Covid-19 RecurrentCOVID-19NCT06544395
Efficacy of Non-invasive Neuromodulation Treatments for COVID-19 Sequelae
A study testing Non invasive neuromodulation therapy and Manual therapy in people with Covid-19 Recurrent, run by Clinica Gema Leon at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Covid-19 Recurrent
- What is being tested?
- Non invasive neuromodulation therapy and Manual therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Gema León Physiotherapy and Rehabilitation Clinic
Córdoba, Andalusia, 14011
About this study
Official title: Efficacy of Non-invasive Neuromodulation Treatments for Post-COVID-19 Sequelae in Patients With Musculoskeletal, Respiratory and Neurological Conditions Due to Impaired Taste and Smell.
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.
Read more
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.
Read the detailed description
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
- Covid-19 Recurrent
- Being tested
- Non invasive neuromodulation therapy, Manual therapy, Placebo with non invasive neuromodulation
- Keywords
- Covid-19, Non Invasive Neuromodulation, Smell
- Medical subject headings
- COVID-19, Anosmia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non invasive neuromodulation therapyDevice
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 therapyOther
Common manual therapy administered for said pathology by traditional physiotherapy and therapeutic exercise.
Placebo with non invasive neuromodulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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). Receives: Device: Placebo with non invasive neuromodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
sex, age, vaccination and number of months with symptoms
Nominal variables such as sex, age, vaccination and number of months with symptoms
Measured: one month
Number of participants with musculoskeletal, respiratory and neurological sequelae of taste and smell after COVID-19
Measured: three months
Secondary outcomes (10)
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
Measured: two months
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.
Measured: two months
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.
Measured: two months
EuroQoL 5-D scale (validated translation into Spanish) for quality of life.
Quality of life related to health.
Questionaire with two parts:
- Descriptive system (5 items). Minimum value: 1 (absence of dificulties). Maximum value: 3 (plenty of difficulties). Optimal value: 1.
- Visual analogical scale (EVA). Minimum value: 0 (worst imaginable state of health). Maximum value: 100 (best imaginable state of health). Optimal value: 100.
Measured: two months
upper limb functional index
It is used to evaluate functional impairment in people with upper extremity musculoskeletal dysfunction. 25 questions assessing the level of difficulty in performing activities of daily living using your upper extremities, including household and work activities, hobbies, lifting a bag of food, washing your scalp, pushing on your hands, driving, etc. Patients respond to each item by circling the number that best describes their level of difficulty.
Measured: two months
lower limb functional index
Valid patient-rated outcome measure to measure lower extremity function. The lower the score the greater the disability. The minimal detectable change is 9 scale points.
Measured: two months
Visual analogue scale (VAS), for pain assessment
Intensity of pain. Minimum value: 0 (absence of pain). Maximum value: 10 (unbearable pain). Optimal value: 0.
Measured: two months
Sensory assessment for pain and light touch
The sensory exam involves evaluation of pain and light touch. Test pain using a sharp object. At minimum, test the shoulders, arms and legs, comparing side to side and proximal to distal areas. In any area where the patient complains of sensory loss or hypersensitivity, more detailed testing may be required.
For light touch, uses your fingertips or a wisp of cotton, lightly stroke the skin and determine if the patient feels this symmetrically in all areas tested. At minimum, test the shoulders, arms and legs, comparing side to side and proximal to distal areas.
Measured: two months
Sadoul's dyspnea rating scale.
Respiratory evaluation. Minimum value: 0 (absence of dyspnea). Maximum value: 5 (dyspnea occurs with minimal efforts). Optimal value: 0.
Measured: two months
measurement of lung function with spirometry and lung volume testing
measurement of lung function with spirometry and lung volume testing (measurement of maximum inspiratory and expiratory pressures (Pimax and Pemax, respectively)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Jan 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19 RecurrentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Gema Leon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GEMA LEÓN BRAVO, Clinica Gema Leon
- Investigators
- GEMA LEÓN BRAVO, Principal investigator, Departamento de Enfermería, Farmacología y Fisioterapia de la Universidad de Córdoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06544395
- Sponsor's protocol ID
- NO INVASIV NEUROMOD COVID-19
- Other IDs
- NO INVASIVE NEUROM-COVID-19
- Acronym
- COVID-19
- Status last verified
- Sep 2025
- First submitted
- 6 Aug 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Non-invasive Neuromodulation Treatments for Post-COVID-19 Sequelae in Patients With Musculoskeletal, Respiratory and Neurological Conditions Due to Impaired Taste and Smell.
- ClinicalTrials.gov ID
- NCT06544395
- Acronym / sponsor ID
- COVID-19 / NO INVASIV NEUROMOD COVID-19
- Conditions
- Covid-19 Recurrent
- Keywords
- Covid-19, Non Invasive Neuromodulation, Smell
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Clinica Gema LeonUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 9 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients receiving non invasive neuromodulation treatment. | Experimental | Device: Non invasive neuromodulation therapyPatients 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. |
| Patients receiving traditional treatment. | Active comparator | Other: Manual therapyPatients 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. |
| Patients receiving placebo treatment. | Placebo comparator | Device: Placebo with non invasive neuromodulationPatients 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). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non invasive neuromodulation therapyIn 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. | Device | Patients receiving non invasive neuromodulation treatment. |
| Manual therapyCommon manual therapy administered for said pathology by traditional physiotherapy and therapeutic exercise. | Other | Patients receiving traditional treatment. |
| Placebo with non invasive neuromodulationIn 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. | Device | Patients receiving placebo treatment. |
Primary outcome
ad hoc patient survey
Time frame: one month
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.
sex, age, vaccination and number of months with symptoms
Time frame: one month
Nominal variables such as sex, age, vaccination and number of months with symptoms
Number of participants with musculoskeletal, respiratory and neurological sequelae of taste and smell after COVID-19
Time frame: three months
10 secondary outcomes
SDOQ-NS questionnaire for social impairments due to loss of smell
Time frame: two months
SF12 Quality of Life Questionnaire
Time frame: two months
Brief Smell Identification Test: Assessment of smell.
Time frame: two months
EuroQoL 5-D scale (validated translation into Spanish) for quality of life.
Time frame: two months
upper limb functional index
Time frame: two months
lower limb functional index
Time frame: two months
Visual analogue scale (VAS), for pain assessment
Time frame: two months
Sensory assessment for pain and light touch
Time frame: two months
Sadoul's dyspnea rating scale.
Time frame: two months
measurement of lung function with spirometry and lung volume testing
Time frame: three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Covid-19 Recurrent
Active, not recruitingObservational study
Long COVID and Its Associations With Health Outcomes in Older Adults
Long COVID, COVID-19 Pandemic
Recruiting
COVID-19 Vaccine Effectiveness Against Recurrent Infection Among Lung Cancer Patients and Biomarker Research
COVID-19 Recurrent, Lung Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GEMA LEÓN BRAVO principal investigator
Departamento de Enfermería, Farmacología y Fisioterapia de la Universidad de Córdoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non invasive neuromodulation therapy and Manual therapy in people with Covid-19 Recurrent, run by Clinica Gema Leon at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GEMA LEÓN BRAVO (+34667401116, gemafisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ad hoc patient survey (time frame: one month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.