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NCT05252481 Clinical Trial

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

COVID-19 Clinical Trial

— STIMULATECOVID  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05252481
Other study ID # 22-120
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date July 31, 2022

Study information
Verified date August 2022
Source Hospital San Carlos, Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date July 31, 2022
Est. primary completion date June 26, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Active tDCS
Eight sessions of transcranial current direct stimulation
• Sham tDCS
Eight sessions of transcranial current direct stimulation (sham)

Locations
Country Name City State
Spain Hospital Clínico San Carlos. Madrid

Sponsors (1)
Lead Sponsor Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Fatigue Modified Fatigue Impact Scale (MFIS) 2 weeks
Secondary Change in cognition Stroop Test 2 weeks
Secondary Change in depressive symptoms Beck Depression Inventory II 2 weeks
Secondary Change in quality of life EuroQuol-5D 2 weeks
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