Post Covid-19 PatientsNCT04876417
Transcranial Direct Current Stimulation (tDCS) for Post COVID-19 Fatigue
A study testing Transcranial Direct Current Stimulation in people with Post Covid-19 Patients, run by University of Iowa at 1 site in United States.
Trial summary
The objective of this study is to investigate the short- and long-term effects of multiple sessions of 4 mA M1 tDCS on fatigue and brain activity in recovered COVID-19 patients using established measures of perception of fatigue, performance fatigability, and cerebral glucose uptake. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Post Covid-19 Patients
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 yrs.
- Meet CDC guidelines (https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html) for discontinuation of home isolation
- Meet the criteria for fatigue, based on the Chalder Fatigue Scale CFQ-11 case definition of fatigue
- Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history, such as cardiovascular disease.
- Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form.
- Able to use and be contacted by telephone
- Able to speak, read, and understand English, and complete questionnaires in English
Who cannot join
- Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), or neurological disorders
- History/presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
- Alcohol dependence or abuse (>2 drinks/day), or present history of drug abuse (last six months)
- History of significant traumatic brain injury or hydrocephalus
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Health and Human Physiology
Iowa City, Iowa, 52242
About this study
Official title: Transcranial Direct Current Stimulation (tDCS) for the Treatment of Fatigue in Post-COVID-19 Patients
The objective of this study is to investigate the short- and long-term effects of multiple sessions of 4 mA M1 tDCS on fatigue and brain activity in recovered COVID-19 patients using established measures of perception of fatigue, performance fatigability, and cerebral glucose uptake. Our central hypothesis is that tDCS will improve fatigue short- and long-term, and thus will improve quality of life (QOL) in recovered COVID-19 patients and that these changes will be associated with alterations in brain activity.
Read the detailed description
For survivors of severe COVID-19, overcoming the virus is just the beginning of an uncharted recovery path. As the number of confirmed COVID-19 cases exceeds 27 million globally and 6 million in the US, the number of patients who experience persistent symptoms during recovery is rapidly growing. In COVID-19 patients, common acute symptoms include cough, fever, dyspnea, musculoskeletal symptoms (myalgia, joint pain, fatigue), gastrointestinal symptoms, and anosmia/dysgeusia . Clinicians and researchers have focused on the acute phase of COVID-19, but continued monitoring and treating of persistent symptoms is urgently needed. Recent studies assessed persistent symptoms in patients who were discharged from the hospital after recovering from COVID-19. None of the patients had a fever or any of the other signs or symptoms associated with acute illness. Nevertheless, decreased quality of life was observed in 44.1% and fatigue was reported by 53.1% and 71% of patients. Furthermore, persistent fatigue following COVID-19 infection is common and independent of severity of initial infection (hospitalized and non-hospitalized patients). In addition to the characteristic laboratory findings and lung computed tomography (CT) abnormalities, it has been recently reported that patients with COVID-19 also have neurological manifestations. Wu et al. [2020] found that viral infections have detrimental impacts on neurological functions and can even cause severe neurological damage. Their study showed that coronaviruses (CoV), especially severe acute respiratory syndrome CoV 2 (SARS-CoV-2), exhibited neurotropic properties and may cause neurological diseases with severe fatigue symptoms. Another recent case report has also indicated reduced glucose uptake ([18F]flurodeoxyglucose (FDG); measured with positron emission tomography (PET)) in diverse brain areas [9], which may contribute to these neurological manifestations. Therefore, there is a critical need to develop inexpensive, effective, and rapid treatments for the persistent fatigue experienced by recovered COVID-19 patients. Without such treatments, these patients will continue to experience fatiguing symptoms that significantly reduce their quality of life. One possible treatment modality is transcranial direct current stimulation (tDCS) [10]. tDCS uses weak currents applied to the scalp to alter the excitability of cortical neurons by changing their spontaneous firing rate. It also has a favorable safety profile and only transient adverse side effects. Studies in patients with neurological disorders have shown that tDCS over the primary motor and/or sensory cortex (M1/S1) consistently and significantly improves fatigue. M1 tDCS represents an easy, cost-effective candidate for treating persistent fatigue in recovered COVID-19 patients.
