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Transcranial Direct Current Stimulation (tDCS) for Post COVID-19 Fatigue

Transcranial Direct Current Stimulation (tDCS) for the Treatment of Fatigue in Post-COVID-19 Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04876417
Enrollment
74
Registered
2021-05-06
Start date
2022-06-15
Completion date
2023-04-30
Last updated
2024-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Covid-19 Patients

Keywords

Covid-19, Fatigue

Brief 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. 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.

Interventions

DEVICETranscranial Direct Current Stimulation

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.

DEVICESham Transcranial Direct Current Stimulation

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.

Sponsors

University of Iowa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Only those that are discharged from the UIHC COVID-19 inpatient clinic and/or that meet the CDC guidelines for discontinuing home isolation (i.e., fever free for at least 24 hours, all symptoms improved after 10 days) will initially be considered as long as they meet the rest of the following criteria: Inclusion criteria 1. 18-80 yrs. 2. Meet CDC guidelines (https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html) for discontinuation of home isolation 3. Meet the criteria for fatigue, based on the Chalder Fatigue Scale CFQ-11 case definition of fatigue 4. Healthy enough to complete the protocol based, on information obtained from a clinical exam and past medical history, such as cardiovascular disease. 5. Comprehension of the protocol, as indicated by an ability to respond to questions about the study after reading the consent form. 6. Able to use and be contacted by telephone 7. Able to speak, read, and understand English, and complete questionnaires in English

Exclusion criteria

1. 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 2. History/presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia 3. Alcohol dependence or abuse (\>2 drinks/day), or present history of drug abuse (last six months) 4. History of significant traumatic brain injury or hydrocephalus 5. Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
6-minute Walk Testthrough study completion, an average of 8 weeksDistance in meters will be measured in six minutes
Fatigue Assessment Scale (FAS)through study completion, an average of 8 weeksFatigue 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)through study completion, an average of 8 weeksFatigue 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)

Countries

United States

Participant flow

Participants by arm

ArmCount
tDCS and Fatigue
This group will receive the active form of tDCS. Transcranial Direct Current Stimulation: 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.
22
Sham and Fatigue
This group will receive the sham form of tDCS. Sham Transcranial Direct Current Stimulation
19
tDCS and Non-fatigue
This group will receive the active form of tDCS. Transcranial Direct Current Stimulation: 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.
10
Sham and Non-fatigue
This group will receive the sham form of tDCS. Sham Transcranial Direct Current Stimulation
10
Total61

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyLost to Follow-up5800

Baseline characteristics

CharacteristictDCS and FatigueSham and FatiguetDCS and Non-fatigueSham and Non-fatigueTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
22 Participants19 Participants10 Participants10 Participants61 Participants
Age, Continuous37.23 Years
STANDARD_DEVIATION 11.71
36.74 Years
STANDARD_DEVIATION 14.37
30.13 Years
STANDARD_DEVIATION 10.02
30.13 Years
STANDARD_DEVIATION 10.02
34.30 Years
STANDARD_DEVIATION 14.13
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants2 Participants0 Participants2 Participants5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
21 Participants17 Participants10 Participants8 Participants56 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants0 Participants1 Participants3 Participants
Race (NIH/OMB)
More than one race
2 Participants1 Participants0 Participants1 Participants4 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants1 Participants1 Participants1 Participants3 Participants
Race (NIH/OMB)
White
17 Participants17 Participants9 Participants6 Participants49 Participants
Region of Enrollment
United States
22 Participants19 Participants10 Participants10 Participants61 Participants
Sex: Female, Male
Female
16 Participants14 Participants6 Participants7 Participants43 Participants
Sex: Female, Male
Male
6 Participants5 Participants4 Participants3 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 270 / 270 / 100 / 10
other
Total, other adverse events
0 / 270 / 270 / 100 / 10
serious
Total, serious adverse events
0 / 270 / 270 / 100 / 10

Outcome results

Primary

6-minute Walk Test

Distance in meters will be measured in six minutes

Time frame: through study completion, an average of 8 weeks

ArmMeasureValue (MEAN)Dispersion
tDCS and Fatigue6-minute Walk Test435.4 metersStandard Deviation 70.47
Sham and Fatigue6-minute Walk Test460.69 metersStandard Deviation 58.67
tDCS and Non-fatigue6-minute Walk Test489.01 metersStandard Deviation 68.11
Sham and Non-fatigue6-minute Walk Test451.38 metersStandard Deviation 65.86
Primary

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)

Time frame: through study completion, an average of 8 weeks

ArmMeasureValue (MEAN)Dispersion
tDCS and FatigueFatigue Assessment Scale (FAS)31.32 Total score (1 to 5 point scale)Standard Deviation 8.41
Sham and FatigueFatigue Assessment Scale (FAS)28.42 Total score (1 to 5 point scale)Standard Deviation 6.41
tDCS and Non-fatigueFatigue Assessment Scale (FAS)14.90 Total score (1 to 5 point scale)Standard Deviation 3.63
Sham and Non-fatigueFatigue Assessment Scale (FAS)15.3 Total score (1 to 5 point scale)Standard Deviation 4.57
Primary

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)

Time frame: through study completion, an average of 8 weeks

ArmMeasureValue (MEAN)Dispersion
tDCS and FatigueFatigue Severity Scale (FSS)5.08 Total score (1-7 point scale)Standard Deviation 1.6
Sham and FatigueFatigue Severity Scale (FSS)4.73 Total score (1-7 point scale)Standard Deviation 1.14
tDCS and Non-fatigueFatigue Severity Scale (FSS)2.13 Total score (1-7 point scale)Standard Deviation 0.61
Sham and Non-fatigueFatigue Severity Scale (FSS)1.98 Total score (1-7 point scale)Standard Deviation 0.55

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026