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Completed

NCT Number: NCT04808284

Neuromodulation in COVID-19 Patients

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.

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Key information

Conditions

COVID-19 Anxiety Disorders Behavior Behavioral Symptoms Coronaviridae Infections Coronavirus Infections Depression Infections Lung Diseases Mental Disorders Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

D'Or Institute for Research and Education (IDOR)

Rio de Janeiro, 22.281-100, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transcranial direct-current stimulation

Device

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.

Other names: Active Transcranial direct-current stimulation, tDCS

Sham Transcranial direct-current stimulation

Device

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.

Other names: Sham TDCS

Primary outcomes

  1. Incidence of adverse events related to treatment (safety)

    Time frame: 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

  2. Change from baseline autonomic response at the end of the treatment

    Time frame: 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

  3. Change from baseline Trial Making Test (TMT) score at the end of the treatment

    Time frame: 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

  4. Change from baseline Digit span score at the end of the treatment

    Time frame: 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

  5. Change from baseline balance parameters at the end of the treatment

    Time frame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)

    Balance parameters change from pre-treatment to post-treatment

  6. Change from baseline gait parameters at the end of the treatment

    Time frame: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)

    Gait parameters change from pre-treatment to post-treatment

Secondary outcomes

  1. Change from baseline Functional Status Score for the intensive care unit (FSS-ICU) at the end of the treatment

    Time frame: 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

  2. Change from baseline Functional Reach Test (FRT) distances at the end of the treatment

    Time frame: 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

  3. Change from baseline Beck Depression Inventory-II (BDI-II) score at the end of the treatment

    Time frame: 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

  4. Change from baseline Beck Anxiety Inventory (BAI) score at the end of the treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

D'Or Institute for Research and Education

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 22, 2021
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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