CoronavirusNCT05359770
Association of Inspiratory Muscle Training With HD-tDCS for Assistance to Patients With Long Covid-19
A study testing Active HD-tDCS in people with Coronavirus and Inspiratory Muscle Training, run by Suellen Marinho Andrade at 1 site in Brazil.
Trial summary
COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronavirus, Inspiratory Muscle Training, Respiratory Infection
- What is being tested?
- Active HD-tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Sep 2021to 20 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled.
Who cannot join
- Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Suellen Andrade, pHD
João Pessoa, Paraíba
Suellen Andrade, PhD, 986046032, suellenandrade@gmail.com
Tainá Cordeiro, +5583986681691, iaratainacordeiro@gmail.com
About this study
Official title: Effects of an Inspiratory Muscle Training Protocol Associated With Neurological Stimulation by HD-tDCS on the Diaphragmatic Cortex in Post-COVID-19 Subjects
COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue), neurological complications and and mainly disorders of the respiratory system, such as respiratory muscle weakness after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation (tDCS) have been proposed to minimize functional and structural impairments. The aim of the present study is to evaluate the effects of inspiratory muscle training associated with stimulation of the diaphragmatic motor cortex through hd-tdcs in post-COVID-19 patients on inspiratory muscle strength, pulmonary function, inflammatory levels and functional capacity.
- Being tested
- Active HD-tDCS, Control group
- Keywords
- Transcranial direct current stimulation, Non-invasive brain stimulation, Inspiratory muscle training, Functional capacity, Maximal inspiratory pressure
- Medical subject headings
- Coronavirus Infections, Respiratory Tract Infections, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active HD-tDCSDevice
Experimental group: 10-sessions of anodal HD-tDCS ( tDCS 1x1, developed by Soterix Medical Inc.) associated to respiratory training; for 20 minutes (each session). It will be delivered a 3mA intensity electrical current accordingly 10/20 International System on cortical representation zone of left diaphragmatic motor cortex using HD-tDCS.
Control groupDevice
Also called Sham control
Sham Control: 10-sessions of anodal HD-tDCS( tDCS 1x1, developed by Soterix Medical Inc.) associated to respiratory training; for 20 minutes (each session) with a 3mA intensity. The device will provide a 30-second ramp-up followed immediately by a 30-second ramp down.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Experimental: Experimental Group/ Active HD-tDCS Patients randomly enrolled in this group will receive 10 sessions of anodal HD-tDCS stimulation on cortical representation zone of left diaphragmatic motor cortex associated to respiratory training; for 20 minutes (each session) with a 2mA intensity. The electrical current will be delivered with a ramp-up time of 30 s, held at 3mA for 20 min, and then ramped down over 30 s. Receives: Device: Active HD-tDCS; Device: Control group |
| Sham Comparator | Sham comparator | Sham Comparator: Control Group / Sham Group In the sham condition, the device will provide a 30-second ramp-up followed immediately by a 30-second ramp down in HD-tDCS associated with inspiratory muscle training for 20 minutes Receives: Device: Active HD-tDCS; Device: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure
Maximal inspiratory pressure response to inspiratory muscle training in association with diaphragmatic motor cortex neurostimulation
Measured: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary outcomes (5)
Functional capacity
Compare baseline to treatment responses in the distance covered on the 6-minute walk test (6MWT). Its measurement has focused on the examination on a broader health indicator than morbidity, as it is correlated with quality of life.
Measured: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Forced vital capacity (FVC), forced expiratory volume 1st second (FEV1) and peak expiratory flow (PEF) by spirometry
Data of pulmonary function given by FCV, FEV1 and PEF will be assessed before and after pulmonary responses using spirometry
Measured: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Inflammatory biomarkers
Correlate levels of inflammatory markers (interleukin-6 and C-reactive protein) with inspiratory muscle training and/or diaphragmatic motor cortex neurostimulation
Measured: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Body composition by bioelectrical impedance
Body composition analysis (body fat composition, muscle mass composition, body mass index) will be carried out by bioelectrical impedance analysis
Measured: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Depression level with Hamilton Anxiety Rating Scale (score 0 to 58)
Anxiety level will be evaluate through Hamilton Anxiety Rating Scale which measures the severity of anxiety symptoms in a score 0 to 58. In current practice, it is accepted that scores greater than 25 points characterize severely depressed patients, scores between 18 and 24 points characterize moderately depressed patients, and scores between 7 and 17 points characterize patients with mild depression.
