Spinal Cord Injuries
Conditions
Keywords
electric stimulation, SCI, spinal cord injury, neurogenic bladder
Brief summary
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.
Detailed description
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.
Interventions
DEVICEVariable-dose TTNS Protocol 5 x week
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.
DEVICEFixed-dose TTNS Protocol
Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury.
DEVICEVariable-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.
Sponsors
The University of Texas Health Science Center, Houston
MedStar National Rehabilitation Network
The Methodist Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
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.
Intervention model description
A prospective, double-blinded, randomized trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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 | 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) |
| Maintained bladder capacity as assessed by the Urodynamics study measured in ml | 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 | Baseline | Evidence of TTNS mechanism expected 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. | 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 | 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change in diastolic pressure during bladder filling | Baseline, 4 months, 1 year post SCI |
| Change in systolic pressure during bladder filling | Baseline, 4 months, 1 year post SCI |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORArgyrios Stampas, MD
UTHealth and TIRR Mermorial Hermann
PRINCIPAL_INVESTIGATORSuzanne Groah, MD
MedStar National Rehabilitation Hospital
Outcome results
None listed