Neuromodulation of Spinal Circuits: Effects on Spasticity, Nociception, and Motor Activation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Pendulum Test
研究概览
简要总结
Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that may be valuable for reducing spasticity without the side effects of antispasticity medications. The intensity of stimulation, or dose, that promotes the best response is not known. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.
详细描述
Spasticity involves involuntary muscle activity in persons with spinal cord injury (SCI) that can include increased response to muscle stretch and physical touch, as well as muscle stiffness. Due to the combination of symptoms, several drug therapies are currently prescribed to reduce spasticity but they may have negative side effects including fatigue and muscle weakness. Transcutaneous spinal stimulation (TSS) is a form of electrical stimulation delivered over the skin of the spine that seems to have effects that are similar to drug therapy. Prior studies of TSS in persons with SCI suggest that TSS can reduce spasticity without negative side effects. The intensity of stimulation, or dose, that promotes the best response is not known. In addition, sensitive measurements are necessary to assess the changes that can be seen in multiple presentations of spasticity. Understanding the response to different intensities of stimulation and how they affect spasticity will help guide rehabilitation for persons with SCI. Therefore, this study aims to identify the effects of TSS as a non-drug intervention for spasticity management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must meet all of the following criteria to be eligible for the study:
- •Ability and willingness to authorize the use of protected health information (PHI)
- •Be 16 years of age or older
- •Have a SCI with any severity classification (AIS A, B, C, or D) that occurred at least 3 months ago
- •Have at least mild "spasticity" affecting lower extremity muscles, as indicated by a pendulum test first swing excursion angle of ≤ 77° or ≥ 5 beats of clonus on the ankle drop test
- •Use of prescription medications is acceptable, as long as the dosage has not changed in the last 2 weeks and notification of medication changes is made during study participation
- •Ability to follow multiple commands
- •Ability to communicate pain or discomfort
排除标准
- •The presence of any one of the following criteria leads to exclusion:
- •Progressive or potentially progressive spinal lesions, including degenerative, or progressive vascular disorders of the spine and/or spinal cord
- •Neurologic level below spinal level T12
- •History of cardiovascular irregularities (e.g. atrial fibrillation)
- •Active cancer or a history of cancer
- •Orthopedic pathology that would limit participation in the protocol (e.g. knee or hip flexion contractures of greater than 10 degrees)
- •Use of semi-permanent or permanent anti-spasmodic treatment (i.e. botox, selective dorsal rhizotomy)
- •Women who are pregnant, or who have reason to believe they are, or may become pregnant due to unknown risks to the fetus associated with TSS
- •Persons who have implanted stimulators of any type will be excluded due to unknown potential of electrical stimulation effects (e.g. baclofen pump, epidural spinal stimulator, implanted cardiac defibrillator, diaphragmatic pacemaker)
- •Active infection of any type, as infection may exacerbate spasticity resulting in inability to identify the influence of the treatment
- •Skin irregularities, sensitivity, or lesions that would increase the risk of stimulation-associated adverse events
结局指标
主要结局
Change in Pendulum Test
时间窗: Before and Immediately after each intervention session through study completion, an average of 2 weeks
The pendulum test will be performed during which the participant will be positioned supine on a mat with the lower leg hanging over the mat. A member of the study staff will support the participant's extended lower leg and then release the leg allowing it to swing freely. Muscle activity during each maneuver will be recorded using electromyography (EMG) of the quadriceps, hamstrings, tibialis anterior, and soleus muscles of the lower extremity identified as having the greatest spasticity. Biomechanical measurements will be captured through the use of an electrogoniometer placed at the knee joint.
次要结局
- Change in Plantar Flexor Reflex Response(Before and Immediately after each intervention session through study completion, an average of 2 weeks)
- Change in Ankle Clonus Test(Before and Immediately after each intervention session through study completion, an average of 2 weeks)
- Qualities of Spasticity Survey(Before and Immediately after each intervention session through study completion, an average of 2 weeks)
- Modified Penn Spasm Frequency Scale(Before and four hours after each intervention session through study completion, an average of 2 weeks)
- Change in posterior root muscle reflexes (PRMRs)(Before and Immediately after each intervention session through study completion, an average of 2 weeks)
- Stimulation Tolerability Questionnaire(Immediately following each intervention session through study completion, an average of 2 weeks.)
研究者
Edelle Field-Fote, PT, PhD
Director, Spinal Injury Research & The Hulse Spinal Injury Laboratory
Shepherd Center, Atlanta GA