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治験 NCT07095920（対象：脳卒中、Chronic Stroke Patients、脳血管障害 (CVA)）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。
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RESPARK - Brain Q for Chronic Stroke

募集中
治験(臨床試験)の詳細は主に英語で提供されています。しかし、治験レーダーAIが支援できます！「治験を説明」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07095920 は 介入研究 臨床試験 で、脳卒中、Chronic Stroke Patients、脳血管障害 (CVA) に関するものです。現在は 募集中 で、2025年8月27日 から開始しています。25 名の参加者 の募集が計画されています。この治験は フロリダ大学 によって主催され、2026年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年9月19日 です。
概要
This trial tests a promising new intervention to promote post-stroke neural reorganization and functional recovery. The Q Therapeutic (BQ 3.0) is a wearable medical system 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. This trial 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 rehabilitation of people with chronic stroke.
詳細説明
The study intervention will consist of a total of 5 sessions per week over a period of 3 months (12 weeks) for a total of up to 60 sessions. Each participant must complete at least 40 sessions over the 12-week period to complete the protocol. No extra time will be given to complete all 60 sessions. Each session will last up to 60 minutes during which 40 minutes of active stimulation using the BQ 3.0 System will be administered to participants. The 40 minutes of stimulation will be paired with seated upper extremity (UE) exercises. Lastly, the device will be removed and 10 minutes of standing balance and LE strengthening exercises will be performed without stimulation. A battery of clinical assessments will be conducted before and after the 60 exercise sessions.
公式タイトル

Frequency-tuned Electromagnetic Field Treatment to Facilitate Recovery of Patients With Chronic Stroke

疾患／病気
脳卒中Chronic Stroke Patients脳血管障害 (CVA)
その他の研究識別子
  • IRB202500526
NCT番号
NCT07095920
開始日
2025-08-27
最終更新日
2025-09-19
終了予定日
2026-12
目標参加者数
25
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
BrainQ
Electromagnetic Stimulation
upper extremity
rehabilitation
exercise
mobility
主目的
治療
割付方法
該当なし
介入モデル
単一群割当
盲検化
なし（非盲検）
群（アーム）／介入
参加グループ/群介入/治療法
実験的BQ3.0 Active Stimulation
60 sessions over a period of 12 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.
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.
主要評価項目
評価指標指標の説明時間枠
Change in Fugl-Meyer Assessment - Upper Extremity
A performance measure used to assess arm function. 33 items are scored on a scale of 0 to 2, where 0=cannot perform, 1=performs partially and 2=performs fully. An increase in score reflects an improvement in arm function.
Baseline, 3 months after, and 6 months after start of interventions
Change from Baseline in Modified Rankin Scale (mRS)
A 7-point scale used to measure the degree of disability or dependence in daily activities of people who have suffered a stroke. Scores range from 0 (no symptoms) to 6 (death). A decrease in score reflects a reduction in disability and improved independence.
Baseline, 3 months after, and 6 months after the start of interventions
副次評価項目
評価指標指標の説明時間枠
Cumulative incidence of adverse events
The number of adverse events reported throughout the study.
Initial consent through final study visit (6 months)
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  1. Upper Extremity Fugl-Meyer Assessment score between 22-50 (inclusive) of impaired limb.
  2. Upper Extremity Fugl-Meyer Assessment score is within up to 3-point difference between Screening and Baseline visit.
  3. Age 18 to 80 years of age (inclusive).
  4. Stroke due to ischemia or to intracerebral hemorrhage.
  5. >6 months to 5 years from stroke onset.
  6. Box & Block Test score with affected arm is ≥1 block in 60 seconds.
  7. Able to sit with the investigational system for 40 consecutive minutes.
  8. Can follow a 3-step command, such as "take the paper, fold it in half, and return it to me", or a non-verbal equivalent.
  9. Willingness to participate in physical exercises during study intervention sessions.
  10. Availability of a relative or other caregiver that is able to participate in training and assist during treatment sessions at Brooks and home during the study duration.
  11. If female, not pregnant or breastfeeding or planning pregnancy during the study period.
  12. The subject is able to provide Informed consent.

  1. Severe neglect impairment interfering with assessments or treatments.
  2. Severe depression, defined as Geriatric Depression Scale (GDS) Score >10/15
  3. Presence of implanted or retained MR-incompatible devices or materials, or the presence of life-sustaining MR-compatible devices (e.g. pacemaker or internal cardiac defibrillator).
  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. Botulinum toxin to the paretic arm: received in the prior 3 months OR expected before the 6-Month Visit
  6. Severe upper extremity spasticity, defined as presence of contracture or modified Ashworth Scale score ≥3 in either biceps or pectoralis
  7. Pre-existing neurological condition (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis, traumatic brain injury, spinal cord injury) or physical limitation that would interfere significantly with the subject's participation in the study and/or confound neurological or functional evaluation.
  8. 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.
  9. Unstable serious illness/condition (e.g., active cancer, severe heart failure, active major psychiatric condition) or life expectancy of less than 12 months.
  10. Alcohol abuse and/or illicit drug abuse in the past 6 months, which is likely to influence ability to fully participate in the trial.
  11. Participation in another trial that would conflict with the current study or clinical endpoint interference may occur.
  12. Active participation in an upper extremity rehabilitation program provided by a licensed provider within 4 weeks from the screening visit and until the primary endpoint visit.
  13. Employee of the Sponsor.
  14. Prisoner.
University of Florida logoフロリダ大学296 件のアクティブな治験を探索
  • BrainQ Technologies Ltd. logoBrainQ Technologies Ltd.
  • Brooks Rehabilitation logoBrooks Rehabilitation
試験中央連絡先
連絡先: Emily J Fox, PT, DPT, MHS, PhD, 904-742-2500, [email protected]
連絡先: Jennifer Brooke Hoisington, MSPT, 904-659-3733, [email protected]
1 1カ国の場所

Florida

Brooks Rehabilitation Clinical Research Center, Jacksonville, Florida, 32216, United States
Jennifer Brooke Hoisington, MSPT, 連絡先, 904-659-3733, [email protected]
Emily J Fox, PT, DPT, MHS, PhD, 研究責任者
募集中