Neuromodulation in COVID-19 Patients

October 13, 2021 updated by: D'Or Institute for Research and Education
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22.281-100
        • D'Or Institute for Research and Education (IDOR)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: tDCS-SMA
Participants randomized to this arm will receive a single tDCS session delivered at 2mA to the supplementary motor area (SMA) for 30 minutes.
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.
Other Names:
  • tDCS
  • Active Transcranial direct-current stimulation
Device: 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.
Other Names:
  • tDCS
  • Active Transcranial direct-current stimulation
EXPERIMENTAL: tDCS- DLPFC
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.
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.
Other Names:
  • tDCS
  • Active Transcranial direct-current stimulation
Device: 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.
Other Names:
  • tDCS
  • Active Transcranial direct-current stimulation
SHAM_COMPARATOR: tDCS- SHAM
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).
Device: 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.
Other Names:
  • Sham TDCS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
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
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
D'Or Institute for Research and Education

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Fernanda F Tovar-Moll, PhD, D'Or Institute for Research and Education (IDOR)
  • Principal Investigator: Erika C Rodrigues, PhD, D'Or Institute for Research and Education (IDOR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 10, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 16, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PRJ2007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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