Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-01-02 @ 1:01 PM
Study NCT ID:
NCT04350359
Status:
RECRUITING
Last Update Posted:
2025-07-14
First Post:
2020-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D001750', 'term': 'Urinary Bladder, Neurogenic'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D001745', 'term': 'Urinary Bladder Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'A prospective, double-blinded, randomized trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-11', 'studyFirstSubmitDate': '2020-04-02', 'studyFirstSubmitQcDate': '2020-04-14', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maintained bladder capacity as assessed by the Urodynamics study measured in ml', 'timeFrame': 'Baseline', 'description': 'we expect bladder capacity to be maintained in those with effective TTNS'}, {'measure': 'Maintained bladder capacity as assessed by the Urodynamics study measured in ml', 'timeFrame': '4 months post SCI', 'description': 'we expect bladder capacity to be maintained in those with effective TTNS'}, {'measure': 'Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml', 'timeFrame': 'Baseline', 'description': 'Evidence of TTNS mechanism expected in those with effective TTNS'}, {'measure': 'Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml', 'timeFrame': '4 months post SCI', 'description': 'Evidence of TTNS mechanism expected in those with effective TTNS'}, {'measure': 'Prolonged sensation with bladder filling as assessed by the Urodynamics study measured in ml', 'timeFrame': '1 year post SCI', 'description': 'Evidence of TTNS mechanism expected in those with effective TTNS'}, {'measure': 'Change in bladder pathology from baseline presence of detrusor overactivity and DSD as assessed by the urodynamics study at 4 months.', 'timeFrame': 'Baseline, 4 months', 'description': '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'}, {'measure': 'Change in bladder pathology from 4 month presence of detrusor overactivity and DSD as assessed by the urodynamics study at 1 year post SCI.', 'timeFrame': '4 months and 1 year post SCI', 'description': 'Reduced bladder pathology (presence of detrusor overactivity and DSD) in those with effective bladder neuromodulation based on the change in urodynamic studies at 4 months and 1-year'}], 'secondaryOutcomes': [{'measure': 'Evidence of improved quality of life in those with effective bladder neuromodulation based on Incontinence Quality of Life (I-QOL) survey', 'timeFrame': 'At discharge which could be up to 4 week from admission, 4-months post injury and at 1 year post injury.', 'description': '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'}, {'measure': 'Evidence of improved quality of life in those with effective bladder neuromodulation based on Neurogenic Bladder Symptom Score (NBSS)', 'timeFrame': 'Prior to discharge which could be up to 4 weeks from admission, monthly until 1 year post injury.', 'description': '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.'}, {'measure': 'Evidence of improved quality of life in those with effective bladder neuromodulation based on frequency of catheterization and voiding volumes', 'timeFrame': '2 days at the end of each month for 1 year.', 'description': 'Maintaining frequency of catheterization (count per day) and volumes per void (ml per collection)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['electric stimulation', 'SCI', 'spinal cord injury', 'neurogenic bladder'], 'conditions': ['Spinal Cord Injuries']}, 'referencesModule': {'references': [{'pmid': '15672627', 'type': 'BACKGROUND', 'citation': 'Ackery A, Tator C, Krassioukov A. A global perspective on spinal cord injury epidemiology. J Neurotrauma. 2004 Oct;21(10):1355-70. doi: 10.1089/neu.2004.21.1355.'}, {'pmid': '10736489', 'type': 'BACKGROUND', 'citation': 'Weld KJ, Dmochowski RR. Association of level of injury and bladder behavior in patients with post-traumatic spinal cord injury. Urology. 2000 Apr;55(4):490-4. doi: 10.1016/s0090-4295(99)00553-1.'