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临床试验 NCT07394608 针对脑瘫目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation 10 无创 青少年 开放性试验
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临床试验NCT07394608是一项针对脑瘫的干预性研究试验，目前试验状态为招募中。试验始于2026年4月1日，计划招募10名患者。该研究由Icahn School of Medicine at Mount Sinai主导，预计于2028年3月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月13日。
简要概括
This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy.
官方标题
Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial
疾病
脑瘫其他研究标识符
- STUDY-25-01164
主要目的
其他
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Non-invasive VNS Non-invasive, transauricular, vagus nerve stimulation device will be used during physical therapy rehabilitation sessions | Non-invasive taVNS Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE). |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of adverse event and serious adverse events | Safety is assessed by adverse event. | 12 months |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Number of therapy sessions complete | Number of therapy sessions complete | end of therapy visits at Day 46 |
Active training time per session | Number of minutes of training per session | end of therapy visits at Day 46 |
Number of movement repetitions completed per session | Number of movement repetitions completed per session. | end of therapy visits at Day 46 |
Jebsen Taylor Hand Function Test (JTHFT) | The Jebsen Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand functions that uses simulated activities of daily living (ADLs) assessed by time to completion; typically up to several minutes depending on impairment | baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months |
BOT-2 | The BOT-2 is a standardized assessment of motor proficiency in children and adolescents. It evaluates fine motor skills, manual dexterity, coordination, and motor integration through structured performance tasks.
Fine Motor Precision (Upper Extremity) scored 0-41, higher score indicates better precision Fine Motor Integration (Upper Extremity) scored 0-45, higher score indicates better integration Manual Dexterity (Upper Extremity) scored 0- 45, higher score indicates better manual dexterity.
Upper-Limb Coordination scored 0-30, higher score indicates better upper-limb coordination. | baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months |
ABILHANDS | ABILHAND is a patient-reported outcome measure that evaluates a person's perceived manual ability to perform daily bimanual activities. It assesses how difficult activities are to perform using both hands.
The ABILHAND-Kids logit score ranges from -6 logits to +6 logits, higher score indicates better bimanual manual ability (tasks are perceived as easier). | baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months |
Pediatric Evaluation of Disability (PEDI) | The PEDI assesses functional abilities and performance in children across three domains: self-care, mobility, and social function. It measures both capability and caregiver assistance.
Subscale range and full range uses scaled scores standardized to a 0-100 metric. Higher scores indicate better functional abilities and greater independence. | at 12 months |
Pediatric Quality of Life Inventory (PedsQL) | The PedsQL is a standardized patient-reported outcome measure assessing health-related quality of life in children across domains including physical, emotional, social, and school functioning.
Subscales range and full scale scores are transformed to a 0-100 scale. Higher scores indicate better health-related quality of life. | baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
12 Years
适龄性别
全部
- Age 12-17 years old
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening)
- Jebsen Taylor Hand Function Test Score of <37.08 on the affected side at time of screening visit (will be evaluated at screening)
- Ability to communicate and follow two step commands at the time of screening
- Ability to provide assent as detailed in consent form and based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent
Previous vagus nerve injury
Less than 12 years old or greater than 18 years old
History of left or bilateral vagotomy
Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc.
Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following:
- Acute suicidal thinking or behavior
- History of schizophrenia, schizoaffective disorder, or delusional disorders
- History of rapid cycling bipolar disorder
- Progressive neurological diseases
- Cardiac arrhythmias or other abnormalities
- History of dysautonomia including but not limited to orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope etc.
GMFCS score of less than II or greater than III (will be evaluated at screening)
Jebsen Taylor Hand Function Test Score of >37.08 on the affected side at time of screening visit (will be evaluated at screening)
Icahn School of Medicine at Mount Sinai研究责任方
David Putrino, 主要研究者, Professor, Icahn School of Medicine at Mount Sinai
研究中心联系人
联系人: Jenna Tosto Mancuso, PT, DPT,NCS, 212-241-8454, [email protected]
1 位于 1 个国家/地区的研究中心
New York
The Charles Lazarus Children's Abilities Center, New York, New York, 10029, United States
Jenna Tosto Mancuso, PT, DPT,NCS, 联系人, 212-241-8454, [email protected]
David Putrino, 主要研究者
招募中