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

NCT06544395 | Not Yet Recruiting DMC

• 2 other identifiers: NO INVASIV NEUROMOD COVID-19NO INVASIVE NEUROM-COVID-19
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid-19 Recurrent

Keywords

Covid-19; Non Invasive Neuromodulation; Smell

Outcome Measures

Primary Outcomes (3)

• 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.

  one month

• sex, age, vaccination and number of months with symptoms

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

  one month

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

  three months

Secondary Outcomes (10)

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

  two months

• SF12 Quality of Life Questionnaire

  two months

• Brief Smell Identification Test: Assessment of smell.

  two months

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

  two months

• upper limb functional index

  two months

Study Arms (3)

Patients receiving non invasive neuromodulation treatment.

EXPERIMENTAL

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.

Device: Non invasive neuromodulation therapy

Patients receiving traditional treatment.

ACTIVE COMPARATOR

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.

Other: Manual therapy

Patients receiving placebo treatment.

PLACEBO COMPARATOR

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).

Device: Placebo with non invasive neuromodulation

Interventions

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.

Patients receiving non invasive neuromodulation treatment.

Manual therapy OTHER

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

Patients receiving traditional treatment.

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.

Patients receiving placebo treatment.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Gema Leon: lead

Study Sites (1)

Gema León Physiotherapy and Rehabilitation Clinic

Córdoba, Andalusia, 14011, Spain

Location

MeSH Terms

Conditions

COVID-19; Anosmia

Interventions

Musculoskeletal Manipulations

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; Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• GEMA LEÓN BRAVO

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GEMA LEÓN BRAVO

CONTACT

+34667401116; gemafisio@gmail.com

GEMA LEÓN BRAVO

CONTACT

+34667401116; gemaleonbravo@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)