}, {'pmid': '19403235', 'type': 'BACKGROUND', 'citation': 'Stohrer M, Blok B, Castro-Diaz D, Chartier-Kastler E, Del Popolo G, Kramer G, Pannek J, Radziszewski P, Wyndaele JJ. EAU guidelines on neurogenic lower urinary tract dysfunction. Eur Urol. 2009 Jul;56(1):81-8. doi: 10.1016/j.eururo.2009.04.028. Epub 2009 Apr 21.'}, {'pmid': '15672628', 'type': 'BACKGROUND', 'citation': 'Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.'}, {'pmid': '21488095', 'type': 'BACKGROUND', 'citation': 'Chaabane W, Guillotreau J, Castel-Lacanal E, Abu-Anz S, De Boissezon X, Malavaud B, Marque P, Sarramon JP, Rischmann P, Game X. Sacral neuromodulation for treating neurogenic bladder dysfunction: clinical and urodynamic study. Neurourol Urodyn. 2011 Apr;30(4):547-50. doi: 10.1002/nau.21009.'}, {'pmid': '25609546', 'type': 'BACKGROUND', 'citation': 'Chen G, Liao L, Li Y. The possible role of percutaneous tibial nerve stimulation using adhesive skin surface electrodes in patients with neurogenic detrusor overactivity secondary to spinal cord injury. Int Urol Nephrol. 2015 Mar;47(3):451-5. doi: 10.1007/s11255-015-0911-6. Epub 2015 Jan 22.'}, {'pmid': '22042300', 'type': 'BACKGROUND', 'citation': 'del Popolo G, Mencarini M, Nelli F, Lazzeri M. Controversy over the pharmacological treatments of storage symptoms in spinal cord injury patients: a literature overview. Spinal Cord. 2012 Jan;50(1):8-13. doi: 10.1038/sc.2011.110. Epub 2011 Nov 1.'}, {'pmid': '26352904', 'type': 'BACKGROUND', 'citation': 'Canbaz Kabay S, Kabay S, Mestan E, Cetiner M, Ayas S, Sevim M, Ozden H, Karaman HO. Long term sustained therapeutic effects of percutaneous posterior tibial nerve stimulation treatment of neurogenic overactive bladder in multiple sclerosis patients: 12-months results. Neurourol Urodyn. 2017 Jan;36(1):104-110. doi: 10.1002/nau.22868. Epub 2015 Sep 9.'}, {'pmid': '29196071', 'type': 'BACKGROUND', 'citation': 'Sirls ER, Killinger KA, Boura JA, Peters KM. Percutaneous Tibial Nerve Stimulation in the Office Setting: Real-world Experience of Over 100 Patients. Urology. 2018 Mar;113:34-39. doi: 10.1016/j.urology.2017.11.026. Epub 2017 Nov 28.'}, {'pmid': '26980078', 'type': 'BACKGROUND', 'citation': 'Fougere RJ, Currie KD, Nigro MK, Stothers L, Rapoport D, Krassioukov AV. Reduction in Bladder-Related Autonomic Dysreflexia after OnabotulinumtoxinA Treatment in Spinal Cord Injury. J Neurotrauma. 2016 Sep 15;33(18):1651-7. doi: 10.1089/neu.2015.4278. Epub 2016 Apr 13.'}, {'pmid': '20186953', 'type': 'BACKGROUND', 'citation': 'Sievert KD, Amend B, Gakis G, Toomey P, Badke A, Kaps HP, Stenzl A. Early sacral neuromodulation prevents urinary incontinence after complete spinal cord injury. Ann Neurol. 2010 Jan;67(1):74-84. doi: 10.1002/ana.21814.'}, {'pmid': '21305588', 'type': 'BACKGROUND', 'citation': 'de Seze M, Raibaut P, Gallien P, Even-Schneider A, Denys P, Bonniaud V, Game X, Amarenco G. Transcutaneous posterior tibial nerve stimulation for treatment of the overactive bladder syndrome in multiple sclerosis: results of a multicenter prospective study. Neurourol Urodyn. 2011 Mar;30(3):306-11. doi: 10.1002/nau.20958. Epub 2011 Feb 8.'}, {'pmid': '23098722', 'type': 'BACKGROUND', 'citation': 'McDonald JW 3rd, Sadowsky CL, Stampas A. The changing field of rehabilitation: optimizing spontaneous regeneration and functional recovery. Handb Clin Neurol. 2012;109:317-36. doi: 10.1016/B978-0-444-52137-8.00020-6.'}, {'pmid': '25520024', 'type': 'BACKGROUND', 'citation': 'Stampas A, Tansey KE. Spinal cord injury medicine and rehabilitation. Semin Neurol. 2014 Nov;34(5):524-33. doi: 10.1055/s-0034-1396006. Epub 2014 Dec 17.'}, {'pmid': '28526124', 'type': 'BACKGROUND', 'citation': "Stampas A, York HS, O'Dell MW. Is the Routine Use of a Functional Electrical Stimulation Cycle for Lower Limb Movement Standard of Care for Acute Spinal Cord Injury Rehabilitation? PM R. 2017 May;9(5):521-528. doi: 10.1016/j.pmrj.2017.03.005. No abstract available."}, {'pmid': '30284350', 'type': 'BACKGROUND', 'citation': 'Stampas A, Korupolu R, Zhu L, Smith CP, Gustafson K. Safety, Feasibility, and Efficacy of Transcutaneous Tibial Nerve Stimulation in Acute Spinal Cord Injury Neurogenic Bladder: A Randomized Control Pilot Trial. Neuromodulation. 