- Conditions
- Post Covid-19 Patients
- Being tested
- Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Keywords
- Covid-19, Fatigue
- Medical subject headings
- COVID-19, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Also called tDCS
Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
Sham Transcranial Direct Current StimulationDevice
Also called tDCS
Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
| Study group | Role | What they receive |
|---|---|---|
| tDCS and fatigue | Active comparator | This group will receive the active form of tDCS. Receives: Device: Transcranial Direct Current Stimulation |
| Sham and fatigue | Sham comparator | This group will receive the sham form of tDCS. Receives: Device: Sham Transcranial Direct Current Stimulation |
| tDCS and non-fatigue | Active comparator | This group will receive the active form of tDCS. Receives: Device: Transcranial Direct Current Stimulation |
| Sham and non-fatigue | Sham comparator | This group will receive the sham form of tDCS. Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Assessment Scale (FAS)
Fatigue Questionnaire (1 to 5-point scale x 10 questions for a total score range of 0 to 50) where a low value indicates less fatigued (better outcome) and a high value indicates more fatigued (worse outcome)
Measured: through study completion, an average of 8 weeks
Fatigue Severity Scale (FSS)
Fatigue Questionnaire (1 to 7 point scale x 9 questions for a total score range of 0 to 63) with a low value indicating less severe fatigue (better outcome) and a high value indicating more severe fatigue (worse outcome)
Measured: through study completion, an average of 8 weeks
6-minute Walk Test
Distance in meters will be measured in six minutes
Measured: through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start15 Jun 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Covid-19 PatientsStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04876417
- Sponsor's protocol ID
- 202009381
- Status last verified
- Apr 2024
- First submitted
- 15 Mar 2021
- Last updated
- 1 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Direct Current Stimulation (tDCS) for the Treatment of Fatigue in Post-COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04876417
- Acronym / sponsor ID
- 202009381
- Conditions
- Post Covid-19 Patients
- Keywords
- Covid-19, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 6 May 2021 (actual)
- Results
- Posted 1 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the short- and long-term effects of multiple sessions of 4 mA M1 tDCS on fatigue and brain activity in recovered COVID-19 patients using established measures of perception of fatigue, performance fatigability, and cerebral glucose uptake. Our central hypothesis is that tDCS will improve fatigue short- and long-term, and thus will improve quality of life (QOL) in recovered COVID-19 patients and that these changes will be associated with alterations in brain activity.
Detailed description
For survivors of severe COVID-19, overcoming the virus is just the beginning of an uncharted recovery path. As the number of confirmed COVID-19 cases exceeds 27 million globally and 6 million in the US, the number of patients who experience persistent symptoms during recovery is rapidly growing. In COVID-19 patients, common acute symptoms include cough, fever, dyspnea, musculoskeletal symptoms (myalgia, joint pain, fatigue), gastrointestinal symptoms, and anosmia/dysgeusia . Clinicians and researchers have focused on the acute phase of COVID-19, but continued monitoring and treating of persistent symptoms is urgently needed. Recent studies assessed persistent symptoms in patients who were discharged from the hospital after recovering from COVID-19. None of the patients had a fever or any of the other signs or symptoms associated with acute illness. Nevertheless, decreased quality of life was observed in 44.1% and fatigue was reported by 53.1% and 71% of patients. Furthermore, persistent fatigue following COVID-19 infection is common and independent of severity of initial infection (hospitalized and non-hospitalized patients). In addition to the characteristic laboratory findings and lung computed tomography (CT) abnormalities, it has been recently reported that patients with COVID-19 also have neurological manifestations. Wu et al. [2020] found that viral infections have detrimental impacts on neurological functions and can even cause severe neurological damage. Their study showed that coronaviruses (CoV), especially severe acute respiratory syndrome CoV 2 (SARS-CoV-2), exhibited neurotropic properties and may cause neurological diseases with severe fatigue symptoms. Another recent case report has also indicated reduced glucose uptake ([18F]flurodeoxyglucose (FDG); measured