The Safety and Effectiveness of Q Therapeutic System, Frequency-tuned Electromagnetic Field Treatment in Facilitating the Recovery of Patients With Chronic Stroke.

Обзор

This trial will test a promising new intervention to promote post-stroke neural reorganization and functional recovery. The overall aim is to identify a systematic, methodological approach to system fitting, training protocols, and optimization of collecting outcome measures. Aim 1: Assess the safety of using the Q Therapeutic (BQ 3.0) System, including in-clinic and at- extremity rehabilitation training for individuals with chronic stroke, as determined by the number of adverse events. Device deficiencies will also be recorded to detect operational reliability. Aim 2: Evaluate the effectiveness of the Q Therapeutic (BQ 3.0) System for individuals with chronic stroke in improving upper extremity function as determined by change in functional outcome measures after 3-month treatment, including in-clinic and at-home sessions.

Подробное описание

STUDY DESIGN:

* This is a prospective, single-arm, open-label, single-center clinical trial designed to evaluate the safety, feasibility, and efficacy of the Q Therapeutic (BQ 3.0) System in the management of chronic stroke patients. * While this trial is conducted as a single-center Investigator-Initiated Trial (IIT), additional sites have initiated comparable IITs following a similar trial design. These sites will adhere to the core aspects of the study, with a prospective intent to pool results across sites into a primary pooled analysis, following a formal statistical plan. * All enrolled participants will undergo treatment with the investigational device according to the defined study protocol. * Primarily, the trial will assess the system's impact on the upper extremity function through objective, validated clinical assessments. Secondary endpoints will evaluate additional functional and global disability, quality-of-life and safety outcomes. * As a single-arm study, all participants will serve as their own control, with baseline measurements collected prior to device intervention and compared to post-treatment outcomes.

Вмешательства

• Устройство Experimental (Q Therapeutic System (BQ 3.0)
  Device: 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.

Первичные конечные точки

• Mean change of FMA-UE score [Срок оценки: Baseline, 3 months after, and 6 months after start of interventions]

Вторичные конечные точки (1)

• Safety endpoints: Cumulative incidence of adverse events [Срок оценки: Initial consent to final study visit (6 months)]

Критерии участия

Критерии включения

• Be between ages 18-80
• Have an score between 22-50 (inclusive) of impaired limb on the Fugl-Meyer Assessment for the Upper Extremity (FMA-UE), as determined by study staff
• Have upper extremity function that is not changing much over time (as determined by study staff based on assessments I complete at screening and before treatment starts)
• Have stroke due to ischemia or to intracerebral hemorrhage • Be >6 months to 5 years from stroke onset
• Have a Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit
• Be able to sit with the investigational System for 40 consecutive minutes
• Be able to follow a 3-step command in English, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent
• Have the willingness to participate in physical exercises during study intervention sessions.
• Be sure of the availability of a relative, friend, or other non-hired caregiver to be able to assist during program sessions and study visits, as needed

Критерии исключения

• Be younger than 18 years old or older than 80
• Have implanted MR-incompatible devices or MR-incompatible retained objects (like shrapnel) or an implanted life-sustaining MR-compatible devices (such as a pacemaker or internal cardiac defibrillator)
• Have conditions other than stroke, such as:

A. Severe neglect impairment interfering with assessments or treatments. B. Severe depression, defined as GDS Score >10/15 C. 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.

D. Severe upper extremity spasticity, defined as presence of upper extremity contracture or modified Ashworth Scale score ≥3 in either biceps or chest muscles.

E. Pre-existing neurological condition (such as Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with my participation in the study and/or confound neurological or functional evaluation F. Unstable serious illness/condition (such as active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months. significant visual disturbances, pre-existing or resulting from the index stroke, that cannot be corrected and that would interfere significantly with my participation in the study and/or confoundneurological or functional evaluation

• Have alcohol abuse and/or drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial
• Had active participation in an arm rehabilitation program with a therapist in the 4 weeks prior to the screening visit
• Plan to have an arm rehabilitation program with a therapist between the screening visit and the assessment visit at 3-months
• Be an employee of Kessler Foundation
• Be a prisoner
• Be pregnant or breastfeeding or planning pregnancy during the study period.
• Have other conditions or circumstances that, in the opinion of the investigators, would affect the safety or effectiveness of the training in which I would participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07499310 · R-1296-25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