tDCS in Post-COVID Syndrome: Comparison of Two Targets

Not Applicable

Active, not recruiting

• Conditions: COVID-19; Post-COVID-19 Syndrome; Post COVID-19 Condition
• Interventions: Device: transcranial current direct stimulation

• Registration Number: NCT05753202
• Lead Sponsor: Hospital San Carlos, Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-03-01
• Study First Submitted QC: 2023-03-01
• Study First Posted: 2023-03-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-28
• Last Update Posted: 2024-01-30
• Primary Completion: 2024-03-01
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Left dorsolateral prefrontal cortex	transcranial current direct stimulation	15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training.
Left M1	transcranial current direct stimulation	15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training.

Primary Outcome Measures

Name	Time	Method
Fatigue Severity Scale (score)	1 month	Physical fatigue

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clínico San Carlos.; 🇪🇸 Madrid, Spain