Post-acute Sequelae SARS-CoV-2 Infection (PASC)NCT05589272
TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms
A study testing Active tDCS in people with Post-acute Sequelae SARS-CoV-2 Infection (PASC), run by University of Minnesota at 1 site in United States.
Trial summary
The overarching goals of this study are to employ cognitive testing to understand how transcranial direct current stimulation (tDCS), when used concurrently with cognitive training tasks, can affect cognitive impairment symptoms in individuals with long COVID, or post-acute sequelae SARS-CoV-2 infection (PASC), and to… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post-acute Sequelae SARS-CoV-2 Infection (PASC)
- What is being tested?
- Active tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 1 Sep 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to provide consent and comply with study procedures
- Age 18 to 60 years old
- Estimated IQ within the specified range (70 \<= IQ E \<= 115)
- Current post-acute sequelae SARS-CoV-2 infection (PASC) as defined by the National Center for Health Statistics post-COVID-19 conditions survey ((Long COVID 2022), including impaired cognition symptoms, for at least 3 months post-infection
- Ability to participate in four weekly 40' training sessions over four weeks and participate in two assessments
- English speaking
Who cannot join
- Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness \>30 min, concussion involving hospital admission, HIV)
- Contraindications for tDCS (e.g. history of seizures)
- Five or more sessions of neuromodulation (such as tDCS) or cognitive training in the past 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The overarching goals of this study are to employ cognitive testing to understand how transcranial direct current stimulation (tDCS), when used concurrently with cognitive training tasks, can affect cognitive impairment symptoms in individuals with long COVID, or post-acute sequelae SARS-CoV-2 infection (PASC), and to examine variability in response between active and sham tDCS treatment groups.
- Being tested
- Active tDCS, Sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCSOther
cognitive training + active-tDCS tDCS twice a day (two 13 minute sessions per day, each 2mA / 25cm² = 0.08 current density; anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for five consecutive days.
Sham tDCSOther
cognitive training + sham-tDCS tDCS twice a day (two 13 minute sessions per day, each 2mA / 25cm² = 0.08 current density; anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for five consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training + active-tDCS | Experimental | Cognitive training + active-tDCS 4 times per week (20 minutes per session, each (~25cm²; current density = 0.08 mA/cm²); anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for four weeks. Receives: Other: Active tDCS |
| Cognitive training + sham-tDCS | Sham comparator | Cognitive training + sham-tDCS 4 times per week (20 minutes per session, each ~25cm²; current density = 0.08 mA/cm²); anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for four weeks. Receives: Other: Sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive improvement effects of WM training with active tDCS vs. sham
shown by WM task progression and performance on cognitive testing measures
Measured: baseline and post-test assessment, 4 weeks
Generalization of cognitive effects of active tDCS vs. sham
includes effect on PASC-related cognitive impairment symptoms
Measured: baseline and post-test assessment, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start1 Feb 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Why it stopped: Didn't receive IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-acute Sequelae SARS-CoV-2 Infection (PASC)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05589272
- Sponsor's protocol ID
- 30319 protocol
- Status last verified
- Mar 2023
- First submitted
- 19 Oct 2022
- Last updated
- 13 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TDCS-potentiated Generalization of Cognitive Training in the Rehabilitation of Long COVID Symptoms
- ClinicalTrials.gov ID
- NCT05589272
- Acronym / sponsor ID
- 30319 protocol
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Didn't receive IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 21 Oct 2022 (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 overarching goals of this study are to employ cognitive testing to understand how transcranial direct current stimulation (tDCS), when used concurrently with cognitive training tasks, can affect cognitive impairment symptoms in individuals with long COVID, or post-acute sequelae SARS-CoV-2 infection (PASC), and to examine variability in response between active and sham tDCS treatment groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training + active-tDCS | Experimental | Other: Active tDCSCognitive training + active-tDCS 4 times per week (20 minutes per session, each (~25cm²; current density = 0.08 mA/cm²); anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for four weeks. |
| Cognitive training + sham-tDCS | Sham comparator | Other: Sham tDCSCognitive training + sham-tDCS 4 times per week (20 minutes per session, each ~25cm²; current density = 0.08 mA/cm²); anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for four weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Ability to provide consent and comply with study procedures
- Age 18 to 60 years old
- Estimated IQ within the specified range (70 \<= IQ E \<= 115)
- Current post-acute sequelae SARS-CoV-2 infection (PASC) as defined by the National Center for Health Statistics post-COVID-19 conditions survey ((Long COVID 2022), including impaired cognition symptoms, for at least 3 months post-infection
- Ability to participate in four weekly 40' training sessions over four weeks and participate in two assessments
Key exclusion criteria (3 listed)
- Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness \>30 min, concussion involving hospital admission, HIV)
- Contraindications for tDCS (e.g. history of seizures)
- Five or more sessions of neuromodulation (such as tDCS) or cognitive training in the past 6 months
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 tDCScognitive training + active-tDCS tDCS twice a day (two 13 minute sessions per day, each 2mA / 25cm² = 0.08 current density; anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for five consecutive days. | Other | Cognitive training + active-tDCS |
| Sham tDCScognitive training + sham-tDCS tDCS twice a day (two 13 minute sessions per day, each 2mA / 25cm² = 0.08 current density; anode on left dorsolateral prefrontal cortex F3, cathode on right dorsolateral prefrontal cortex F4) for five consecutive days. | Other | Cognitive training + sham-tDCS |
Primary outcome
Cognitive improvement effects of WM training with active tDCS vs. sham
Time frame: baseline and post-test assessment, 4 weeks
shown by WM task progression and performance on cognitive testing measures
Generalization of cognitive effects of active tDCS vs. sham
Time frame: baseline and post-test assessment, 4 weeks
includes effect on PASC-related cognitive impairment symptoms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
Related trials for Post-acute Sequelae SARS-CoV-2 Infection (PASC)
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Neuropsychiatric Post-Acute Sequelae of SARS-CoV-2 Infection
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 tDCS in people with Post-acute Sequelae SARS-CoV-2 Infection (PASC), run by University of Minnesota at 1 site in United States.
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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Mar 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Cognitive improvement effects of WM training with active tDCS vs. sham (time frame: baseline and post-test assessment, 4 weeks). The study lists 2 primary outcomes in all. 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 13 Mar 2023.