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

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Active tDCS
Sham tDCS
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Post-COVID-19 syndrome, Post-COVID-19 condition, Persistent COVID-19, Long-Haul COVID-19, Fatigue

Eligibility Criteria

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

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).

Sites / Locations

  • Hospital Clínico San Carlos.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

Transcranial current direct stimulation. 8 days.

Sham transcranial current direct stimulation. 8 days.

Outcomes

Primary Outcome Measures

Change in Fatigue
Modified Fatigue Impact Scale (MFIS)

Secondary Outcome Measures

Change in cognition
Stroop Test
Change in depressive symptoms
Beck Depression Inventory II
Change in quality of life
EuroQuol-5D

Full Information

First Posted
February 19, 2022
Last Updated
August 18, 2022
Sponsor
Hospital San Carlos, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05252481
Brief Title
Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
Acronym
STIMULATECOVID
Official Title
Modulation of Post-COVID-19 Fatigue Using Transcranial Direct Current Stimulation. Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
June 26, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Post-COVID-19 syndrome, Post-COVID-19 condition, Persistent COVID-19, Long-Haul COVID-19, Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
47 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
Transcranial current direct stimulation. 8 days.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham transcranial current direct stimulation. 8 days.
Intervention Type
Device
Intervention Name(s)
Active tDCS
Intervention Description
Eight sessions of transcranial current direct stimulation
Intervention Type
Device
Intervention Name(s)
Sham tDCS
Intervention Description
Eight sessions of transcranial current direct stimulation (sham)
Primary Outcome Measure Information:
Title
Change in Fatigue
Description
Modified Fatigue Impact Scale (MFIS)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Change in cognition
Description
Stroop Test
Time Frame
2 weeks
Title
Change in depressive symptoms
Description
Beck Depression Inventory II
Time Frame
2 weeks
Title
Change in quality of life
Description
EuroQuol-5D
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
Hospital Clínico San Carlos.
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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