N/A
N=74
Transcranial Direct Current Stimulation (tDCS) for Post COVID-19 Fatigue
Post Covid-19 Patients
Bottom Line
View on ClinicalTrials.gov: NCT04876417 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Fatigue Assessment Scale (FAS) — 31.32; 28.42; 14.90; 15.3 Total score (1 to 5 point scale)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial Direct Current Stimulation (Device); Sham Transcranial Direct Current Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Iowa
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fatigue Assessment Scale (FAS) |
31.32; 28.42; 14.90; 15.3 | — |
| PRIMARY Fatigue Severity Scale (FSS) |
5.08; 4.73; 2.13; 1.98 | — |
| PRIMARY 6-minute Walk Test |
435.4; 460.69; 489.01; 451.38 | — |
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.
Eligibility 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
- 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
Exclusion criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04876417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.