2019 Aug;22(6):716-722. doi: 10.1111/ner.12855. Epub 2018 Oct 3.'}, {'pmid': '26904417', 'type': 'BACKGROUND', 'citation': 'Sanford MT, Suskind AM. Neuromodulation in neurogenic bladder. Transl Androl Urol. 2016 Feb;5(1):117-26. doi: 10.3978/j.issn.2223-4683.2015.12.01.'}, {'pmid': '30837835', 'type': 'BACKGROUND', 'citation': 'Stampas A, Gustafson K, Korupolu R, Smith C, Zhu L, Li S. Bladder Neuromodulation in Acute Spinal Cord Injury via Transcutaneous Tibial Nerve Stimulation: Cystometrogram and Autonomic Nervous System Evidence From a Randomized Control Pilot Trial. Front Neurosci. 2019 Feb 19;13:119. doi: 10.3389/fnins.2019.00119. eCollection 2019.'}, {'pmid': '15951736', 'type': 'BACKGROUND', 'citation': 'Finazzi Agro E, Campagna A, Sciobica F, Petta F, Germani S, Zuccala A, Miano R. Posterior tibial nerve stimulation: is the once-a-week protocol the best option? Minerva Urol Nefrol. 2005 Jun;57(2):119-23. English, Italian.'}, {'pmid': '26645117', 'type': 'BACKGROUND', 'citation': 'Manriquez V, Guzman R, Naser M, Aguilera A, Narvaez S, Castro A, Swift S, Digesu GA. Transcutaneous posterior tibial nerve stimulation versus extended release oxybutynin in overactive bladder patients. A prospective randomized trial. Eur J Obstet Gynecol Reprod Biol. 2016 Jan;196:6-10. doi: 10.1016/j.ejogrb.2015.09.020. Epub 2015 Oct 20.'}, {'pmid': '24274173', 'type': 'BACKGROUND', 'citation': 'Gaziev G, Topazio L, Iacovelli V, Asimakopoulos A, Di Santo A, De Nunzio C, Finazzi-Agro E. Percutaneous Tibial Nerve Stimulation (PTNS) efficacy in the treatment of lower urinary tract dysfunctions: a systematic review. BMC Urol. 2013 Nov 25;13:61. doi: 10.1186/1471-2490-13-61.'}, {'pmid': '16458733', 'type': 'BACKGROUND', 'citation': 'Dubeau CE. The aging lower urinary tract. J Urol. 2006 Mar;175(3 Pt 2):S11-5. doi: 10.1016/S0022-5347(05)00311-3.'}, {'pmid': '29184133', 'type': 'BACKGROUND', 'citation': 'Welk B, Lenherr S, Elliott S, Stoffel J, Presson AP, Zhang C, Myers JB. The Neurogenic Bladder Symptom Score (NBSS): a secondary assessment of its validity, reliability among people with a spinal cord injury. Spinal Cord. 2018 Mar;56(3):259-264. doi: 10.1038/s41393-017-0028-0. Epub 2017 Nov 29.'}, {'pmid': '17466735', 'type': 'BACKGROUND', 'citation': 'Schurch B, Denys P, Kozma CM, Reese PR, Slaton T, Barron R. Reliability and validity of the Incontinence Quality of Life questionnaire in patients with neurogenic urinary incontinence. Arch Phys Med Rehabil. 2007 May;88(5):646-52. doi: 10.1016/j.apmr.2007.02.009.'}, {'pmid': '22964752', 'type': 'BACKGROUND', 'citation': 'Bothig R, Fiebag K, Thietje R, Faschingbauer M, Hirschfeld S. Morbidity of urinary tract infection after urodynamic examination of hospitalized SCI patients: the impact of bladder management. Spinal Cord. 2013 Jan;51(1):70-3. doi: 10.1038/sc.2012.107. Epub 2012 Sep 11.'}, {'pmid': '17710104', 'type': 'BACKGROUND', 'citation': 'Pannek J, Nehiba M. Morbidity of urodynamic testing in patients with spinal cord injury: is antibiotic prophylaxis necessary? Spinal Cord. 2007 Dec;45(12):771-4. doi: 10.1038/sj.sc.3102114. Epub 2007 Aug 21.'}, {'pmid': '23981816', 'type': 'BACKGROUND', 'citation': 'Street JT, Noonan VK, Cheung A, Fisher CG, Dvorak MF. Incidence of acute care adverse events and long-term health-related quality of life in patients with TSCI. Spine J. 2015 May 1;15(5):923-32. doi: 10.1016/j.spinee.2013.06.051. Epub 2013 Aug 24.'}, {'pmid': '9431366', 'type': 'BACKGROUND', 'citation': 'Montgomerie JZ. Infections in patients with spinal cord injuries. Clin Infect Dis. 1997 Dec;25(6):1285-90; quiz 1291-2. doi: 10.1086/516144. No abstract available.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nBased 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."\n\nTTNS 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.