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The Efficacy of a Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Subacute Ischemic Stroke Patients - a Pivotal Study (THE "EMAGINE" STUDY)

NCT05044507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-03-19

No results posted yet for this study

Summary

This is a multicenter study that will be conducted at approximately 20 centers. BQ 2.0 is a wearable medical device that produces and delivers non-invasive, extremely-low-intensity and low-frequency, frequency-tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery.

In this study, BQ 2.0 is intended to reduce disability in adult patients with subacute ischemic stroke, with a moderate to severe disability which includes an upper extremity motor impairment.

BQ 2.0 will be used for 9 weeks in conjunction with physical and occupational therapy (PT/OT) and periodic supervision (either remote or in person) of a trained site study team member. Treatments may be administered in multiple settings (e.g. acute care hospital (ACH) or inpatient rehabilitation facilities (IRF), Skilled Nursing Facility (SNF), home or other outpatient setup).

The study will enroll up to 150 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using BQ 2.0.

Conditions

Interventions

DEVICE

BQ 2.0

frequency and intensity parameters will be set to zero so that no stimulation is delivered

DEVICE

BQ 2.0

The BQ 2.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; up to 1 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery

Sponsors & Collaborators

  • BrainQ Technologies Ltd.

    lead INDUSTRY

Principal Investigators

  • Jeffrey L Saver, MD · Lead Coordinating PI

  • Pamela W Duncan, PhD · Lead Coordinating PI

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-04
Primary Completion
2023-11-06
Completion
2024-01-16
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05044507 on ClinicalTrials.gov