets
A study testing transcranial current direct stimulation in people with COVID-19 and Post-COVID-19 Syndrome, run by Hospital San Carlos, Madrid at 1 site in Spain.
Trial summary
The main aim of this study is to compare the effect of two non-invasive neuromodulation targets in patients meeting WHO criteria for the post-COVID condition. A randomized, parallel, double-blind study will be conducted. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19, Post-COVID-19 Syndrome, Post COVID-19 Condition
- What is being tested?
- transcranial current direct 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
- 1 Mar 2023to 30 Jun 2024
- 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
- Confirmed diagnosis of COVID-19 at least 6 months before the participation in the study.
- Diagnosis of post-COVID condition according to WHO criteria.
- Age 18-65 years.
- Spanish as native language.
- Sign of written informed consent.
Who cannot join
- History of stroke
- History of traumatic brain injury or central nervous system infection
- Diagnosis of other neurological or medical disorder that could impact on fatigue.
- Diagnosis of active psychiatric disorder potentially impacting on fatigue or cognitive function.
- Chemotherapy or radiotherapy for cancer.
- Severe sensory deficits (e.g. visual loss) that could limit assessments included int the study protocol.
Show all 9Show fewer
- Taking drugs or uncontrolled medical disorder potentially causing or worsening fatigue. Specifically, uncontrolled adrenal insufficiency, miastenic syndromes, thyroid disorders, cardiac failure, chronic kidney disorders and neurodegenerative disorders are excluded.
- History of abuse of alcohol or other toxics.
- Any contraindication for transcranial electric stimulation: epilepsy, pregnancy, metallic implants, brain devices, pacemakers, head injuries).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation Using Transcranial Direct Current Stimulation (tDCS) in Post-COVID Syndrome: Comparison of Two Targets
The main aim of this study is to compare the effect of two non-invasive neuromodulation targets in patients meeting WHO criteria for the post-COVID condition. A randomized, parallel, double-blind study will be conducted. Patients will receive 15 neuromodulation sessions through transcranial electrical stimulation for 3 weeks, associated with cognitive stimulation during therapy. The main objective will be to evaluate the change in physical fatigue. As secondary objectives, changes in cognition, depression, pain, quality of sleep and quality of life will be evaluated. The objective of this study is to evaluate the effect of two targets (left dorsolateral prefrontal and M1) of the neuromodulation intervention, together with cognitive stimulation.
- Conditions
- COVID-19, Post-COVID-19 Syndrome, Post COVID-19 Condition
- Being tested
- transcranial current direct stimulation
- Keywords
- post-COVID syndrome, brain stimulation, fatigue, cognitive, depression, transcranial direct current stimulation, non-invasive brain stimulation
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial current direct stimulationDevice
Transcranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week)
| Study group | Role | What they receive |
|---|---|---|
| Left dorsolateral prefrontal cortex | Active comparator | 15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training. Receives: Device: transcranial current direct stimulation |
| Left M1 | Active comparator | 15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training. Receives: Device: transcranial current direct stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Severity Scale (score)
Physical fatigue
Measured: 1 month
Secondary outcomes (5)
Modified Fatigue Impact Scale (MFIS) (score)
Physical and cognitive fatigue
Measured: 1 month
FLEI scale (score)
Subjective cognition.
Measured: 1 month
Beck Depression Inventory (2nd version) (score)
Depressive symptoms
Measured: 1 month
Pittsburgh Sleep Quality Index (score)
Sleep quality
Measured: 1 month
Brief Pain Inventory (score)
Pain
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 40 participants (estimated)
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
- Investigators
- Jordi A Matias-Guiu, PhD, Principal investigator, Hospital Clinico San Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753202
- Sponsor's protocol ID
- 22/728-P-EC
- Status last verified
- Jan 2024
- First submitted
- 1 Mar 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Oliver-Mas S, Matias-Guiu JA, Delgado-Alonso C, Gil-Martinez L, Cuevas C, Polidura C, Fernandez-Romero L, Matias-Guiu A, Gomez-Ruiz N, Gil-Moreno MJ, Yus-Fuertes M, Matias-Guiu J, Diez-Cirarda M. A randomized comparative feasibility study of neuromodulation and cognitive training for post-COVID fatigue. Sci Rep. 2025 Jul 23;15(1):26818. doi: 10.1038/s41598-025-09772-8.
PubMed 40702022
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Using Transcranial Direct Current Stimulation (tDCS) in Post-COVID Syndrome: Comparison of Two Targets
- ClinicalTrials.gov ID
- NCT05753202
- Acronym / sponsor ID
- 22/728-P-EC
- Conditions
- COVID-19, Post-COVID-19 Syndrome, Post COVID-19 Condition
- Keywords
- post-COVID syndrome, brain stimulation, fatigue, cognitive, depression, transcranial direct current stimulation, non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Mar 2023 (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 main aim of this study is to compare the effect of two non-invasive neuromodulation targets in patients meeting WHO criteria for the post-COVID condition. A randomized, parallel, double-blind study will be conducted. Patients will receive 15 neuromodulation sessions through transcranial electrical stimulation for 3 weeks, associated with cognitive stimulation during therapy. The main objective will be to evaluate the change in physical fatigue. As secondary objectives, changes in cognition, depression, pain, quality of sleep and quality of life will be evaluated. The objective of this study is to evaluate the effect of two targets (left dorsolateral prefrontal and M1) of the neuromodulation intervention, together with cognitive stimulation.
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 |
|---|---|---|
| Left dorsolateral prefrontal cortex | Active comparator | Device: transcranial current direct stimulation15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training. |
| Left M1 | Active comparator | Device: transcranial current direct stimulation15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of COVID-19 at least 6 months before the participation in the study.
- Diagnosis of post-COVID condition according to WHO criteria.
- Age 18-65 years.
- Spanish as native language.
- Sign of written informed consent.
Key exclusion criteria (9 listed)
- History of stroke
- History of traumatic brain injury or central nervous system infection
- Diagnosis of other neurological or medical disorder that could impact on fatigue.
- Diagnosis of active psychiatric disorder potentially impacting on fatigue or cognitive function.
- Chemotherapy or radiotherapy for cancer.
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 current direct stimulationTranscranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week) | Device | Left M1, Left dorsolateral prefrontal cortex |
Primary outcome
Fatigue Severity Scale (score)
Time frame: 1 month
Physical fatigue
5 secondary outcomes
Modified Fatigue Impact Scale (MFIS) (score)
Time frame: 1 month
FLEI scale (score)
Time frame: 1 month
Beck Depression Inventory (2nd version) (score)
Time frame: 1 month
Pittsburgh Sleep Quality Index (score)
Time frame: 1 month
Brief Pain Inventory (score)
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Derived from this study: PubMed 40702022Oliver-Mas S, Matias-Guiu JA, Delgado-Alonso C, Gil-Martinez L, Cuevas C, Polidura C, Fernandez-Romero L, Matias-Guiu A, Gomez-Ruiz N, Gil-Moreno MJ, Yus-Fuertes M, Matias-Guiu J, Diez-Cirarda M. A randomized comparative feasibility study of neuromodulation and cognitive training for post-COVID fatigue. Sci Rep. 2025 Jul 23;15(1):26818. doi: 10.1038/s41598-025-09772-8.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Jordi A Matias-Guiu, PhD principal investigator
Hospital Clinico San Carlos
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 current direct stimulation in people with COVID-19 and Post-COVID-19 Syndrome, 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 30 Jan 2024. 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?
Results are not available in the source record.
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?
Fatigue Severity Scale (score) (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753202, which also lists 1 linked publication.
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 30 Jan 2024.