Clinical trial NCT04808284: Neuromodulation in COVID-19 Patients
Official title: Neuromodulation in COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: COVID-19
Keywords: SARS-CoV-2
transcranial direct current stimulation (tDCS)
executive function
depression
anxiety
autonomic nervous system
motor function
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2021-03-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study is aimed at investigating the effects of transcranial direct current stimulation (tDCS) on COVID-19 patients not admitted to the intensive care unit. The tDCS is a non-invasive brain stimulation technique which applies a low intensity electrical current in order to modulate neuronal activity. Patients included will be submitted to a single session with active or sham tDCS, aiming to modulate prefrontal or supplementary motor area (SMA). Evaluation protocol will be performed before and after stimulation to verify the incidence of adverse events related to treatment and whether tDCS would affect measures of executive functioning, mood, anxiety, autonomic response and motor function in COVID-19 patients. We hypothesize the neuromodulation would be a safety, promising treatment to reduce possible impairments in COVID-19 patients.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Incidence of adverse events related to treatment (safety)
timeFrame: post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline autonomic response at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline Trial Making Test (TMT) score at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline Digit span score at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline balance parameters at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline gait parameters at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Secondary outcomes:
measure: Change from baseline Functional Status Score for the intensive care unit (FSS-ICU) at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline Functional Reach Test (FRT) distances at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline Beck Depression Inventory-II (BDI-II) score at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
measure: Change from baseline Beck Anxiety Inventory (BAI) score at the end of the treatment
timeFrame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: D'Or Institute for Research and Education (IDOR)
state: RJ
Study officials:
affiliation: D'Or Institute for Research and Education (IDOR)
name: Fernanda F Tovar-Moll, PhD
role: STUDY_DIRECTOR
affiliation: D'Or Institute for Research and Education (IDOR)
name: Erika C Rodrigues, PhD
role: PRINCIPAL_INVESTIGATOR
References: