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tSCS and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy II期 80 随机化
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临床试验NCT07433023旨在研究其他，主要针对脑瘫。这是一项II期 干预性研究试验，当前状态为尚未招募。试验尚未开始，计划于2026年3月1日开始，预计招募80名患者。该研究由Shirley Ryan AbilityLab主导，计划于2029年1月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年2月25日。
简要概括
This is an intervention study to investigate the impact of spinal stimulation on mobility outcomes in children with Cerebral Palsy. Participants will complete a 16-week training program with weekly sessions of spinal stimulation and walking or activity-based training. Participants will also have the option to participate in a randomized control trial to investigate the impact of 5-Azacitidine combined with the spinal...显示更多
详细描述
This project will investigate the impact of transcutaneous spinal cord stimulation (tSCS) on gait and activity-based training in children with Cerebral Palsy. Through a 1:1 randomization, a subset of participants will also receive a dose of 5-azacitidine (AZA), an FDA-approved drug for pediatric oncology, or a placebo. Research in muscle fibers as shown that AZA aids in muscle growth and regeneration. The use of AZA ...显示更多
官方标题
Advancing Neurorehabilitation: Evaluating Transcutaneous Spinal Stimulation and 5-Azacitidine for Enhanced Motor Outcomes in Cerebral Palsy
疾病
脑瘫其他研究标识符
- STU00225218
NCT编号
实际开始日期
2026-03-01
最近更新发布
2026-02-25
预计完成日期
2029-01-01
计划入组人数
80
研究类型
干预性研究
试验分期 (阶段)
II期
试验状态
尚未招募
关键词
Pediatric
Transcutaneous Spinal Stimulation
Transcutaneous Spinal Stimulation
主要目的
其他
分配方式
随机
干预模型
平行
盲法
三盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
阳性对照tSCS + Functional Activity Training Transcutaneous spinal cord stimulation will be paired with training based on Aim.
Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.
Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate. | tSCS Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment. Functional Activity Training All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training.
Participants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training. |
实验性tSCS + Functional Activity Training + 5-Azacitidine Transcutaneous spinal cord stimulation will be paired with training based on Aim.
Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.
Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate.
A subset of opt-in participants will also be ra...显示更多 | tSCS Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment. 5-Azacitidine A subset of opt-in participants will receive a single subcutaneous injection of 5-Azacitidine at a dose of 75 mg/m² Functional Activity Training All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training.
Participants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training. |
阳性对照tSCS + Functional Activity Training + Mannitol (Placebo) Transcutaneous spinal cord stimulation will be paired with training based on Aim.
Participants in Aim 1(GMFCS levels 1-3) will engage in three sessions a week for 16 weeks of treadmill and overground gait training using tSCS.
Participants in Aim 2(GMFCS levels 4-5) will engage in three sessions a week for 16 weeks of functional activity based training as appropriate.
A subset of opt-in participants will also be ra...显示更多 | tSCS Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation and activity based training. Stimulation intensity will be based on involuntary motor threshold, determined during a MEPs assessment. 甘露醇 A subset of opt-in participants will receive a single subcutaneous injection of Mannitol (placebo) at a dose of 75 mg/m². Functional Activity Training All participants will engage in functional activity training based on Aim. Participants will participate in three 45 minute sessions per week for a total of 16 weeks involving transcutaneous spinal stimulation (tSCS) and activity based training.
Participants in Aim 1 will complete gait training. Participants in Aim 2 will complete activity-based training. |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Spatiotemporal Gait Symmetry via Instrumented Gait-Mat | For Aim 1 participants (GMFCS levels 1-3), an instrumented gait-mat will be used to assess spatiotemporal gait symmetry. | Baseline to Follow-Up, approximately 22 weeks |
Modified Tardieu Scale | For Aim 2 participants (GMFCS levels 4-5), muscle spasticity will be assessed using the Modified Tardieu Scale. | Baseline to Follow-Up, approximately 22 weeks |
参与助手
资格标准
适龄参与研究
儿童
最低年龄要求
4 Years
适龄性别
全部
- Diagnosis of cerebral palsy (CP) classified as Gross Motor Function Classification System (GMFCS) Levels I-V.
- Between 4 and 17 years old at the time of enrollment/consent.
- Diagnosis of spastic CP hemiplegia, diplegia, or quadriplegia.
- Stable medical condition as determined by the investigator.
- Adequate caregiver support to be able to participate in training and assessment sessions for the duration of the study, at the discretion of the Investigator.
- Capable of performing simple cued motor tasks and can follow 2-3 step commands.
- Capable of communicating an accurate yes or no answer to questions according to parent or guardian.
- Able to localize pain/ discomfort.
- Physician approval for participation.
- Parent/ guardian permission.
- Concurrent neurological disease affecting the central nervous system.
- Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
- Orthopedic dysfunction, injury, or surgery that would impact an individual's ability to use the upper and/or lower extremity
- Unhealed fracture or other musculoskeletal impairment that might interfere with upper or lower extremity rehabilitation or testing activities
- Implanted stimulator (e.g., epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant) or drug delivery device (e.g., baclofen pump)
- Dependence on an electro-magnetic medical implant (e.g., cardiac pacemaker, implanted drug pump), ventilation support, or another external device.
- History of uncontrolled seizures
- Unexplained presence of persistent complaints of pain of any kind
- Unable to localize pain/discomfort
- Severe cortico-visual impairment
- Active pressure sores
- Active urinary tract infection
- Active cancer or cancer in remission less than 5 years
- Clinically significant depression, psychiatric disorders, or ongoing drug abuse
- Immunodeficiency or hematologic condition
- Allergy to AZA or mannitol
- Plans to receive a vaccine within 30 days of the planned AZA or placebo injection to take place at week 10
- Pregnancy
- Orthopedic surgery completed in the prior 12 months
- Intrathecal medication titration that may affect muscle spasticity
- Botulinum toxin treatment within 3 months preceding enrollment unless given approval by the treating physician
- Current enrollment in a conflicting research study
- Any other health condition or diagnosis not listed above that may put the participant at risk as determined by the investigator or treating physician
Shirley Ryan AbilityLab研究责任方
Arun Jayaraman, PT, PhD, 主要研究者, Scientific Chair, Technology & Innovation, Shirley Ryan AbilityLab
研究中心联系人
联系人: Audrey Wiesner, BS, 3122388435, [email protected]
联系人: Jacklyn Stoller, PT, DPT, 3122387620, [email protected]
1 位于 1 个国家/地区的研究中心
Illinois
Shirley Ryan AbilityLab, Chicago, Illinois, 60611, United States
Arun Jayaraman, PhD, 主要研究者