| 1 |
NCT03696927 |
Completed |
Active Powered Prosthesis (APEX) for Spinal Cord Injury |
|
- Device: Active Powered Prosthesis (APEX) for Spinal Cord Injury
|
Interventional
|
Not Applicable |
- AbiliTech Medical Inc.
- Courage Kenny Rehabilitation Institute
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
|
Industry / Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Device Feasibility
|
- User ability to operate the APEX device
|
4 |
All |
18 Years and older (Adult, Older Adult) |
NCT03696927 |
6100003-100 Rev A
R43HD094440 |
|
August 29, 2018 |
August 29, 2018 |
August 29, 2018 |
October 5, 2018 |
October 5, 2018 |
|
- Allina Health Courage Kenny Rehabilitation Institute
Minneapolis, Minnesota, United States
|
|
| 2 |
NCT02592668 |
Active, not recruiting |
Spinal Cord Injury Epidural Stimulation |
|
- Device: Epidural Stimulator
|
Interventional
|
Not Applicable |
- Mayo Clinic
- University of California, Los Angeles
- Reneu Health Inc.
- (and 3 more...)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Duration of time for which subject can sit unassisted on the edge of a mat table
- Assessment of volitional movement of lower limbs
- Subject's ability to coordinate stepping on a treadmill will be measured using biomechanical and electrophysiological analyses
- (and 13 more...)
|
2 |
All |
21 Years to 65 Years (Adult, Older Adult) |
NCT02592668 |
15-000510
UL1TR000135 |
|
February 2016 |
April 2019 |
April 2019 |
October 30, 2015 |
December 11, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 3 |
NCT03308565 |
Recruiting |
Adipose Stem Cells for Traumatic Spinal Cord Injury |
- Spinal Cord Injuries
- Paralysis
|
- Biological: Autologous, Adipose derived Mesenchymal Stem Cells
|
Interventional
|
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of acute adverse events
- Incidence of delayed adverse events
- Severity of adverse events
- (and 19 more...)
|
10 |
All |
18 Years and older (Adult, Older Adult) |
NCT03308565 |
17-004621 |
CELLTOP |
December 5, 2017 |
November 2022 |
November 2023 |
October 12, 2017 |
January 16, 2018 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
|
| 4 |
NCT03026816 |
Recruiting |
Epidural Stimulation After Neurologic Damage |
- Spinal Cord Injuries
- Paraplegia, Complete
|
- Device: Epidural Spinal Cord Stimulation
|
Interventional
|
Not Applicable |
- University of Minnesota - Clinical and Translational Science Institute
- Minnesota Office of Higher Education
- Minneapolis Veterans Affairs Medical Center
- (and 2 more...)
|
Other / U.S. Fed |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Volitional Response Index Magnitude
- Change in Blood pressure (Systolic and Diastolic)
- Cerebrovascular Assessment Change
- (and 3 more...)
|
100 |
All |
22 Years and older (Adult, Older Adult) |
NCT03026816 |
16-4115 |
E-STAND |
August 7, 2017 |
January 2022 |
January 2023 |
January 20, 2017 |
February 19, 2018 |
|
- Hennepin County Medical Center
Minneapolis, Minnesota, United States
|
|
| 5 |
NCT02700178 |
Recruiting |
Biofeedback for Wheelchair Users |
|
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- change in risk of shoulder impingement
- change in wrist posture
|
15 |
All |
18 Years to 60 Years (Adult) |
NCT02700178 |
15-008240 |
|
April 2016 |
September 2018 |
September 2018 |
March 7, 2016 |
January 23, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 6 |
NCT03261388 |
Recruiting |
Activity Based Locomotor Exercise PrOgram—Wait-list controllEd Research |
|
- Behavioral: Activity-Based Locomotor Exercise Program (ABLE)
|
Observational
|
|
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Change in Neuromuscular Recovery Scale (NRS)
- Change in Canadian Occupational Performance Measure (COPM)
- Change in Craig Handicap Assessment and Reporting Technique (CHART)
- Change in American Spinal Injury Association Impairment Scale (AIS)
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT03261388 |
CK-1604 |
ABLE-POWER |
November 7, 2016 |
January 31, 2022 |
January 31, 2022 |
August 25, 2017 |
August 28, 2018 |
|
- Courage Kenny Rehabilitation Institute
Golden Valley, Minnesota, United States
|
|
| 7 |
NCT02777281 |
Suspended |
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI |
- Shoulder Pain
- Spinal Cord Injury
|
- Behavioral: Shoulder pain and SCI
- Behavioral: Shoulder pain and able bodies
|
Interventional
|
Not Applicable |
- University of Minnesota - Clinical and Translational Science Institute
