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OpenTrials
Completed

NCT Number: NCT05252481

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.

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Key information

Conditions

COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Fatigue Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico San Carlos.

Madrid, 28040, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

active tDCS

Device

Eight sessions of transcranial current direct stimulation

Sham tDCS

Device

Eight sessions of transcranial current direct stimulation (sham)

Primary outcomes

  1. Change in Fatigue

    Time frame: 2 weeks

    Modified Fatigue Impact Scale (MFIS)

Secondary outcomes

  1. Change in cognition

    Time frame: 2 weeks

    Stroop Test

  2. Change in depressive symptoms

    Time frame: 2 weeks

    Beck Depression Inventory II

  3. Change in quality of life

    Time frame: 2 weeks

    EuroQuol-5D

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

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

Acronym: STIMULATECOVID

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2022
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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