tDCS in Post-COVID Syndrome: Comparison of Two Targets

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Post-COVID-19 Syndrome; Post COVID-19 Condition
• Intervention / Treatment: Device: transcranial current direct stimulation

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Hospital Clínico San Carlos.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital San Carlos, Madrid
• Investigators: Principal Investigator: Jordi A Matias-Guiu, PhD, Hospital Clinico San Carlos

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: March 1, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 28, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; fatigue; depression; brain stimulation; non-invasive brain stimulation; cognitive; post-COVID syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; COVID-19; Syndrome
• Other Study ID Numbers: 22/728-P-EC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: After the end of the study and publication of the results. For 5 years.
• IPD Sharing Access Criteria: Data will be shared after reasonable request to the principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No