tDCS in Post-COVID Syndrome: Comparison of Two Targets

Study Overview
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Brief Summary
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The main aim of this study is to compare the effect of two non-invasive neuromodulation targets in patients meeting WHO criteria for the post-COVID condition. A randomized, parallel, double-blind study will be conducted. Patients will receive 15 neuromodulation sessions through transcranial electrical stimulation for 3 weeks, associated with cognitive stimulation during therapy. The main objective will be to evaluate the change in physical fatigue. As secondary objectives, changes in cognition, depression, pain, quality of sleep and quality of life will be evaluated. The objective of this study is to evaluate the effect of two targets (left dorsolateral prefrontal and M1) of the neuromodulation intervention, together with cognitive stimulation.

Official Title
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Neuromodulation Using Transcranial Direct Current Stimulation (tDCS) in Post-COVID Syndrome: Comparison of Two Targets

Conditions
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COVID-19, Post-COVID-19 Syndrome, Post COVID-19 Condition

Intervention / Treatment
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* Device: transcranial current direct stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of COVID-19 at least 6 months before the participation in the study. Diagnosis of post-COVID condition according to WHO criteria. Age 18-65 years. Spanish as native language. Sign of written informed consent. Exclusion Criteria: History of stroke History of traumatic brain injury or central nervous system infection Diagnosis of other neurological or medical disorder that could impact on fatigue. Diagnosis of active psychiatric disorder potentially impacting on fatigue or cognitive function. Chemotherapy or radiotherapy for cancer. Severe sensory deficits (e.g. visual loss) that could limit assessments included int the study protocol. Taking drugs or uncontrolled medical disorder potentially causing or worsening fatigue. Specifically, uncontrolled adrenal insufficiency, miastenic syndromes, thyroid disorders, cardiac failure, chronic kidney disorders and neurodegenerative disorders are excluded. History of abuse of alcohol or other toxics. Any contraindication for transcranial electric stimulation: epilepsy, pregnancy, metallic implants, brain devices, pacemakers, head injuries).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Left dorsolateral prefrontal cortex<br>15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training. | Device: transcranial current direct stimulation<br>* Transcranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week)<br>|
| Active Comparator: Left M1<br>15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training. | Device: transcranial current direct stimulation<br>* Transcranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue Severity Scale (score) | Physical fatigue | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Fatigue Impact Scale (MFIS) (score) | Physical and cognitive fatigue | 1 month | 
| FLEI scale (score) | Subjective cognition. | 1 month | 
| Beck Depression Inventory (2nd version) (score) | Depressive symptoms | 1 month | 
| Pittsburgh Sleep Quality Index (score) | Sleep quality | 1 month | 
| Brief Pain Inventory (score) | Pain | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post-COVID syndrome, brain stimulation, fatigue, cognitive, depression, transcranial direct current stimulation, non-invasive brain stimulation