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Muscle activity
- Rotator cuff compression risk
|
60 |
All |
21 Years to 60 Years (Adult) |
NCT02777281 |
SCIR01HD080857-01 |
|
September 2015 |
December 2019 |
December 2019 |
May 19, 2016 |
February 26, 2018 |
|
- University of Minnesota
Minneapolis, Minnesota, United States
|
|
| 8 |
NCT03392155 |
Active, not recruiting |
Performance and Nutrition Program for Athletes in Adaptive Sports |
- Spinal Cord Injuries
- Physical Disability
|
- Behavioral: Training & Nutrition
|
Interventional
|
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Change in The World Health Organization Quality of Life Score (WHOQOL-BREF)
- Change in exercise self-efficacy score (for participants not living with spinal cord injury)
- Change in exercise self-efficacy score (for participants living with spinal cord injury)
- Change in self-reported un-weighed food records
|
15 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03392155 |
17-005392 |
|
January 9, 2018 |
October 31, 2018 |
December 31, 2018 |
January 5, 2018 |
August 15, 2018 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 9 |
NCT02616081 |
Active, not recruiting |
Patient Reported Outcomes for Bladder Management Strategies in Spinal Cord Injury |
- Neurogenic Bladder
- Spinal Cord Injuries
- Quality of Life
- Incontinence
|
- Other: Clean Intermittent Catheterization
- Other: Indwelling Catheter
- Other: Bladder Surgery
|
Observational
|
|
- University of Utah
- Patient-Centered Outcomes Research Institute
- University of Minnesota - Clinical and Translational Science Institute
- University of Michigan
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Patient reported QoL using the SCI-QoL and subdomains of SCI-QoL (physical, mental and social function) for three bladder management strategies: CIC, IDC, and bladder surgery.
- Patient reported urinary specific bothers and complications with their Neurogenic Bladder Symptom Score for three bladder management strategies: CIC, IDC, and bladder surgery.
- Complication rates and overall QoL (using the SCI-QoL) for three bladder management strategies: CIC, IDC, and bladder surgery.
|
1500 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT02616081 |
82971 |
NBRG-PCORI |
January 2016 |
July 2018 |
December 2018 |
November 26, 2015 |
August 22, 2018 |
|
- University of Michigan
Ann Arbor, Michigan, United States - University of Minnesota
Minneapolis, Minnesota, United States - University of Utah
Salt Lake City, Utah, United States
|
|
| 10 |
NCT03082898 |
Recruiting |
Mobility and Therapeutic Benefits Resulting From Exoskeleton Use in a Clinical Setting (SC140121 Study 1) |
|
- Device: Indego Exoskeleton
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Ten meter walk test
- Six minute walk test
- WICSI-II
- (and 11 more...)
|
24 |
All |
18 Years and older (Adult, Older Adult) |
NCT03082898 |
SC140121 |
|
November 2016 |
November 2019 |
June 2020 |
March 17, 2017 |
January 29, 2018 |
|
- Tampa VA
Tampa, Florida, United States - Mayo Clinic
Rochester, Minnesota, United States - Vanderbilt
Nashville, Tennessee, United States
|
|
| 11 |
NCT03083366 |
Recruiting |
Sacral Nerve Stimulation in Improving Bladder After Acute Traumatic Spinal Cord Injury |
- Spinal Cord Injury, Acute
- Neurogenic Bladder
- Incontinence
- Urinary Tract Infections
|
- Device: PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
|
Interventional
|
Not Applicable |
- University of Utah
- University of Minnesota - Clinical and Translational Science Institute
- University of Michigan
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Urodynamic determined maximum cystometric capacity
- Quality of Life differences measured by mean SCI-QoL
- Number of urinary tract infections per year
- (and 17 more...)
|
60 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT03083366 |
96153 |
|
September 1, 2016 |
March 2019 |
October 2019 |
March 20, 2017 |
August 23, 2018 |
|
- University of Michigan
Ann Arbor, Michigan, United States - University of Minnesota
Minneapolis, Minnesota, United States - University of Utah
Salt Lake City, Utah, United States
|
|
| 12 |
NCT02600910 |
Recruiting |
Natural History of Shoulder Pathology in Manual Wheelchair Users |
- Paraplegia
- Spinal Cord Injuries
- Shoulder Pain
- Tendinopathy
|
|
Observational
|
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Participant completion of MRI and Field measurements after 3 to 5 years follow-up.
