- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04876417
tDCS for Post COVID-19 Fatigue
February 24, 2023 updated by: Thorsten Rudroff
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Thorsten Rudroff, PHD
- Phone Number: 3194670363
- Email: thorsten-rudroff@uiowa.edu
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- Recruiting
- Department of Health and Human Physiology
-
Contact:
- Thorsten Rudroff, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: tDCS and fatigue
This group will receive the active form of 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.
Other Names:
|
Sham Comparator: Sham and fatigue
This group will receive the sham form of 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Assessment Scale (FAS)
Time Frame: through study completion, an average of 1 year
|
Fatigue Questionnaire
|
through study completion, an average of 1 year
|
Fatigue Severity Scale (FSS)
Time Frame: through study completion, an average of 1 year
|
Fatigue Questionnaire
|
through study completion, an average of 1 year
|
Fatigue testing of the knee muscles of both legs
Time Frame: through study completion, an average of 1 year
|
Fatigue task on an isokinetic machine
|
through study completion, an average of 1 year
|
6-minute walk test
Time Frame: through study completion, an average of 1 year
|
Distance will be measured
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 15, 2022
Primary Completion (Anticipated)
April 30, 2023
Study Completion (Anticipated)
April 30, 2023
Study Registration Dates
First Submitted
March 15, 2021
First Submitted That Met QC Criteria
May 5, 2021
First Posted (Actual)
May 6, 2021
Study Record Updates
Last Update Posted (Estimate)
February 27, 2023
Last Update Submitted That Met QC Criteria
February 24, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202009381
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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