Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 4
- 主要终点
- Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
研究概览
简要总结
The purpose of this study is to determine if electric stimulation to the leg, called transcutaneous tibial nerve stimulation (TTNS), can improve bladder outcomes in acute spinal cord injury.
详细描述
The purpose of this study is to see how well TTNS works at preventing incontinence in people with paraplegia from SCI that perform intermittent catheterization to empty their bladder. This study will compare the effectiveness of TTNS at 2 doses, fixed-dose and variable-dose. It will also evaluate the frequency of use, 2 days weekly compared to 5 days weekly.
Based on our pilot trials, tibial nerve stimulation protocols use submotor current intensity with a duration of 200 µs and a frequency of 20Hz. The experimental group will use a submotor "variable dose." The fixed-dose group will use submotor at current intensity at 1mA and designated as "fixed-dose."
TTNS will be used 5 days weekly, per our pilot trial. At 4-months post-SCI, the subject will be instructed to switch to 2x daily if he or she was randomized into the variable dose group of 2 days weekly and thus continue to doing so for the remainder of study participation. Because there is support in the literature for reduced doses of tibial nerve stimulation required for maintenance (1-3x weekly), the RCT includes this frequency comparison arm. All subjects will continue for 1-year post-SCI.
Additionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Subjects will be randomized to either Variable or fixed-dose (2:1) using a block size of 6 and stratified based on complete/incomplete SCI to ensure the equal allocation of the most severely injured in the two groups. The PI and investigators will be blinded to randomization and treatment allocation, managed by the research assistant.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years old
- •Traumatic or non-traumatic SCI
- •Admitted to inpatient rehabilitation within 6 weeks
- •T9 level of injury and above who are at greatest risk of morbid NGB
- •Regionally located to allow follow-up
- •English or Spanish speaking
排除标准
- •History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)
- •History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)
- •History of peripheral neuropathy
- •pre-SCI symptoms of peripheral neuropathy (numbness and/or tingling in feet, sharp/jabbing/burning pain in feet, sensitivity to touch, lack of coordination, muscle weakness, etc.)
- •Pregnancy
- •Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy
- •concern for tibial nerve pathway injury
- •absence of toe flexion or autonomic dysreflexia during electric stimulation test
- •Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis
研究组 & 干预措施
Variable-dose TTNS Protocol 5 x week
TTNS protocol: Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
All participants will be instructed to use the device for 30 minutes, 5 days per week for the first 4 months post-sci.
干预措施: Variable-dose TTNS Protocol 5 x week (Device)
Fixed-dose TTNS protocol
Fixed-dose protocol: Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes.
Both variable-dose TTNS and fixed-dose TTNS protocol participants will be instructed to use the device for 30 minutes, 5 days per week.
干预措施: Fixed-dose TTNS Protocol (Device)
Variable-dose TTNS Protocol 2 x week
At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.
干预措施: Variable-dose TTNS Protocol 2 x week (Device)
结局指标
主要结局
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
时间窗: 1 year post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
时间窗: 4 months post SCI
we expect bladder capacity to be maintained in those with effective TTNS
Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.
时间窗: Baseline, 4 months
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on change in urodynamic studies at baseline and 4-months
Change in bladder pathology from 4 month presence of detrusor overactivity and DSD as assessed by the urodynamics study at 1 year post SCI.
时间窗: 4 months and 1 year post SCI
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on the change in urodynamic studies at 4 months and 1-year
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
时间窗: Baseline
we expect bladder capacity to be maintained in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
时间窗: Baseline
Evidence of TTNS mechanism expected in those with effective TTNS
Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml
时间窗: 4 months post SCI
Evidence of TTNS mechanism expected in those with effective TTNS
Maintained bladder capacity as assessed by the Urodynamics study measured in ml
时间窗: 1 year post SCI
we expect bladder capacity to be maintained in those with effective TTNS
Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.
时间窗: Baseline, 4 months, 1 year post SCI
Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on change in urodynamic studies at baseline and 4-months
Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey
时间窗: At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.
Comparing I-QOL upon discharge from rehabilitation, 4-months post-injury and 1-year post-injury using incontinence QOL (I-QOL) survey, between and within both arms of the study
Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)
时间窗: Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.
Changes in Neurogenic Bladder Symptom Scores. The total score can range from 0 (no symptoms at all) to 74 (maximum symptoms) where a lower score indicates a better outcome.
Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes
时间窗: 2 days at the end of each month for 1 year.
Maintaining frequency of catheterization (count per day) and volumes per void (ml per collection)
次要结局
- Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey(At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.)
- Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)(Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.)
- Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes(2 days at the end of each month for 1 year.)
- Number of participants that show episodes of Autonomic Dysreflexia (AD) during bladder filling(Baseline)
- Number of participants that show episodes of AD during bladder filling(4 months)
- Number of participants that show episodes of AD during bladder filling(1 year post SCI)
- Change in systolic pressure during bladder filling(Baseline, 4 months, 1 year post SCI)
- Change in diastolic pressure during bladder filling(Baseline, 4 months, 1 year post SCI)
- Change in parasympathetic nervous system (PNS) activity differences during bladder filling as assessed by high frequency (HF) spectral component(Baseline, 4 months, 1 year post SCI)
- Change in sympathetic nervous system (SNS)activity differences during bladder filling as assessed by high frequency (HF) spectral component(Baseline, 4 months, 1 year post SCI)
研究者
Argyrios Stampas, MD
Spinal Cord Injury Medicine Research Director
The University of Texas Health Science Center, Houston