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Humanity Neurotech Device Clinical Trial in Adults With Long COVID Cognitive Dysfunction

NCT06739668 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-02

No results posted yet for this study

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. 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.

Conditions

  • Post-Acute COVID-19 Syndrome
  • Cognitive Dysfunction

Interventions

DEVICE

Pascal device

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.

DEVICE

Sham Device

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.

Sponsors & Collaborators

Principal Investigators

  • David Putrino · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2025-12-01
Completion
2025-12-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06739668 on ClinicalTrials.gov