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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05359770
Other study ID # FUniversity of Paraíba
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 22, 2021
Est. completion date December 20, 2022

Study information

Verified date September 2022
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 20, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Device:
Active HD-tDCS
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 group
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.

Locations

Country Name City State
Brazil Suellen Andrade, pHD João Pessoa Paraíba

Sponsors (1)

Lead Sponsor Collaborator
Suellen Marinho Andrade

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximal inspiratory pressure Maximal inspiratory pressure response to inspiratory muscle training in association with diaphragmatic motor cortex neurostimulation From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary 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. From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary 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 From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary Inflammatory biomarkers Correlate levels of inflammatory markers (interleukin-6 and C-reactive protein) with inspiratory muscle training and/or diaphragmatic motor cortex neurostimulation From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary 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 From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
Secondary 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. From date of randomization (2 weeks before intervention beginning) and up to 10 weeks (T1)
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