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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • 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

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
Intervention / Treatment
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

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

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

D'Or Institute for Research and Education

Collaborators

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

Investigators

  • 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)

August 10, 2021

Primary Completion (ACTUAL)

October 11, 2021

Study Completion (ACTUAL)

October 11, 2021

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (ACTUAL)

March 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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