NCT04808284

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_1 covid19

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 16, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

August 10, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

March 16, 2021

Last Update Submit

October 13, 2021

Conditions

COVID-19

Keywords

SARS-CoV-2transcranial direct current stimulation (tDCS)executive functiondepressionanxietyautonomic nervous systemmotor function

Outcome Measures

Primary Outcomes (6)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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 Outcomes (4)

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

    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

    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

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

Study Arms (3)

tDCS-SMA

EXPERIMENTAL

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

tDCS- DLPFC

EXPERIMENTAL

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

tDCS- SHAM

SHAM COMPARATOR

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

Interventions

Transcranial direct-current stimulationDEVICE

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.

Also known as: Active Transcranial direct-current stimulation, tDCS
tDCS-SMA
Sham Transcranial direct-current stimulationDEVICE

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.

Also known as: Sham TDCS
tDCS- SHAM

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

D'Or Institute for Research and Education (IDOR)

Rio de Janeiro, Rio de Janeiro, 22.281-100, Brazil

Location

MeSH Terms

Conditions

COVID-19DepressionAnxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesBehavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Fernanda F Tovar-Moll, PhD

    D'Or Institute for Research and Education (IDOR)

    STUDY DIRECTOR

  • Erika C Rodrigues, PhD

    D'Or Institute for Research and Education (IDOR)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2021

First Posted

March 22, 2021

Study Start

August 10, 2021

Primary Completion

October 11, 2021

Study Completion

October 11, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

BR(1)