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Neuromodulation in COVID-19 Patients

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Transcranial direct-current stimulation
Transcranial direct-current stimulation
Sham Transcranial direct-current stimulation
Sponsored by
D'Or Institute for Research and Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring SARS-CoV-2, transcranial direct current stimulation (tDCS), executive function, depression, anxiety, autonomic nervous system, motor function

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • D'Or Institute for Research and Education (IDOR)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

tDCS-SMA

tDCS- DLPFC

tDCS- SHAM

Arm Description

Participants randomized to this arm will receive a single tDCS session delivered at 2mA to the supplementary motor area (SMA) for 30 minutes.

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.

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).

Outcomes

Primary Outcome Measures

Incidence of adverse events related to treatment (safety)
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
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
Trial Making Test (TMT) score changes from pre-treatment to post-treatment
Change from baseline Digit span score at the end of the treatment
Digit span score changes from pre-treatment to post-treatment
Change from baseline balance parameters at the end of the treatment
Balance parameters change from pre-treatment to post-treatment
Change from baseline gait parameters at the end of the treatment
Gait parameters change from pre-treatment to post-treatment

Secondary Outcome Measures

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
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
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
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

Full Information

First Posted
March 16, 2021
Last Updated
October 13, 2021
Sponsor
D'Or Institute for Research and Education
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
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1. Study Identification

Unique Protocol Identification Number
NCT04808284
Brief Title
Neuromodulation in COVID-19 Patients
Official Title
Neuromodulation in COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
October 11, 2021 (Actual)
Study Completion Date
October 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
D'Or Institute for Research and Education
Collaborators
Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
SARS-CoV-2, transcranial direct current stimulation (tDCS), executive function, depression, anxiety, autonomic nervous system, motor function

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS-SMA
Arm Type
Experimental
Arm Description
Participants randomized to this arm will receive a single tDCS session delivered at 2mA to the supplementary motor area (SMA) for 30 minutes.
Arm Title
tDCS- DLPFC
Arm Type
Experimental
Arm Description
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.
Arm Title
tDCS- SHAM
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Transcranial direct-current stimulation
Other Intervention Name(s)
Active Transcranial direct-current stimulation, tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct-current stimulation
Other Intervention Name(s)
Active Transcranial direct-current stimulation, tDCS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial direct-current stimulation
Other Intervention Name(s)
Sham TDCS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of adverse events related to treatment (safety)
Description
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Time Frame
post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline autonomic response at the end of the treatment
Description
Heart rate variability (HRV) parameters change from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline Trial Making Test (TMT) score at the end of the treatment
Description
Trial Making Test (TMT) score changes from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline Digit span score at the end of the treatment
Description
Digit span score changes from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline balance parameters at the end of the treatment
Description
Balance parameters change from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline gait parameters at the end of the treatment
Description
Gait parameters change from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Secondary Outcome Measure Information:
Title
Change from baseline Functional Status Score for the intensive care unit (FSS-ICU) at the end of the treatment
Description
Functional Status Score for the intensive care unit (FSS-ICU) changes from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline Functional Reach Test (FRT) distances at the end of the treatment
Description
Maximum distances reached by subject change from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline Beck Depression Inventory-II (BDI-II) score at the end of the treatment
Description
Beck Depression Inventory-II (BDI-II) score changes from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)
Title
Change from baseline Beck Anxiety Inventory (BAI) score at the end of the treatment
Description
Beck Anxiety Inventory (BAI) score changes from pre-treatment to post-treatment
Time Frame
pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernanda F Tovar-Moll, PhD
Organizational Affiliation
D'Or Institute for Research and Education (IDOR)
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erika C Rodrigues, PhD
Organizational Affiliation
D'Or Institute for Research and Education (IDOR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
D'Or Institute for Research and Education (IDOR)
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
22.281-100
Country
Brazil

12. IPD Sharing Statement

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Neuromodulation in COVID-19 Patients

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