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| Column | Value |
|---|---|
| Trial registration number | NCT04808284 |
|
Full text link
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : Sept. 18, 2021, 5 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Sept. 18, 2021, 5 a.m. Source : ClinicalTrials.gov |
erika.rodrigues@idor.org |
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Registration date
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-03-22 |
|
Recruitment status
Last imported at : Oct. 16, 2021, 3 p.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
|
Study aim
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
inclusion criteria: - suspected or confirmed diagnosis for sars-cov-2; - ability to understand and execute the proposed protocol; - vital signs (body temperature <38ºc, blood pressure between 90 x 60mmhg and 140 x 90 mmhg, respiratory rate between 12 e 30 bpm). |
|
Exclusion criteria
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
- dyspnea or signs of respiratory effort; - spo2 ≤ 90%; - hemodynamic instability; - deep vein thrombosis, active bleeding, use of cardiac pacemaker; - injury, pain or metallic implants in the cranium or scalp; - seizure history; - suspected or confirmed pregnancy; - concomitant or previous rheumatic or neurological diseases; - severe psychiatric diseases (schizophrenia, bipolar disorder, intellectual disability); - severe musculoskeletal and/or integumentary disorders; - severe psychiatric disorders; - severe liver or kidney disease. |
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Number of arms
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
3 |
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Funding
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
D'Or Institute for Research and Education |
|
Inclusion age min
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
|
Inclusion age max
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
80 |
|
Countries
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Brazil |
|
Type of patients
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild disease at enrollment |
|
Severity scale
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
1: Mild disease at enrollment |
|
Total sample size
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
60 |
|
primary outcome
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Change from baseline autonomic response at the end of the treatment;Change from baseline balance parameters at the end of the treatment;Change from baseline Digit span score at the end of the treatment;Change from baseline gait parameters at the end of the treatment;Change from baseline Trial Making Test (TMT) score at the end of the treatment;Incidence of adverse events related to treatment (safety) |
|
Notes
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
|
Phase
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
|
Arms
Last imported at : March 25, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "supplementary motor area (SMA)", "treatment_id": 1310, "treatment_name": "Transcranial direct-current stimulation", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "dorsolateral prefrontal cortex (DLPFC) ", "treatment_id": 1310, "treatment_name": "Transcranial direct-current stimulation", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |