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

San Carlos Clinical Hospital

Status: Completed

Conditions: COVID-19

Treatments: Device: Sham tDCS; Device: Active tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05252481

22-120

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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47 participants in 2 patient groups

Active tDCS

Active Comparator group

Description:

Transcranial current direct stimulation. 8 days.

Treatment:

Device: Active tDCS

Sham tDCS

Sham Comparator group

Description:

Sham transcranial current direct stimulation. 8 days.

Treatment:

Device: Sham tDCS