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Behavioural Intervention

TTNS for Neurogenic Bladder (TTNS1yr Trial)

N/A

Recruiting

Led By Suzanne Groah, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

T9 level of injury and above who are at greatest risk of morbid NGB

Diagnosed with traumatic or non-traumatic SCI

Must not have

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.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post sci

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if TTNS can help improve bladder function in people with acute spinal cord injury.

Who is the study for?

This trial is for adults aged 18-75 with a spinal cord injury at T9 level or above, who are within 6 weeks of inpatient rehabilitation and can follow up regionally. Participants must speak English or Spanish. Excluded are those with tibial nerve damage, toe flexion issues during tests, pregnancy, pre-injury neuropathy symptoms, progressive SCI conditions like ALS or MS, genitourinary disorders history, CNS disorders history.

What is being tested?

The study examines if transcutaneous tibial nerve stimulation (TTNS), an electric leg stimulation therapy given either five times a week or twice a week at variable doses or as a fixed dose protocol can improve bladder control in patients with recent acute spinal cord injuries.

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the leg and possible skin irritation due to repeated use of the TTNS device. There might also be unintended muscle twitches during stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal injury is above the T9 level and I'm at high risk of severe bladder problems.

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I have a spinal cord injury.

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I am between 18 and 75 years old.

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I have a spinal cord injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had nerve damage in my hands or feet.

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I had symptoms like numbness or pain in my feet before my spinal cord injury.

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I have nerve damage due to an injury in my lower back or pelvis.

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I have a history of a central nervous system disorder.

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My condition may worsen and includes ALS, MS, or spinal cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post sci

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post sci

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post sci for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in bladder pathology from 4 month presence of detrusor overactivity and DSD as assessed by the urodynamics study at 1 year post SCI.

Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.

Maintained bladder capacity as assessed by the Urodynamics study measured in ml

+1 more

Secondary study objectives

Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey

Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)

Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Variable-dose TTNS Protocol 5 x weekActive Control1 Intervention

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.

Group II: Fixed-dose TTNS protocolActive Control1 Intervention

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.

Group III: Variable-dose TTNS Protocol 2 x weekActive Control1 Intervention

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.

0 / 9Eligibility criteria met