Recruiting

Injectrode TNS

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07264868

Conditions

Spinal Cord Injury (SCI)

Neurogenic Bladder (NB)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

iTNS

Sham iTNS

Study Details

Brief summary:

The purpose of this study is to determine the safety and efficacy of Injectrode Tibial Nerve Stimulation for bladder function in people with spinal cord injury.

Conditions

Spinal Cord Injury (SCI)

Neurogenic Bladder (NB)

Study ID

NCT07264868

Start date

May 7, 2026

Status verified date

May, 2026

Completion date

Sep 1, 2028

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Non-progressive chronic (>1 year) SCI
  • Neurologic level of injury T9 and above
  • Stable over active bladder (OAB) medications (≥3 months)
  • No contraindication to MRI (per MRI Safety Questionnaire)
  • English or Spanish speaking
  • Tolerate and be able to evoke toe flexion bilaterally with transcutaneous tibial nerve stimulation (tTNS) (self or assisted)
  • Pass the tTNS competency checklist to perform or direct performance of tTNS.

Exclusion Criteria:

  • Ongoing/active genitourinary oncologic diagnoses
  • History of other central nervous system disorder (CNS) disorders and/or peripheral neuropathy
  • Pregnancy or planning to become pregnant.
  • Lower Motor Neuron bladder
  • Restorative bladder surgery such as augmentation cystoplasty
  • Botulinum toxin-A injections in the bladder within 6 months of trial enrolment (injection in other sites is allowed)
  • Anticoagulation treatment or prophylaxis
  • Advanced peripheral vascular disease (gangrene, amputation, etc.)
  • History of intolerance to electrical stimulation, particularly of the leg

Study Design

Enrollment

21 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bilateral iTNS

participants will receive one active tibial nerve stimulation (TNS) device and both legs will receive active stimulation

active comparator: Unilateral iTNS

participants will receive one active and one sham tibial nerve stimulation (TNS) device. The treatment will only be delivered to the leg with the active device.

sham comparator: Sham iTNS

participants will receive one one sham tibial nerve stimulation (TNS) device for bilateral use.

Interventions

iTNS

The stimulation current will be gradually increased until bilateral toe flexion is achieved, then reduced to just below the motor contraction threshold. A 20 Hz frequency and 200 µs pulse width will be applied continuously for 30 minutes, five times a week.

Sham iTNS

The sham devices are designed to mimic active stimulation by initially delivering electrical current sufficient to evoke toe flexion. However, once the current is reduced to the sensory stimulation threshold, the device automatically ramps down to 0mA while maintaining the appearance of normal functioning on the display screen.

Primary outcome measure

  • Safety as assessed by the number of device-related adverse events [ Time Frame: From baseline to 8 weeks ]
  • Accuracy as assessed by the percentage of sessions where toe flexion was achieved as recorded in subject logs. [ Time Frame: From baseline to week 8 ]
  • Reliability as assessed by the average minimum current (mA) required to elicit toe flexion when testing for accuracy [ Time Frame: From baseline to week 8 ]
  • Feasibility of Injectrode procedure as assessed by surveys [ Time Frame: Week 8 ]
  • Physician acceptability of Injectrode device as assessed by a survey [ Time Frame: Week 8 ]
  • Participant acceptability of Injectrode device as assessed by a survey [ Time Frame: Week 8 ]
  • Feasibility and acceptability of the Injectrode treatment as assessed by a qualitative interview [ Time Frame: Week 8 ]

Central Contacts and Locations

Central contacts

Argyrios Stampas, MD

(713) 797-5938argyrios.stampas@uth.tmc.edu

Danira Garcia Gutierrez

(713) 797-7133Danira.GarciaGutierrez@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Argyrios Stampas, MD

713-797-5938argyrios.stampas@uth.tmc.edu

Danira Garcia Gutierrez

(713) 797-7133Danira.GarciaGutierrez@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-05-11.