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

Sponsor
Hospital San Carlos, Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT05252481
Collaborator
(none)
47
1
2
4
11.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Active tDCS
  • Device: Sham tDCS
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
Actual Study Start Date :
Apr 1, 2022
Actual Primary Completion Date :
Jun 26, 2022
Actual Study Completion Date :
Jul 31, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Change in Fatigue [2 weeks]

    Modified Fatigue Impact Scale (MFIS)

Secondary Outcome Measures

  1. Change in cognition [2 weeks]

    Stroop Test

  2. Change in depressive symptoms [2 weeks]

    Beck Depression Inventory II

  3. Change in quality of life [2 weeks]

    EuroQuol-5D

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital ClĂ­nico San Carlos. Madrid Spain 28040

Sponsors and Collaborators

  • Hospital San Carlos, Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jordi A Matias-Guiu, PhD MD, Hospital San Carlos, Madrid
ClinicalTrials.gov Identifier:
NCT05252481
Other Study ID Numbers:
  • 22-120
First Posted:
Feb 23, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Jordi A Matias-Guiu, PhD MD, Hospital San Carlos, Madrid
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022