Measured: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start22 Sep 2021
- Primary completion20 Aug 2022
- Study completion20 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suellen Marinho Andrade
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Suellen Marinho Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359770
- Sponsor's protocol ID
- FUniversity of Paraíba
- Status last verified
- Sep 2022
- First submitted
- 22 Mar 2022
- Last updated
- 2 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Inspiratory Muscle Training Protocol Associated With Neurological Stimulation by HD-tDCS on the Diaphragmatic Cortex in Post-COVID-19 Subjects
- ClinicalTrials.gov ID
- NCT05359770
- Acronym / sponsor ID
- FUniversity of Paraíba
- Keywords
- Transcranial direct current stimulation, Non-invasive brain stimulation, Inspiratory muscle training, Functional capacity, Maximal inspiratory pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Suellen Marinho AndradeUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 20 Dec 2022 (estimated)
- First posted
- 4 May 2022 (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.
COVID-19 is an infectious disease which presents a heterogenous clinical presentation. Recent investigations suggest that people who were infected by COVID-19 often develop physical disabilities (i.e. pain, fatigue), neurological complications and and mainly disorders of the respiratory system, such as respiratory muscle weakness after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation (tDCS) have been proposed to minimize functional and structural impairments. The aim of the present study is to evaluate the effects of inspiratory muscle training associated with stimulation of the diaphragmatic motor cortex through hd-tdcs in post-COVID-19 patients on inspiratory muscle strength, pulmonary function, inflammatory levels and functional capacity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Active HD-tDCS, Device: Control groupExperimental: Experimental Group/ Active HD-tDCS Patients randomly enrolled in this group will receive 10 sessions of anodal HD-tDCS stimulation on cortical representation zone of left diaphragmatic motor cortex associated to respiratory training; for 20 minutes (each session) with a 2mA intensity. The electrical current will be delivered with a ramp-up time of 30 s, held at 3mA for 20 min, and then ramped down over 30 s. |
| Sham Comparator | Sham comparator | Device: Active HD-tDCS, Device: Control groupSham Comparator: Control Group / Sham Group In the sham condition, the device will provide a 30-second ramp-up followed immediately by a 30-second ramp down in HD-tDCS associated with inspiratory muscle training for 20 minutes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who had a medical diagnosis of COVID-19, clinically stable, able to respond to simple commands, able to walk for six minutes and who sign study consent form will be enrolled.
Key exclusion criteria (1 listed)
- Those who present associated neurological diseases, pregnant, users of psychoactive drugs, patients who have metallic implants, electronic devices, pacemakers, or epileptic patients will be excluded.
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 |
|---|---|---|
| Active HD-tDCSExperimental group: 10-sessions of anodal HD-tDCS ( tDCS 1x1, developed by Soterix Medical Inc.) associated to respiratory training; for 20 minutes (each session). It will be delivered a 3mA intensity electrical current accordingly 10/20 International System on cortical representation zone of left diaphragmatic motor cortex using HD-tDCS. | Device | Experimental, Sham Comparator |
| Control groupAlso: Sham controlSham Control: 10-sessions of anodal HD-tDCS( tDCS 1x1, developed by Soterix Medical Inc.) associated to respiratory training; for 20 minutes (each session) with a 3mA intensity. The device will provide a 30-second ramp-up followed immediately by a 30-second ramp down. | Device | Experimental, Sham Comparator |
Primary outcome
Maximal inspiratory pressure
Time frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Maximal inspiratory pressure response to inspiratory muscle training in association with diaphragmatic motor cortex neurostimulation
5 secondary outcomes
Functional capacity
Time frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Forced vital capacity (FVC), forced expiratory volume 1st second (FEV1) and peak expiratory flow (PEF) by spirometry
Time frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Inflammatory biomarkers
Time frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Body composition by bioelectrical impedance
Time frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Depression level with Hamilton Anxiety Rating Scale (score 0 to 58)
Time frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2022.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active HD-tDCS in people with Coronavirus and Inspiratory Muscle Training, run by Suellen Marinho Andrade at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Sep 2022. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (time frame: From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)). 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 2 Sep 2022.