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tDCS for Post COVID-19 Fatigue

Primary Purpose

Post Covid-19 Patients

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation
Sponsored by
Thorsten Rudroff
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Covid-19 Patients focused on measuring Covid-19, Fatigue

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Health and Human PhysiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

tDCS and fatigue

Sham and fatigue

Arm Description

This group will receive the active form of tDCS.

This group will receive the sham form of tDCS.

Outcomes

Primary Outcome Measures

Fatigue Assessment Scale (FAS)
Fatigue Questionnaire
Fatigue Severity Scale (FSS)
Fatigue Questionnaire
Fatigue testing of the knee muscles of both legs
Fatigue task on an isokinetic machine
6-minute walk test
Distance will be measured

Secondary Outcome Measures

Full Information

First Posted
March 15, 2021
Last Updated
February 24, 2023
Sponsor
Thorsten Rudroff
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1. Study Identification

Unique Protocol Identification Number
NCT04876417
Brief Title
tDCS for Post COVID-19 Fatigue
Official Title
Transcranial Direct Current Stimulation (tDCS) for the Treatment of Fatigue in Post-COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thorsten Rudroff

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Covid-19 Patients
Keywords
Covid-19, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS and fatigue
Arm Type
Active Comparator
Arm Description
This group will receive the active form of tDCS.
Arm Title
Sham and fatigue
Arm Type
Sham Comparator
Arm Description
This group will receive the sham form of tDCS.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fatigue Assessment Scale (FAS)
Description
Fatigue Questionnaire
Time Frame
through study completion, an average of 1 year
Title
Fatigue Severity Scale (FSS)
Description
Fatigue Questionnaire
Time Frame
through study completion, an average of 1 year
Title
Fatigue testing of the knee muscles of both legs
Description
Fatigue task on an isokinetic machine
Time Frame
through study completion, an average of 1 year
Title
6-minute walk test
Description
Distance will be measured
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thorsten Rudroff, PHD
Phone
3194670363
Email
thorsten-rudroff@uiowa.edu
Facility Information:
Facility Name
Department of Health and Human Physiology
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thorsten Rudroff, PhD

12. IPD Sharing Statement

Learn more about this trial

tDCS for Post COVID-19 Fatigue

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