Post-Acute COVID-19 SyndromeNCT06739668
Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction
A study testing Pascal device in people with Post-Acute COVID-19 Syndrome and Cognitive Dysfunction, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Acute COVID-19 Syndrome, Cognitive Dysfunction
- What is being tested?
- Pascal device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 1 Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- English Speaking
- SARS CoV-2 infection as documented by laboratory nucleic acid amplification test or antibody test ≥ 6 months from screening or signed attestation of positive test result
- Experiencing PASC symptoms ≥ 6 months
- Objective cognitive impairment on neuropsychological measures (as defined by a z-score ≥1 standard deviation below the normative mean) in executive functioning
- Individuals of childbearing age agreeing to use a highly effective form of birth control
Who cannot join
- History of cognitive dysfunction present prior to SARS CoV-2 infection
- Febrile (> 99 F) at the time of the enrollment visit
- Enrollment in another interventional clinical trial in the last 90 days or during the study period
- Recent SARS CoV-2 reinfection in the last 30 days or during the study period
- Recent SARS CoV-2 vaccination in the last 30 days or plans to be vaccinated during the 8 week study period
- Currently taking immunomodulatory medication on an ongoing basis (NSAIDs, corticosteroids, cytokine antagonists, IVIG)
Show all 16Show fewer
- History of bipolar disorder, psychotic disorder, substance use disorder
- Change in anti-depressant or other psychoactive medication or dose in the last 90 days
- Cranially implanted devices or metal
- Any serious unstable medical or neurologic condition
- History of severe head injury (as defined by loss of consciousness for ≥30 minutes) or stroke in the past 12 months
- Pregnant or plan to become pregnant during the study as indicated by positive pregnancy test
- Serious immune/autoimmune diagnoses prior to SARS-CoV-2 infection
- ME/CFS diagnosis prior to first SARS-CoV-2 infection
- Existing diagnosis of Post-treatment Lyme Disease Syndrome
- Inability to achieve appropriate positioning of the study device on the head
Trial locations and contacts
1 site in 1 country.
United States1 site
The Cohen Center for Recovery from Complex Chronic Illnesses (CoRE)
New York, New York, 10029
About this study
Official title: Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study
The purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.
- Being tested
- Pascal device, Sham Device
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pascal deviceDevice
The study devices consist of a tabletop Console with user interface and a head-worn applicator (Headset) that is connected via coaxial cable. The Headset is positioned on the head per instructions, and then the study subject powers on the device by pressing the power button and initiates a 15-minute treatment by pressing the start button. LED lights on the console count down during the treatment to indicate time remaining and, once the treatment is complete, the device automatically powers off.
Sham DeviceDevice
The sham device will look identical to the active device and will have the same indicator lights and sounds, but will not emit magnetic field therapy.
| Study group | Role | What they receive |
|---|---|---|
| Active device | Experimental | The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm. Receives: Device: Pascal device |
| Sham device | Sham comparator | The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Successfully Completed Treatments
Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.
Measured: End of treatment, 4 weeks
Secondary outcomes (3)
Device comfort
Comfort will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater comfort.
Measured: End of treatment, 4 weeks
Device ease of use
Ease of use will be assessed using a 5-point Likert scale, full scale from 1-5 with higher scores indicating greater ease of use.
Measured: End of treatment, 4 weeks
Clarity of instructions
Clarity of instructions will be assessed using a 5-point Likert scale, full scale from 1-5 with high scores indicating greater clarity of instructions.
Measured: End of treatment, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start19 Dec 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization, 2:1, Active to Sham
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Humanity Neurotech Inc.
- Responsible party
- Principal investigator, David Putrino, Icahn School of Medicine at Mount Sinai
- Investigators
- David Putrino, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739668
- Sponsor's protocol ID
- STUDY-24-01276
- Status last verified
- Jan 2026
- First submitted
- 17 Dec 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT06739668
- Acronym / sponsor ID
- STUDY-24-01276
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Humanity Neurotech Inc.
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 18 Dec 2024 (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 purpose of this study is to assess the feasibility of an at-home MMT treatment in patients with cognitive dysfunction related to PASC, and to collect data on safety and efficacy to inform the design of larger clinical studies. A prospective randomized controlled study of 30 participants with PASC and moderate to severe cognitive dysfunction. Total study duration will be 8 weeks, including 4 weeks of treatment and 4 weeks of untreated follow up.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization, 2:1, Active to Sham
| Arm | Type | Receives |
|---|---|---|
| Active device | Experimental | Device: Pascal deviceThe active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm. |
| Sham device | Sham comparator | Device: Sham DeviceThe sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years of age or older
- English Speaking
- SARS CoV-2 infection as documented by laboratory nucleic acid amplification test or antibody test ≥ 6 months from screening or signed attestation of positive test result
- Experiencing PASC symptoms ≥ 6 months
- Objective cognitive impairment on neuropsychological measures (as defined by a z-score ≥1 standard deviation below the normative mean) in executive functioning
Key exclusion criteria (16 listed)
- History of cognitive dysfunction present prior to SARS CoV-2 infection
- Febrile (> 99 F) at the time of the enrollment visit
- Enrollment in another interventional clinical trial in the last 90 days or during the study period
- Recent SARS CoV-2 reinfection in the last 30 days or during the study period
- Recent SARS CoV-2 vaccination in the last 30 days or plans to be vaccinated during the 8 week study period
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 |
|---|---|---|
| Pascal deviceThe study devices consist of a tabletop Console with user interface and a head-worn applicator (Headset) that is connected via coaxial cable. The Headset is positioned on the head per instructions, and then the study subject powers on the device by pressing the power button and initiates a 15-minute treatment by pressing the start button. LED lights on the console count down during the treatment to indicate time remaining and, once the treatment is complete, the device automatically powers off. | Device | Active device |
| Sham DeviceThe sham device will look identical to the active device and will have the same indicator lights and sounds, but will not emit magnetic field therapy. | Device | Sham device |
Primary outcome
Proportion of Successfully Completed Treatments
Time frame: End of treatment, 4 weeks
Feasibility of using the device at home will be measured based upon the proportion of successfully completed treatments.
3 secondary outcomes
Device comfort
Time frame: End of treatment, 4 weeks
Device ease of use
Time frame: End of treatment, 4 weeks
Clarity of instructions
Time frame: End of treatment, 4 weeks
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 2 Feb 2026.
- Individual participant dataSharing planned: No. No plan to share IPD.
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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.
David Putrino principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pascal device in people with Post-Acute COVID-19 Syndrome and Cognitive Dysfunction, run by Icahn School of Medicine at Mount Sinai 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 16 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 2 Feb 2026. 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 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?
Proportion of Successfully Completed Treatments (time frame: End of treatment, 4 weeks). 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 2 Feb 2026.