\n\nAdditionally, we are collecting surveys to help identify characteristics of people (resilience and confidence) and adherence to medication and TTNS use throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18-75 years old\n* Traumatic or non-traumatic SCI\n* Admitted to inpatient rehabilitation within 6 weeks\n* T9 level of injury and above who are at greatest risk of morbid NGB\n* Regionally located to allow follow-up\n* English or Spanish speaking\n\nExclusion Criteria:\n\n* History of genitourinary diagnoses (i.e. prostate hypertrophy, overactive bladder, cancer, etc.)\n* History of central nervous system disorder (i.e. prior SCI, stroke, brain injury, Parkinson's disease, MS, etc.)\n* History of peripheral neuropathy\n* 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.)\n* Pregnancy\n* Known injury to the lumbosacral spinal cord or plexus, or pelvis with associated neuropathy\n* concern for tibial nerve pathway injury\n* absence of toe flexion or autonomic dysreflexia during electric stimulation test\n* Potential for progressive SCI including neurodegenerative SCI, ALS, cancer myelopathy, Multiple sclerosis, transverse myelitis"}, 'identificationModule': {'nctId': 'NCT04350359', 'acronym': 'TTNS1yr', 'briefTitle': 'Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Transcutaneous Tibial Nerve Stimulation for Spinal Cord Injury Neurogenic Bladder', 'orgStudyIdInfo': {'id': 'HSC-MS-19-0756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Variable-dose TTNS Protocol 5 x week', 'description': '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.\n\nAll participants will be instructed to use the device for 30 minutes, 5 days per week for the first 4 months post-sci.', 'interventionNames': ['Device: Variable-dose TTNS Protocol 5 x week']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fixed-dose TTNS protocol', 'description': '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.\n\nBoth variable-dose TTNS and fixed-dose TTNS protocol participants will be instructed to use the device for 30 minutes, 5 days per week.', 'interventionNames': ['Device: Fixed-dose TTNS Protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Variable-dose TTNS Protocol 2 x week', 'description': '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.', 'interventionNames': ['Device: Variable-dose TTNS Protocol 2 x week']}], 'interventions': [{'name': 'Variable-dose TTNS Protocol 5 x week', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Variable-dose TTNS Protocol 5 x week']}, {'name': 'Fixed-dose TTNS Protocol', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Fixed-dose TTNS protocol']}, {'name': 'Variable-dose TTNS Protocol 2 x week', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Variable-dose TTNS Protocol 2 x week']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Emily Leonard, PhD', 'role': 'CONTACT', 'email': 'Emily.M.Leonard@Medstar.net', 'phone': '202-877-1844'}, {'name': 'Inger Ljungberg, MPH', 'role': 'CONTACT', 'email': 'Inger.H.Ljungberg@medstar.net', 'phone': '202-877-1694'}, {'name': 'Suzzane Groah, MD., MSPH', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar National Rehabilitation Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Vanessa Bernal, CCRP', 'role': 'CONTACT', 'email': 'Vanessa.Bernal@uth.tmc.edu', 'phone': '713-797-7636'}, {'name': 'Eduardo Bauer, MD', 'role': 'CONTACT', 'email': 'Eduado.G.Bauer@uth.tmc.edu', 'phone': '713-797-7162'}, {'name': 'Argyrios Stampas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'TIRR Memorial Hermann Research Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Argyrios Stampas, MD', 'role': 'CONTACT', 'email': 'argyrios.stampas@uth.tmc.edu', 'phone': '713-797-5938'}], 'overallOfficials': [{'name': 'Argyrios Stampas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTHealth and TIRR Mermorial Hermann'}, {'name': 'Suzanne Groah, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MedStar National Rehabilitation Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'MedStar National Rehabilitation Network', 'class': 'OTHER'}, {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Spinal Cord Injury Medicine Research Director', 'investigatorFullName': 'Argyrios Stampas, MD', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}