tDCS in Post-COVID Syndrome: Comparison of Two Targets

NCT ID: NCT05753202

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-06-30

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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Left dorsolateral prefrontal cortex

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

Group Type ACTIVE_COMPARATOR

transcranial current direct stimulation

Intervention Type DEVICE

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

Left M1

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

Group Type ACTIVE_COMPARATOR

transcranial current direct stimulation

Intervention Type DEVICE

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

Interventions

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transcranial current direct stimulation

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

Intervention Type DEVICE

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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Carlos, Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jordi A Matias-Guiu

PhD MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jordi A Matias-Guiu, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinico San Carlos

Locations

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Hospital ClĂ­nico San Carlos.

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 40702022 (View on PubMed)

Other Identifiers

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22/728-P-EC

Identifier Type: -

Identifier Source: org_study_id

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