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

ConditionCovid-19 Recurrent
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorClinica Gema Leon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Non invasive neuromodulation therapy

    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.

  • Manual therapy

    Other intervention

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

  • Placebo with non invasive neuromodulation

    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.

Treatment groups

104 Participants
are divided into 3 treatment groups
Group A: Patients receiving non invasive neuromodulation treatment.Experimental treatment 1 intervention
Group B: Patients receiving traditional treatment.Active comparator 1 intervention
Group C: Patients receiving placebo treatment.Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

ad hoc patient survey

survey of patients about conditions diagnosed during the illness and those they suffer from after infection that are directly related to abnormalities to be assessed.

Time frame
one month
2

sex, age, vaccination and number of months with symptoms

Nominal variables such as sex, age, vaccination and number of months with symptoms

Time frame
one month
3

Number of participants with musculoskeletal, respiratory and neurological sequelae of taste and smell after COVID-19

Time frame
three months

Secondary outcomes

1

SDOQ-NS questionnaire for social impairments due to loss of smell

Assess the quality of life impairments of patients with olfactory dysfunction. In a scale of 0 to 3, with higher scores reflecting better olfactory-specific

Time frame
two months
2

SF12 Quality of Life Questionnaire

Assesses the impact of health on an individual's everyday life. Scores above 50 indicate a better-than-average health-related quality of life, while scores below 50 suggest below-average health.

Time frame
two months
3

Brief Smell Identification Test: Assessment of smell.

Assesses the ability to recognize familiar odors. A 12-item questionnaire. For each item, a microcapsule containing a familiar odor is scratched with a pencil and placed under the participant's nose. The total score is the number of odors that are correctly recognized. Missing responses are assigned a partial score of 0.25. If more than 2 responses are missing, the entire test is treated as missing.

Time frame
two months
4

EuroQoL 5-D scale (validated translation into Spanish) for quality of life.

Quality of life related to health. Questionaire with two parts: 1. Descriptive system (5 items). Minimum value: 1 (absence of dificulties). Maximum value: 3 (plenty of difficulties). Optimal value: 1. 2. Visual analogical scale (EVA). Minimum value: 0 (worst imaginable state of health). Maximum value: 100 (best imaginable state of health). Optimal value: 100.

Time frame
two months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinica Gema Leon

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: