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

NCT04876417 | Completed Results FDA Device

• 1 other identifier: 202009381
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Covid-19 Patients

Keywords

Covid-19; Fatigue

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  through study completion, an average of 8 weeks

• 6-minute Walk Test

  Distance in meters will be measured in six minutes

  through study completion, an average of 8 weeks

Study Arms (4)

tDCS and fatigue

ACTIVE COMPARATOR

This group will receive the active form of tDCS.

Device: Transcranial Direct Current Stimulation

Sham and fatigue

SHAM COMPARATOR

This group will receive the sham form of tDCS.

Device: Sham Transcranial Direct Current Stimulation

tDCS and non-fatigue

ACTIVE COMPARATOR

This group will receive the active form of tDCS.

Device: Transcranial Direct Current Stimulation

Sham and non-fatigue

SHAM COMPARATOR

This group will receive the sham form of tDCS.

Device: Sham Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Also known as: tDCS

tDCS and fatigue; tDCS and non-fatigue

Sham Transcranial Direct Current Stimulation DEVICE

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.

Also known as: tDCS

Sham and fatigue; Sham and non-fatigue

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Department of Health and Human Physiology

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

COVID-19; Fatigue

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Thorsten Rudroff, PhD, Associate Professor
• Organization: University of Iowa

thorsten-rudroff@uiowa.edu

(319) 467-0363

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2021
• First Posted: May 6, 2021
• Study Start: June 15, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 1, 2024
• Results First Posted: May 1, 2024

Record last verified: 2024-04

Locations

US (1)