Neuromodulation in COVID-19 Patients

COVID-19 Clinical Trial

Official title:

Neuromodulation in COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04808284
• Other study ID #: PRJ2007
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 10, 2021
• Est. completion date: October 11, 2021

Study information

• Verified date: October 2021
• Source: D'Or Institute for Research and Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 11, 2021
• Est. primary completion date: October 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Device:
• Transcranial direct-current stimulation
A single tDCS session will be delivered to the supplementary motor area (SMA) by a DC stimulator (NeuroConn, Germany). During stimulation, a pair of saline-soaked sponge electrodes (surface 35 cm²) will be used, with one electrode (anode) placed 1,8 cm forward Cz and the other electrode (cathode) over the right supraorbital region, according to the International 10-20 EEG system. Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 minutes current intensity will be ramp down for 30 seconds.
• Transcranial direct-current stimulation
A single tDCS session will be applied bilaterally over the dorsolateral prefrontal cortex (DLPFC) by a DC stimulator (NeuroConn, Germany). During stimulation, a pair of saline-soaked sponge electrodes (surface 35 cm²) will be placed over F3 (anode) and F4 (cathode), according to the International 10-20 EEG system. Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 minutes current intensity will be ramp down for 30 seconds.
• Sham Transcranial direct-current stimulation
A single Sham-tDCS session will be applied bilaterally over the dorsolateral prefrontal cortex (DLPFC) or over the supplementary motor area (SMA) by a DC stimulator (NeuroConn, Germany). A pair of saline-soaked sponge electrodes (surface 35 cm²) will be placed according to the International 10-20 EEG system. For SMA , one electrode (anode) will be placed 1,8 cm forward Cz and the other electrode (cathode) over the right supraorbital region. For DLPFC, electrodes will be placed over F3 (anode) and F4 (cathode). Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 seconds current intensity will be ramp down for 15 seconds.

Locations

Country	Name	City	State
Brazil	D'Or Institute for Research and Education (IDOR)	Rio de Janeiro	RJ

Sponsors (4)

Lead Sponsor	Collaborator
D'Or Institute for Research and Education	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events related to treatment (safety)	Safety as assessed by incidence of adverse events by type, frequency, severity, and causality	post-treatment (up to one hour after the end of the treatment)
Primary	Change from baseline autonomic response at the end of the treatment	Heart rate variability (HRV) parameters change from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Primary	Change from baseline Trial Making Test (TMT) score at the end of the treatment	Trial Making Test (TMT) score changes from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Primary	Change from baseline Digit span score at the end of the treatment	Digit span score changes from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Primary	Change from baseline balance parameters at the end of the treatment	Balance parameters change from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Primary	Change from baseline gait parameters at the end of the treatment	Gait parameters change from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Secondary	Change from baseline Functional Status Score for the intensive care unit (FSS-ICU) at the end of the treatment	Functional Status Score for the intensive care unit (FSS-ICU) changes from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Secondary	Change from baseline Functional Reach Test (FRT) distances at the end of the treatment	Maximum distances reached by subject change from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Secondary	Change from baseline Beck Depression Inventory-II (BDI-II) score at the end of the treatment	Beck Depression Inventory-II (BDI-II) score changes from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Secondary	Change from baseline Beck Anxiety Inventory (BAI) score at the end of the treatment	Beck Anxiety Inventory (BAI) score changes from pre-treatment to post-treatment	pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)