STIMULATECOVID: Transcranial Direct Stimulation for Persistent Fatigue Treatment Post-COVID-19
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 |
---|---|---|
|
N/A |
Study Design
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
- Change in Fatigue [2 weeks]
Modified Fatigue Impact Scale (MFIS)
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of COVID-19 with PCR-confirmation.
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Fatigue linked to COVID-19
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No diagnosis of neurological, psychiatric or medical disorder with potential impact on fatigue.
Exclusion Criteria:
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Stroke before COVID-19
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History of traumatic brain lesion or central nervous system infection previous to COVID-19
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Radiotherapy or chemotherapy for cancer
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Severe sensorial deficits
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Drugs or uncontrolled medical disorder with potential impact on fatigue.
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History of abuse of alcohol or other toxics.
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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.- 22-120