NCT03439319已完成不适用
Restoration of Reaching and Grasping Function in Individuals With Spinal Cord Injury Using MyndMove® Neuromodulation Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MyndTec Inc.
- 入组人数
- 51
- 试验地点
- 7
- 主要终点
- To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC)
研究概览
简要总结
A two-arm, parallel group, multicentre, single-blind, randomized controlled trial comparing electrical neuromodulation delivered by MyndMove® therapy to intensive upper-limb conventional therapy in the treatment of patients with moderate to severe motor impairment to their arms and hands from an incomplete, traumatic spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic incomplete (AIS B-D) C4-C7 spinal cord injury
- •Paralysis or paresis in both upper extremities
- •At least 4 months (120 days) and less than 96 months (2,920 days) post traumatic SCI
- •Baseline SCIM-SC ≤ 10
- •From an inpatient or outpatient care setting
- •Able to understand and follow instructions
- •Able to tolerate being in a seated position for a least one hour required to deliver upper limb therapy
- •Willing to attend treatment sessions and all assessment sessions
- •Able to understand and provide informed consent
- •Male and female participants ≥ 18 years of age at the time of enrollment
排除标准
- •Previous history of any other neuromuscular disorder or conditions that may affect motor response
- •Upper extremity injury or condition prior to SCI that limits the function of the hand or arm
- •Malignant skin lesion on the affected upper extremity
- •Rash or open wound at any potential electrode site
- •History of seizure disorder not effectively managed by seizure medications
- •An implanted metallic part (e.g. plates, screws or joint replacement) or electrical device (e.g. Implantable Cardiac Defibrillator, Pacemaker, Spinal Stimulation). (Note: If the participant has passive metallic implants, the therapy can be delivered if the implants are located in an area other than where the electrical stimulant is to be delivered.)
- •Complete denervation of muscles that are targeted by MyndMove such that MyndMove is unable to elicit tetanic muscle contraction when upper limits of stimulation intensity for the targeted muscle are applied
- •Poorly controlled autonomic dysreflexia (as determined by the local site physician)
- •History of psychiatric illness requiring hospitalization within the past 24 months
- •Active drug treatment for dementia
- •Life expectancy of less than 12 months due to other illness
- •In the judgment of the medical provider, the participant has medical complications that may interfere with the execution of the study
- •Currently enrolled in another upper limb study and/ or has received MyndMove Therapy within the past 3 months
- •Enrolled, in the past six months, in a clinical study involving drugs or biologics
- •Currently dependent on a ventilator
- •Botulinum toxin injection into affected upper extremity and the muscle targeted by MyndMove® therapy within 6 months prior to the study start. No botulinum toxin injections in the upper extremity during the study treatment and follow up period
- •Females who are pregnant or planning to become pregnant in the duration of the trial
- •Regional disorder of the upper extremities such as fracture, dislocation, or joint contractures to less than 50% of the expected range of motion
结局指标
主要结局
To compare the efficacy of MyndMove® therapy vs intensive conventional therapy in improving upper extremity function as measured by Spinal Cord Independence Measure self-care sub score (SCIM-SC)
时间窗: Change from baseline to 6weeks to 14 weeks to 24weeks
SCIM-SC is a disability scale that has been specifically developed to evaluate the functional outcomes of patients with traumatic and non-traumatic SCI. The SCIM-SC assesses function of self-care, which includes feeding, bathing, dressing and grooming.
次要结局
- Change in participant's reaching and grasping function with the Toronto Rehab Institute Hand Function Test (TRI-HFT)(Change from baseline to 14 weeks to 24weeks)
- Change in quality of life as measured by the Spinal Cord Injury-Quality of Life (SCI-QOL)(Change from baseline to 6weeks to 14weeks to 24weeks)
- Change in participant's upper limb and hand impairment and function using Graded Refined Assessment of Strength Sensibility and Prehension (GRASSP)(Change from baseline to 6weeks to 14weeks to 24weeks)
- To assess safety as measured by serious and non serious adverse events (SAEs) recorded for participants in both groups of the study population over the duration of the study(Duration of the trial from baseline to 24weeks)
研究者
研究点 (7)
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