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

Not Applicable

Completed

• Conditions: COVID-19
• Interventions: Device: Active tDCS; Device: Sham tDCS

• Registration Number: NCT05252481
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-02-21
• Study First Posted: 2022-02-23
• Study Start: 2022-04-01
• Primary Completion: 2022-06-26
• Study Completion: 2022-07-31
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active tDCS	Active tDCS	Transcranial current direct stimulation. 8 days.
Sham tDCS	Sham tDCS	Sham transcranial current direct stimulation. 8 days.

Primary Outcome Measures

Name	Time	Method
Change in Fatigue	2 weeks	Modified Fatigue Impact Scale (MFIS)

Secondary Outcome Measures

Name	Time	Method
Change in cognition	2 weeks	Stroop Test
Change in depressive symptoms	2 weeks	Beck Depression Inventory II
Change in quality of life	2 weeks	EuroQuol-5D

Trial Locations

Locations (1)

Hospital Clínico San Carlos.; 🇪🇸 Madrid, Spain