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Behavioural Intervention
Pascal Device for Long COVID Syndrome
N/A
Recruiting
Led By David Putrino
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Experiencing PASC symptoms ≥ 6 months
Must not have
Serious immune/autoimmune diagnoses prior to SARS-CoV-2 infection
Any serious unstable medical or neurologic condition
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of treatment, 4 weeks
Summary
This trial aims to test if a new treatment at home can help patients with memory issues caused by post-acute sequelae of SARS-CoV-2 (PASC). They will study 30
Who is the study for?
This trial is for adults with cognitive issues after recovering from COVID, often called 'Long COVID'. Participants should have moderate to severe memory or thinking problems since their illness. The study excludes individuals who are currently using other cognitive therapies or devices, those with implanted electronic medical devices, and pregnant women.
What is being tested?
The trial is testing the Pascal device, which is a new technology aimed at improving brain function in Long COVID patients. Half of the participants will receive this active device while the other half will get a sham (inactive) device as a comparison over four weeks of treatment.
What are the potential side effects?
Since this is an early-stage study primarily looking at feasibility and safety, specific side effects aren't listed but may include discomfort or skin irritation from wearing the device. Any unexpected reactions related to the use of Pascal will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have had long COVID symptoms for 6 months or more.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a serious immune or autoimmune condition before getting COVID-19.
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I do not have any serious or unstable health conditions.
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I am currently on medication that affects my immune system.
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I have not had a severe head injury or stroke in the last year.
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I was diagnosed with ME/CFS before getting COVID-19.
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I have been diagnosed with Post-treatment Lyme Disease Syndrome.
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I have been reinfected with COVID-19 in the last 30 days or during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of treatment, 4 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of treatment, 4 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Proportion of Successfully Completed Treatments
Secondary study objectives
Clarity of instructions
Device comfort
Device ease of use
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active deviceExperimental Treatment1 Intervention
The active device will generate a low amplitude magnetic field. 20 participants will be randomized to this arm.
Group II: Sham devicePlacebo Group1 Intervention
The sham device will not generate a low amplitude magnetic field. 10 participants will be randomized to this arm.
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Who is running the clinical trial?
Humanity Neurotech Inc.UNKNOWN
Icahn School of Medicine at Mount SinaiLead Sponsor
914 Previous Clinical Trials
572,871 Total Patients Enrolled
David PutrinoPrincipal InvestigatorIcahn School of Medicine at Mount Sinai