NCT06739668

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

Microtesla Magnetic Therapy (MMT) Treatment of Post-acute Sequelae of SARS CoV-2 (PASC): Controlled Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-12-19
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-12-18
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study