The Movement of Botulinum Toxin Through the Lateral Gastrocnemius Muscle in Humans: An Expanded Examination
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Botulinum Toxin Muscle Effect (BTME) Volume of Abnormal Voxels Per MRI Slice in Muscles After Research Injections
研究概览
简要总结
Despite the wide-spread use of botulinum toxin (BT) to treat spasticity (increased muscle tone) in central neurological disease, evidence-based guidance on dosing, dilution, and injection technique is limited. The wide-spread use of BT in spasticity management, expense of these agents, and detrimental impact from movement into non-injected muscles mandates a better understanding of BT movement within muscles. A proof-of-concept paper written by investigators at Weill Cornell Medicine introduced a non-invasive MRI approach with "voxel thresholds" that was able to detect intramuscular effects of BT at 2 and 3 months post-injection of BT. The purpose of the current set of studies is to refine this MRI technique to better visualize the movement of botulinum toxin through muscle. In addition, the investigators plan to explore, using the imaging technique, how spastic muscle and differing dilutions affect BT movement in an effort to support the development of better research techniques to study toxin movement in human muscle.
详细描述
The research questions for the present study series are as followed:
- How does the movement and morphology of BT muscle effect (BTME) differ between standardized, research injections into spastic and non-spastic lateral gastrocnemius muscle (LGM)?
- How does the movement and morphology of BTME differ between a standardized, research injection into spastic LGM versus an injection using the same dose in a 100% greater dilution?
- Is there a predictable BTME within a given muscle following lower extremity BT clinical injections based on clinical need?
The two hypotheses are as followed:
First, it is predicted that BT muscle effect (BTME) will be greater in normal muscle than in spastic muscle.
Second, it is predicted that BTME will increase with increasing dilution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged 30-75
- •Diagnosis of any stroke (ischemic or hemorrhagic, first occurrence or recurrent)
- •Clinically significant lower extremity spasticity as assessed by PI that would benefit from BT treatment
- •Ambulatory with or without device and without assistance at household or greater level
- •Indication to inject gastrocnemius muscle (any combination of spastic lower extremity muscle injections are acceptable)
- •Goal of treatment may include improvement of gait, ankle range of motion, ankle foot orthosis fit, heel strike, ankle position in stance phase, decreased clonus, or relief from painful muscle spasms
- •Naïve to BT of any serotype in any lower extremity muscle
- •Naïve to phenol or alcohol treatment in any lower extremity muscle
排除标准
- •History of concomitant neurological disease (central or peripheral) other than stroke
- •Contraindication to intramuscular injection of BT
- •Medically unstable as determined by PI
- •Have an intrathecal baclofen pump
- •Contraindication for MRI (Subjects with MRI-compatible hip replacements may participate, but not those with total knee replacements due to artifact)
研究组 & 干预措施
Exp 2 & 3 - Arm 1
If within-subject design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM and one standard BT injection of of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic MGM.
If between-subjects design is adopted, subjects will receive one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic LGM.
干预措施: Botox (Drug)
Exp 2 & 3 - Arm 2
If within-subject study design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM and one experimental BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.50 cc of saline to their spastic MGM.
If between-subjects design is adopted, subjects will receive one standard BT injection of 25 units onobotulinumtoxinA (Botox®) diluted in 0.25 cc of saline to their spastic LGM.
干预措施: Botox (Drug)
结局指标
主要结局
Botulinum Toxin Muscle Effect (BTME) Volume of Abnormal Voxels Per MRI Slice in Muscles After Research Injections
时间窗: At MRI 2, 2 Months after Research Injection
BTME volume is calculated by counting the number of abnormal voxels (each voxel volume is .0015 cc) on MRI2, which have a relaxation time greater than or equal to 3 standard deviations above the baseline mean for a subject and their muscle found on their baseline MRI.
次要结局
- Change in Botulinum Toxin Muscle Effect (BTME) Volume of Abnormal Voxels Per MRI Slice in Muscles After Clinical Injections(At MRI 3, 2 Months after Clinical Injections)