Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT04350359
Status
Recruiting
Apply to this trial

Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Variable-dose TTNS Protocol 5 x week — DEVICE
    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.
  • Fixed-dose TTNS Protocol — DEVICE
    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.
  • Variable-dose TTNS Protocol 2 x week — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jun 8, 2020
Status verified
Apr 2026
Primary completion
Jul 1, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Maintained bladder capacity as assessed by the Urodynamics study measured in ml [ Time Frame: Baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MedStar National Rehabilitation HospitalWashington D.C.District of Columbia20010
Emily Leonard, PhD
[email protected]
202-877-1844
Inger Ljungberg, MPH
[email protected]
202-877-1694
Suzzane Groah, MD., MSPH (PRINCIPAL_INVESTIGATOR)
TIRR Memorial Hermann Research CenterHoustonTexas77030
Vanessa Bernal, CCRP
[email protected]
713-797-7636
Eduardo Bauer, MD
[email protected]
713-797-7162
Argyrios Stampas, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Washington D.C., DC

By research site
MedStar National Rehabilitation Hospital· Washington D.C., DCTIRR Memorial Hermann Research Center· Houston, TX

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