Efficacy of Non-invasive Neuromodulation Treatments for COVID-19 Sequelae

NCT ID: NCT06544395

Last Updated: 2025-09-18

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-30

Brief Summary

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The goal of this clinical trial is to demonstrate the effectiveness of non-invasive Neuromodulation as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19. It will also estimate the impact of non-invasive neuromodulation treatment on the functionality and quality of life of patients with COVID-19 sequelae.The main question it aim to answer is:

\- Is non-invasive neuromodulation effective as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19.

Researchers will compare non-invasive neuromodulation to a placebo (treatment with the machine turned off).

Participants will:

* Be evaluated before starting treatment.
* Be evaluated 3 weeks after.
* Be evaluated at 5 weeks, or 15 sessions or completion of treatment.
* Be evaluated 6 weeks after finishing the treatment or 11 weeks after starting treatment.

Detailed Description

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The waves of Sars-Cov-2 disease continue to be continuous and we are increasingly aware of the consequences it causes both in the respiratory system, musculoskeletal system and in the central and peripheral nervous system.

Likewise, non-invasive neuromodulation acts with a pump of ions, generating endogenous stimuli that modulate the central nervous system.

The aim of this clinical trial is to demonstrate the effectiveness of non-invasive Neuromodulation as a therapy in neurological, respiratory and musculoskeletal pathologies derived from the consequences of Covid-19.

To carry out this study, pain was measured with the visual analogue scale. It was also measured the joint amplitude, a muscle assessment with the help of a strength dynamometer, the patient's independence with the Katz index and the functionality of the lower or upper limbs, depending on the affected joint.

Conditions

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Covid-19 Recurrent

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Patients receiving non invasive neuromodulation treatment.

Patients without previous pathology of any kind who have passed the Covid19 and have respiratory, neurological or musculoskeletal sequelae; who will receive non invasive neuromodulation treatment.

Group Type EXPERIMENTAL

Non invasive neuromodulation therapy

Intervention Type DEVICE

In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks.

Each intervention lasted 60 minutes. The intensity will be programmed in all sessions at Low, following the Arndt-Schulz law. The treatment was distributed in 3 phases: phase 1 of preparation, phase 2 to reduce fatigue and phase 3 to enhance autonomic improvement.

Patients receiving traditional treatment.

Patients receiving only traditional therapy. Patients without previous pathology of any kind who have passed the Covid19 and have respiratory, neurological or musculoskeletal sequelae; who will receive treatment of traditional therapy.

Group Type ACTIVE_COMPARATOR

Manual therapy

Intervention Type OTHER

Common manual therapy administered for said pathology by traditional physiotherapy and therapeutic exercise.

Patients receiving placebo treatment.

Patients receiving placebo. Patients without previous pathology of any kind who have passed the Covid19 and have respiratory, neurological or musculoskeletal sequelae; to those who will be administered placebo (device off, without emitting).

Group Type PLACEBO_COMPARATOR

Placebo with non invasive neuromodulation

Intervention Type DEVICE

In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks.

Each intervention lasted 60 minutes. The treatment was carried out with the machine turned off.

Interventions

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Non invasive neuromodulation therapy

In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks.

Each intervention lasted 60 minutes. The intensity will be programmed in all sessions at Low, following the Arndt-Schulz law. The treatment was distributed in 3 phases: phase 1 of preparation, phase 2 to reduce fatigue and phase 3 to enhance autonomic improvement.

Intervention Type DEVICE

Manual therapy

Common manual therapy administered for said pathology by traditional physiotherapy and therapeutic exercise.

Intervention Type OTHER

Placebo with non invasive neuromodulation

In the 4 studies, the intervention consisted of 15 sessions spread over 5 weeks.

Each intervention lasted 60 minutes. The treatment was carried out with the machine turned off.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients between the ages of 18 and 60.
* Patients with a positive diagnosis of COVID-19.
* Patients with post-COVID-19 sequelae with musculoskeletal, respiratory or neurological symptoms due to taste or smell lasting at least 30 days, with no history of respiratory and/or neurological and/or musculoskeletal diseases.
* Patients who signed the informed consent.

Exclusion Criteria

* Patients aged before 18 years and after 60 years.
* Healthy people with no history of neurological, neurological and/or respiratory and/or musculoskeletal diseases
* Patients with secondary diseases that could directly affect the systems to be evaluated who were not diagnosed positive for COVID-19.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinica Gema Leon

OTHER

Sponsor Role lead

Responsible Party

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GEMA LEÓN BRAVO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GEMA LEÓN BRAVO

Role: PRINCIPAL_INVESTIGATOR

Departamento de Enfermería, Farmacología y Fisioterapia de la Universidad de Córdoba

Locations

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Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, Spain

Site Status

Countries

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Spain

Central Contacts

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GEMA LEÓN BRAVO

Role: CONTACT

+34667401116

GEMA LEÓN BRAVO

Role: CONTACT

+34667401116

Other Identifiers

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NO INVASIVE NEUROM-COVID-19

Identifier Type: OTHER

Identifier Source: secondary_id

NO INVASIV NEUROMOD COVID-19

Identifier Type: -

Identifier Source: org_study_id

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