with positron emission tomography (PET)) in diverse brain areas [9], which may contribute to these neurological manifestations. Therefore, there is a critical need to develop inexpensive, effective, and rapid treatments for the persistent fatigue experienced by recovered COVID-19 patients. Without such treatments, these patients will continue to experience fatiguing symptoms that significantly reduce their quality of life. One possible treatment modality is transcranial direct current stimulation (tDCS) [10]. tDCS uses weak currents applied to the scalp to alter the excitability of cortical neurons by changing their spontaneous firing rate. It also has a favorable safety profile and only transient adverse side effects. Studies in patients with neurological disorders have shown that tDCS over the primary motor and/or sensory cortex (M1/S1) consistently and significantly improves fatigue. M1 tDCS represents an easy, cost-effective candidate for treating persistent fatigue in recovered COVID-19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| tDCS and fatigue | Active comparator | Device: Transcranial Direct Current StimulationThis group will receive the active form of tDCS. |
| Sham and fatigue | Sham comparator | Device: Sham Transcranial Direct Current StimulationThis group will receive the sham form of tDCS. |
| tDCS and non-fatigue | Active comparator | Device: Transcranial Direct Current StimulationThis group will receive the active form of tDCS. |
| Sham and non-fatigue | Sham comparator | Device: Sham Transcranial Direct Current StimulationThis group will receive the sham form of tDCS. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-80 yrs.
- Meet CDC guidelines (https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html) for discontinuation of home isolation
- Meet the criteria for fatigue, based on the Chalder Fatigue Scale CFQ-11 case definition of fatigue
- Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history, such as cardiovascular disease.
- Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form.
Key exclusion criteria (5 listed)
- Medical diagnosis or condition that is considered to be an absolute or relative contraindication to participating in exercise training, such as major renal, pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal cell cancer), or neurological disorders
- History/presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
- Alcohol dependence or abuse (>2 drinks/day), or present history of drug abuse (last six months)
- History of significant traumatic brain injury or hydrocephalus
- Pregnancy
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 StimulationAlso: tDCSTranscranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability. | Device | tDCS and fatigue, tDCS and non-fatigue |
| Sham Transcranial Direct Current StimulationAlso: tDCSTranscranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability. | Device | Sham and fatigue, Sham and non-fatigue |
Primary outcome
Fatigue Assessment Scale (FAS)
Time frame: through study completion, an average of 8 weeks
Fatigue Questionnaire (1 to 5-point scale x 10 questions for a total score range of 0 to 50) where a low value indicates less fatigued (better outcome) and a high value indicates more fatigued (worse outcome)
Fatigue Severity Scale (FSS)
Time frame: through study completion, an average of 8 weeks
Fatigue Questionnaire (1 to 7 point scale x 9 questions for a total score range of 0 to 63) with a low value indicating less severe fatigue (better outcome) and a high value indicating more severe fatigue (worse outcome)
6-minute Walk Test
Time frame: through study completion, an average of 8 weeks
Distance in meters will be measured in six minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Post Covid-19 Patients
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 recruiting
Long COVID Brain Fog: Cognitive Rehabilitation Trial
Long COVID, Brain Fog
RecruitingPhase 2
SARS-CoV-2 and Herpesvirus Inhibition for Ending Long COVID Dysfunction
Post-acute Sequelae of COVID-19, Long COVID
Enrolling by invitation
Fareon Open Label Device Clinical Trial
Cognitive Dysfunction, Acquired Brain Injury
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
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 Post Covid-19 Patients, run by University of Iowa at 1 site in United States.
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 7 inclusion and 5 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 1 May 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Assessment Scale (FAS) (time frame: through study completion, an average of 8 weeks). The study lists 3 primary outcomes in all. 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 1 May 2024; AzTrials last refreshed its copy on 31 Oct 2026.