Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19 (STIMULATECOVID)

August 18, 2022 updated by: Jordi A Matias-Guiu, Hospital San Carlos, Madrid

Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19

Fatigue is common and disabling in patients with post-COVID syndrome. There is no treatment available at this moment, and fatigue has important consequences. The main aim of this study is to evaluate the changes in the severity of fatigue using non-invasive neuromodulation in patients with post-COVID condition. This is a randomized, parallel, double-blind, placebo-controlled clinical trial using transcranial direct current stimulation. Secondary aims include changes in cognition, depression, and quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

47

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 Locations

  • Spain
      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of COVID-19 with PCR-confirmation.
  • Fatigue linked to COVID-19
  • No diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue.

Exclusion Criteria:

  • Stroke before COVID-19
  • History of traumatic brain lesion or central nervous system infection previous to COVID-19
  • Radiotherapy or chemotherapy for cancer
  • Severe sensorial deficits
  • Drugs or uncontrolled medical disorder with potential impact on fatigue.
  • History of abuse of alcohol or other toxics.
  • Any contraindication for tDCS (metallic implants, brain devices, pacemakers, head injuries).

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active tDCS
Transcranial current direct stimulation. 8 days.
Device: Active tDCS
Eight sessions of transcranial current direct stimulation
Sham Comparator: Sham tDCS
Sham transcranial current direct stimulation. 8 days.
Device: Sham tDCS
Eight sessions of transcranial current direct stimulation (sham)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Fatigue
Time Frame: 2 weeks
Modified Fatigue Impact Scale (MFIS)
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cognition
Time Frame: 2 weeks
Stroop Test
2 weeks
Change in depressive symptoms
Time Frame: 2 weeks
Beck Depression Inventory II
2 weeks
Change in quality of life
Time Frame: 2 weeks
EuroQuol-5D
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Carlos, Madrid

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)

April 1, 2022

Primary Completion (Actual)

June 26, 2022

Study Completion (Actual)

July 31, 2022

Study Registration Dates

First Submitted

February 19, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

February 23, 2022

Study Record Updates

Last Update Posted (Actual)

August 22, 2022

Last Update Submitted That Met QC Criteria

August 18, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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