Coronavirus, COVID-19 Respiratory Infection
Conditions
Keywords
COVID-19 Respiratory Infection, Transcranial direct current stimulation, Non-invasive brain stimulation, Electroencephalography, Long Covid
Brief 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) and neurological complications after hospital discharge. Many therapeutic approaches such as transcranial direct current stimulation high definition (HD-tDCS) have been proposed to minimize functional and structural impairments. Recently, I electroencephalogram (EEG) has been used as predictor of HD-tDCS effectiveness in diverse neurological populations. However, evidences about this tool utilization as efficacy predictor of tDCS in COVID-19 people rest inconclusive. Thereby, our objective is to evaluate HD-tDCS efficacy on fatigue, pain and functional capacity of patients with COVID-19 chronic.
Detailed description
We propose a sham-controlled randomized clinical trial with patients in COVID-19 chronic. They will be evaluated according to following eligibility 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. 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. Patients will be allocated randomly to the experimental group or sham control. Sessions for experimental group consist of anodal HD-tDCS on Left diaphragmatic primary motor cortex associated to respiratory training (10 sessions, 3mA, 20 minutes/session). In the sham condition, the device provided a 30-second ramp-up period to the full 3 mA, followed immediately by a 30-second ramp down. Patients will be assessed in three moments: pre-treatment, post-treatment and after 30 days treatment ending (follow-up).
Interventions
DEVICEExperimental group/ Active HD-tDCS
Patients enrolled in this group will received 20 minutes of anodal HD-tDCS ( tDCS 1x1, developed by Soterix Medical Inc.) during 10 sessions. 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.
DEVICEControl Group / Sham Group
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.
Sponsors
Federal University of Paraíba
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Impact | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | MFIS-BR is a tool composed by 21 items stratified into 3 domains |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Capacity | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | Functional capacity will be evaluated by Lawton and Brody scale and also by 6 minutes walking test. |
| Quality of Life | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | Quality of life will be measured through Brazilian version of World Health Organization Quality of Life. |
| Pulmonary Function | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | This outcome will be assessed through spirometry, assessment of maximal inspiratory pressure and respiratory endurance. |
| Pain Level | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | Pain level will be evaluated through McGill questionnaire. |
| Anxiety | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | Anxiety level will be evaluated through Hamilton Anxiety Rating Scale. |
| Depression | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | Depression will be assessed by Beck's Depression Inventory. |
| Self-efficacy | Self-efficacy will be assessed after intervention ending. | Self-efficacy will be evaluated through the Self-efficacy manage chronic disease 6-item scale. |
| Body Composition | From date of randomization (1 week before intervention beginning) up to 5 weeks (T1) and up to 10 weeks (T2; follow-up) | Body composition analysis will be carried out by bioelectrical impedance analysis. |
Countries
Brazil
Contacts
Primary ContactSuellen Andrade, Phd
Backup ContactKelly Santana
Outcome results
None listed