Recruiting

Electromagnetic Field

Sponsor:

BrainQ Technologies Ltd.

Code:

NCT06386874

Conditions

Ischemic Stroke

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Interventions

Q Therapeutic System (BQ 3.0) - Sham

Q Therapeutic System (BQ 3.0) - Active

Study Details

Brief summary:

This is a multicenter study that will be conducted at approximately 20 centers and up to 30 centers, if the sample size will be increased following interim assessment.

The Q Therapeutic System (BQ 3.0) 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.

The Q Therapeutic System (BQ 3.0) is indicated for adjunctive use in a clinical facility or home setting, in addition to standard-of-care therapies.

  • In Stage 1 (starting 4-21 days after the index stroke event to day 90 post stroke), participants will be randomly assigned (1:1) to receive either active or the sham treatments, up to 5 times a week, and at least to a total of 45 treatments.
  • In Stage 2 (day 90 to day 180 post stroke), participants in both the active and the control group will be allowed to continue to receive active treatments, up to 5 times per week.
  • In stage 3 (day 180 to day 270 post stroke), participants will not receive any treatments and would be followed up until the final visit at day 270.

Each session will last approximately 60 minutes, with stimulation activated for up to 40 minutes, in conjunction with a home-based exercise program. Treatments may be administered in the hospital, in the clinic or in a home setting.

The study will enroll 100-122 adult subjects who will be randomly assigned (1:1 allocation ratio) to either active or sham study intervention using the BQ 3.0 system.

Conditions

Ischemic Stroke

Study ID

NCT06386874

Start date

Aug 20, 2024

Status verified date

Nov, 2024

Completion date

Oct, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. mRS score of 3 or 4.
2. FMA-UE score between 10-45 (inclusive) of impaired limb.
3. SAFE score >0.
4. Age 22 to 80 years of age (inclusive).
5. Diagnosed with an ischemic stroke, confirmed by CT4 or MRI5 imaging.
6. First ever ischemic stroke, or a recurring ischemic stroke6 occurring at least 3 months after the previous stroke (any stroke), without residual neurological impairment or disability before current stroke.
7. Four to 21 days from stroke onset (or last known well).
8. Pre-stroke mRS of 0.
9. Able to sit with the investigational device for 40 consecutive minutes, in the opinion of the investigator or designee.
10. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me".
11. Willingness to participate in an exercise activity during study intervention sessions.
12. Availability of a relative or other caregiver able to assist in operating an application installed on a mobile device, including a video call, and assist the participant with the exercising program.
13. If female, not pregnant (as confirmed by a urine or a blood test, or as determined by an official medical document) or breastfeeding and with no ability to become pregnant or on an acceptable method of contraception during the study
14. Informed consent signed by subject.

Exclusion Criteria:

1. Hemineglect impairment (NIHSS item 11, score >0).
2. Implanted active electronic or passive MR-incompatible devices.
3. Pre-existing major neurological condition (eg, Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or pre-existing physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
4. Active epilepsy or currently taking anti-epileptic medication (indicated for the treatment of a seizure disorder), or any epileptic seizure in the last 5 years
5. Significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
6. Unstable serious illness/condition (eg, active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
7. A known severe allergic reaction to acrylic-based adhesives.
8. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
9. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
10. Employee of the Sponsor.
11. Prisoner.

Study Design

Enrollment

122 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

sham comparator: BQ 3.0 Sham Stimulation Group

Q Therapeutic System (BQ 3.0) sham stimulation group:

Device used: Q Therapeutic System (BQ 3.0)

In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of sham study intervention with BQ 3.0 (frequency and intensity parameters will be set to zero so that no stimulation is delivered) including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.

active comparator: BQ 3.0 Active Stimulation Group

Q Therapeutic System (BQ 3.0) active stimulation group:

Device used: Q Therapeutic System (BQ 3.0)

In Stage 1: 45 sessions over a period of 9 weeks (5 treatments per week) of active study intervention with the BQ 3.0 (frequency and intensity parameters will be set to 1-100 Hz.; 0.1-1.0 G), including a standardized, pre-defined and evidence-based physical and occupational therapy regimen concurrent with the study intervention.

Interventions

Q Therapeutic System (BQ 3.0) - Sham

The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery. Frequency and intensity parameters will be set to zero so that no stimulation is delivered.

Q Therapeutic System (BQ 3.0) - Active

The BQ 3.0 is a medical device that produces and delivers non-invasive, extremely low intensity and frequency (1-100 Hz.; 0.1-1.0 G), frequency tuned electromagnetic fields in order to stimulate neuronal networks with the aim of reducing disability and promoting neurorecovery

Primary outcome measure

  • Change from Baseline in Modified Rankin Scale [ Time Frame: 4 to 21 days following an ischemic stroke to 90-day post-stroke ]

Central Contacts and Locations

Locations

Rancho Research Institute

Recruiting

Downey, California, United States, 90242

Contacts

MedStar National Rehabililtaion Hospital,

Recruiting

Washington, District of Columbia, United States, 20010

Contacts

KUMC- KU Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Hackensack Meridian JFK Johnson Rehabilitation Institute

Recruiting

Edison, New Jersey, United States, 08818

Contacts

Kessler Foundation for Rehabilitation

Recruiting

West Orange, New Jersey, United States, 07052

Contacts

Burke Rehabilitation Hospital

Recruiting

White Plains, New York, United States, 10605

Contacts

Atrium Health Carolinas Rehabilitation

Recruiting

Charlotte, North Carolina, United States, 28203

Contacts

More Information

Sponsor

BrainQ Technologies Ltd.

Last update posted

Jan 9, 2025

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BrainQ Technologies Ltd. on 2025-01-09.