tDCS in Post-COVID Syndrome: Comparison of Two Targets

NCT05753202 | Unknown

• 1 other identifier: 22/728-P-EC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Post-COVID-19 Syndrome; Post COVID-19 Condition

Keywords

post-COVID syndrome; brain stimulation; fatigue; cognitive; depression; transcranial direct current stimulation; non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Fatigue Severity Scale (score)

  Physical fatigue

  1 month

Secondary Outcomes (5)

• Modified Fatigue Impact Scale (MFIS) (score)

  1 month

• FLEI scale (score)

  1 month

• Beck Depression Inventory (2nd version) (score)

  1 month

• Pittsburgh Sleep Quality Index (score)

  1 month

• Brief Pain Inventory (score)

  1 month

Study Arms (2)

Left dorsolateral prefrontal cortex

ACTIVE COMPARATOR

15 sessiones of anodal tDCS over the left dorsolateral prefrontal cortex (2 mA, 20 minutes) associated with cognitive training.

Device: transcranial current direct stimulation

Left M1

ACTIVE COMPARATOR

15 sessiones of anodal tDCS over the left M1 (2 mA, 20 minutes) associated with cognitive training.

Device: transcranial current direct stimulation

Interventions

transcranial current direct stimulation DEVICE

Transcranial electrical stimulation over two different brain regions associated with cognitive training. 15 sesions in 3 weeks (5 days/week)

Left M1; Left dorsolateral prefrontal cortex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital San Carlos, Madrid: lead

Study Sites (1)

Hospital Clínico San Carlos.

Madrid, 28040, Spain

Location

Related Publications (1)

• Oliver-Mas S, Matias-Guiu JA, Delgado-Alonso C, Gil-Martinez L, Cuevas C, Polidura C, Fernandez-Romero L, Matias-Guiu A, Gomez-Ruiz N, Gil-Moreno MJ, Yus-Fuertes M, Matias-Guiu J, Diez-Cirarda M. A randomized comparative feasibility study of neuromodulation and cognitive training for post-COVID fatigue. Sci Rep. 2025 Jul 23;15(1):26818. doi: 10.1038/s41598-025-09772-8.

  PMID: 40702022 DERIVED

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome; Fatigue; Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Jordi A Matias-Guiu, PhD

  Hospital Clinico San Carlos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD MD

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 3, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: June 30, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: After the end of the study and publication of the results. For 5 years.
• Access Criteria: Data will be shared after reasonable request to the principal investigator.

Locations

ES (1)