COVID-19COVID-19NCT05963958
HD-Tdcs and Pharmacological Intervention For Delirium In Critical Patients With COVID-19
A study testing Active HD-tDCS in people with COVID-19 and Delirium, run by Suellen Andrade at 1 site in Brazil.
Trial summary
The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19, Delirium, Critical Illness
- What is being tested?
- Active HD-tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Apr 2021to 30 Jan 2023
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years,
- confirmed clinical diagnosis for SARS-CoV-2,
- delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators
Who cannot join
- severe psychiatric illness that is not well controlled;
- pregnancy or active lactation,
- refusal of consent
- contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy, dermatitis at the site of stimulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19
The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS combined with concomitant dexmedetomidine would reduce delirium rates.
- Conditions
- COVID-19, Delirium, Critical Illness
- Being tested
- Active HD-tDCS, Sham HD-tDCS
- Medical subject headings
- COVID-19, Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active HD-tDCSCombination product
Brain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
Sham HD-tDCSCombination product
Sham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19
| Study group | Role | What they receive |
|---|---|---|
| Active HD-tDCS | Experimental | HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For each participant, a 3-mA current is applied via a center anode. The electric current was supplied to the active group and presented an acceleration time of 30 s, maintained at 3 mA for 30 min and then reduced for 30 s. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour). Receives: Combination Product: Active HD-tDCS |
| Sham HD-tDCS | Placebo comparator | HD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For the simulated condition, the investigators maintained the same 30-second acceleration up to a total of 3 mA, followed immediately by a 30-second deceleration. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour). Receives: Combination Product: Sham HD-tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Severity
delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.
Measured: 28 days
Secondary outcomes (5)
length of stay in the ICU and hospital stay
defined as the total number of days that patients remained in the hospital from the date of randomization to the date of hospital discharge
Measured: 28 days
Occurrence of hypotension requiring any vasopressor administration
Measured: 28 days
C-reactive protein levels
Measured: 28 days
ventilator-free days during the first 28 days
defined as the number of days free from mechanical ventilation for at least 48 consecutive hours
Measured: 28 days
Exploratory analisys
Organ dysfunction and clinical response; use of Concomitant Medications; Richmond Agitation Sedation Scale (RASS) and mortality prognosis
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start14 Apr 2021
- Primary completion2 Dec 2022
- Study completion30 Jan 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suellen Andrade
- Sponsor type
- University, hospital or other
- Collaborators
- City University of New York
- Responsible party
- Sponsor-investigator, Suellen Andrade, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963958
- Sponsor's protocol ID
- Delirium/HD-tDCS
- Acronym
- COVID-19
- Status last verified
- Jul 2023
- First submitted
- 1 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HD-Tdcs Associated With The Use Of Dexmedetomidine For Delirium In Critical Patients With Covid-19
- ClinicalTrials.gov ID
- NCT05963958
- Acronym / sponsor ID
- COVID-19 / Delirium/HD-tDCS
- Conditions
- COVID-19, Delirium, Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Suellen AndradeUniversity, hospital or other
- Collaborators
- City University of New York
- Study start
- 14 Apr 2021 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 27 Jul 2023 (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.
The goal of this clinical trial Is conducted to evaluate the efficacy and safety of active or sham HD-tDCS in combination with dexmedetomidine in patients with moderate to severe ARDS due to COVID-19 with delirium in intensive care unit (ICU). The hypothesis was that HD-tDCS combined with concomitant dexmedetomidine would reduce delirium rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active HD-tDCS | Experimental | Combination Product: Active HD-tDCSHD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For each participant, a 3-mA current is applied via a center anode. The electric current was supplied to the active group and presented an acceleration time of 30 s, maintained at 3 mA for 30 min and then reduced for 30 s. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour). |
| Sham HD-tDCS | Placebo comparator | Combination Product: Sham HD-tDCSHD-tDCS is delivered on 10 consecutive weekdays, with two sessions per day (in the morning and in the afternoon). For the simulated condition, the investigators maintained the same 30-second acceleration up to a total of 3 mA, followed immediately by a 30-second deceleration. And a maintenance dosage of dexmedetomidine (0.2 - 0.7 mcg/kg per hour). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years,
- confirmed clinical diagnosis for SARS-CoV-2,
- delirium confirmed through the CAM-ICU-7 test, applied by trained evaluators
Key exclusion criteria (4 listed)
- severe psychiatric illness that is not well controlled;
- pregnancy or active lactation,
- refusal of consent
- contraindications for brain stimulation such as: aneurysm clips, pacemaker, epilepsy, dermatitis at the site of stimulation
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 |
|---|---|---|
| Active HD-tDCSBrain stimulation using active high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19 | Combination product | Active HD-tDCS |
| Sham HD-tDCSSham high definition transcranial direct current stimulation is applied simultaneously with the use of dexmedetomidine as a pharmacological treatment for delirium in critical illness patients with covid-19 | Combination product | Sham HD-tDCS |
Primary outcome
Delirium Severity
Time frame: 28 days
delirium severity over the 28-day study period is measured using the CAM-ICU-7. Patients discharged before 28 days were considered without delirium.
5 secondary outcomes
length of stay in the ICU and hospital stay
Time frame: 28 days
Occurrence of hypotension requiring any vasopressor administration
Time frame: 28 days
C-reactive protein levels
Time frame: 28 days
ventilator-free days during the first 28 days
Time frame: 28 days
Exploratory analisys
Time frame: 28 days
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 27 Jul 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active HD-tDCS in people with COVID-19 and Delirium, run by Suellen Andrade 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 4 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 27 Jul 2023. 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.
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?
Delirium Severity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2023.