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Neuromodulation Device

High Dose for Spinal Cord Injury (TTNS-RCT Trial)

N/A
Waitlist Available
Led By Argyos Stampas, 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months
Awards & highlights

Summary

This trial will test whether home transcutaneous tibial nerve stimulation (TTNS) can help improve quality of life for people with spinal cord injury (SCI).

Eligible Conditions
  • Spinal Cord Injury
  • Neurogenic Bladder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Neurogenic Bladder Symptoms (NGB) as Measured by the Neurogenic Bladder Symptom Score (NBSS)Scale.
Secondary outcome measures
Change in Quality of Life as Assessed by the I-QOL Questionnaire

Trial Design

2Treatment groups
Experimental Treatment
Group I: High DoseExperimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention
Low dose TTNS
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
High Dose
2008
Completed Phase 2
~360
Low dose
2016
Completed Phase 4
~480

Find a Location

Who is running the clinical trial?

National Center for Advancing Translational Sciences (NCATS)NIH
342 Previous Clinical Trials
410,418 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
934 Previous Clinical Trials
333,758 Total Patients Enrolled
Argyos Stampas, MDPrincipal InvestigatorUTHealth
~9 spots leftby Sep 2025
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