Neuromodulation in COVID-19 Patients

Phase 1

Completed

• Conditions: COVID-19
• Interventions: Device: Sham Transcranial direct-current stimulation; Device: Transcranial direct-current stimulation

• Registration Number: NCT04808284
• Lead Sponsor: D'Or Institute for Research and Education

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-18
• Study First Posted: 2021-03-22
• Study Start: 2021-08-10
• Status Verified: 2021-10
• Primary Completion: 2021-10-11
• Study Completion: 2021-10-11
• Last Update Submitted: 2021-10-13
• Last Update Posted: 2021-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tDCS- SHAM	Sham Transcranial direct-current stimulation	Participants randomized to this arm will receive a single session of Sham tDCS for 30 minutes, delivered to supplementary motor area (SMA) or to the right (cathodal) and left (anodal) dorsolateral prefrontal cortex (DLPFC).
tDCS-SMA	Transcranial direct-current stimulation	Participants randomized to this arm will receive a single tDCS session delivered at 2mA to the supplementary motor area (SMA) for 30 minutes.
tDCS- DLPFC	Transcranial direct-current stimulation	Participants randomized to this arm will receive a single tDCS session delivered at 2mA to the right (cathodal) and left (anodal) dorsolateral prefrontal cortex (DLPFC) for 30 minutes.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events related to treatment (safety)	post-treatment (up to one hour after the end of the treatment)	Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Change from baseline autonomic response at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Heart rate variability (HRV) parameters change from pre-treatment to post-treatment
Change from baseline Trial Making Test (TMT) score at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Trial Making Test (TMT) score changes from pre-treatment to post-treatment
Change from baseline Digit span score at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Digit span score changes from pre-treatment to post-treatment
Change from baseline gait parameters at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Gait parameters change from pre-treatment to post-treatment
Change from baseline balance parameters at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Balance parameters change from pre-treatment to post-treatment

Secondary Outcome Measures

Name	Time	Method
Change from baseline Functional Status Score for the intensive care unit (FSS-ICU) at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Functional Status Score for the intensive care unit (FSS-ICU) changes from pre-treatment to post-treatment
Change from baseline Functional Reach Test (FRT) distances at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Maximum distances reached by subject change from pre-treatment to post-treatment
Change from baseline Beck Anxiety Inventory (BAI) score at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Beck Anxiety Inventory (BAI) score changes from pre-treatment to post-treatment
Change from baseline Beck Depression Inventory-II (BDI-II) score at the end of the treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)	Beck Depression Inventory-II (BDI-II) score changes from pre-treatment to post-treatment

Trial Locations

Locations (1)

D'Or Institute for Research and Education (IDOR); 🇧🇷 Rio de Janeiro, RJ, Brazil