COVID-19Phase 1/2NCT04808284

Neuromodulation in COVID-19 Patients

A Phase 1/2 study testing Transcranial direct-current stimulation in people with COVID-19, run by D'Or Institute for Research and Education at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: COVID-19
What is being tested?: Transcranial direct-current stimulation
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteBrazil
Study dates: 10 Aug 2021to 11 Oct 2021
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

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

Other trials in Brazil

About this study

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.

Conditions: COVID-19
Being tested: Transcranial direct-current stimulation, Sham Transcranial direct-current stimulation
Keywords: SARS-CoV-2, transcranial direct current stimulation (tDCS), executive function, depression, anxiety, autonomic nervous system, motor function
Medical subject headings: COVID-19, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial direct-current stimulationDevice
Also called Active Transcranial direct-current stimulation, tDCS
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.
Transcranial direct-current stimulationDevice
Also called Active Transcranial direct-current stimulation, tDCS
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.
Sham Transcranial direct-current stimulationDevice
Also called Sham TDCS
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.

Study groups in NCT04808284
Study group	Role	What they receive
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. Receives: 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. Receives: 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). Receives: Device: Sham Transcranial direct-current stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events related to treatment (safety)
Safety as assessed by incidence of adverse events by type, frequency, severity, and causality
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Functional Status Score for the intensive care unit (FSS-ICU) changes from pre-treatment to post-treatment
Measured: 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
Maximum distances reached by subject change from pre-treatment to post-treatment
Measured: 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
Beck Depression Inventory-II (BDI-II) score changes from pre-treatment to post-treatment
Measured: 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
Beck Anxiety Inventory (BAI) score changes from pre-treatment to post-treatment
Measured: pre-treatment (baseline), post-treatment (up to one hour after the end of the treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 202111 Oct 2021

First posted22 Mar 2021
Study start10 Aug 2021
Primary completion11 Oct 2021
Study completion11 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04808284
Sponsor's protocol ID: PRJ2007
Status last verified: Oct 2021
First submitted: 16 Mar 2021
Last updated: 14 Oct 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuromodulation in COVID-19 Patients
ClinicalTrials.gov ID: NCT04808284
Acronym / sponsor ID: PRJ2007
Conditions: COVID-19
Keywords: SARS-CoV-2, transcranial direct current stimulation (tDCS), executive function, depression, anxiety, autonomic nervous system, motor function
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: D'Or Institute for Research and EducationUniversity, hospital or other
Collaborators: Rio de Janeiro State Research Supporting Foundation (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Study start: 10 Aug 2021 (actual)
Primary completion: 11 Oct 2021 (actual)
Study completion: 11 Oct 2021 (actual)
First posted: 22 Mar 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
tDCS-SMA	Experimental	Device: Transcranial direct-current stimulationParticipants randomized to this arm will receive a single tDCS session delivered at 2mA to the supplementary motor area (SMA) for 30 minutes.
tDCS- DLPFC	Experimental	Device: Transcranial direct-current stimulationParticipants 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.
tDCS- SHAM	Sham comparator	Device: Sham Transcranial direct-current stimulationParticipants 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).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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).

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial direct-current stimulationAlso: Active Transcranial direct-current stimulation, tDCSA 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.	Device	tDCS-SMA
Transcranial direct-current stimulationAlso: Active Transcranial direct-current stimulation, tDCSA 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.	Device	tDCS- DLPFC
Sham Transcranial direct-current stimulationAlso: Sham TDCSA 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.	Device	tDCS- SHAM

Primary outcome

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
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
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
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
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
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

4 secondary outcomes

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)
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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fernanda F Tovar-Moll, PhD study director

D'Or Institute for Research and Education (IDOR)

Erika C Rodrigues, PhD principal investigator

D'Or Institute for Research and Education (IDOR)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Transcranial direct-current stimulation in people with COVID-19, run by D'Or Institute for Research and Education at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events related to treatment (safety) (time frame: post-treatment (up to one hour after the end of the treatment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04808284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.