- Development of the Conceptual Model of Preclinical Natural History of Shoulder Health Decline.
|
75 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02600910 |
15-004974 |
NHSSI |
November 2015 |
December 2019 |
December 2020 |
November 9, 2015 |
February 23, 2017 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
|
| 13 |
NCT01597518 |
Recruiting |
Riluzole in Spinal Cord Injury Study |
|
- Drug: Riluzole
- Drug: Placebo
|
Interventional
|
Phase 2
Phase 3 |
- AOSpine North America Research Network
- AOSpine International
- Christopher Reeve Paralysis Foundation
- (and 2 more...)
|
Other / Industry / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in ISNCSCI Total Motor Score between 180 days and baseline
|
351 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01597518 |
SPN-12-001 |
RISCIS |
October 2013 |
December 2024 |
May 2025 |
May 14, 2012 |
November 2, 2018 |
|
- Barrow Neurological Institute
Phoenix, Arizona, United States - University of Miami
Miami, Florida, United States - Emory University
Atlanta, Georgia, United States - (and 27 more...)
|
|
| 14 |
NCT02669849 |
Active, not recruiting |
Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury |
- Cervical Spinal Cord Injury
|
- Drug: VX-210
- Drug: Placebo
|
Interventional
|
Phase 2
Phase 3 |
- Vertex Pharmaceuticals Incorporated
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in upper extremity motor score (UEMS)
- Spinal Cord Independence Measure (SCIM) III Self-Care subscore
- Capabilities of Upper Extremity Test (CUE-T) score
- (and 6 more...)
|
71 |
All |
14 Years to 75 Years (Child, Adult, Older Adult) |
NCT02669849 |
VX15-210-101 |
|
February 2016 |
December 2018 |
December 2018 |
February 1, 2016 |
November 21, 2018 |
|
- Birmingham, Alabama, United States
- Tucson, Arizona, United States
- Fresno, California, United States
- (and 36 more...)
|
|
| 15 |
NCT01683838 |
Completed
Has Results |
Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury |
- Spinal Cord Injury
- Muscle Spasticity
|
- Drug: Fampridine-SR
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
- Double-blind Change From Baseline in Mean Subject's Global Impression (SGI) Scores
- Double-blind Change From Baseline in Mean Spasm Frequency/Severity Scores
- (and 6 more...)
|
204 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01683838 |
SCI-F302 |
|
June 2002 |
November 2003 |
February 2004 |
September 12, 2012 |
August 25, 2017 |
February 5, 2014 |
- UAB School of Medicine, 190 Spain Rehab Center
Birmingham, Alabama, United States - Long Beach VA Medical Center
Long Beach, California, United States - University of California, Davis
Sacramento, California, United States - (and 27 more...)
|
|
| 16 |
NCT00041717 |
Completed
Has Results |
Safety and Efficacy of Oral Fampridine-SR for the Treatment of Spasticity Resulting From Spinal Cord Injury |
- Spinal Cord Injury
- Muscle Spasticity
|
- Drug: Fampridine-SR
- Other: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Double-blind Change From Baseline in Ashworth Score Evaluating Spasticity
- Double-blind Change From Baseline in Subject's Global Impression (SGI) of Treatment
|
213 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00041717 |
SCI-F301 |
|
July 2002 |
February 2004 |
May 2004 |
July 16, 2002 |
May 31, 2013 |
May 31, 2013 |
- Lakeshore Rehabilitation Hospital
Birmingham, Alabama, United States - Barrow Neurological Institute
Phoenix, Arizona, United States - Baptist Medical Center
Little Rock, Arkansas, United States - (and 42 more...)
|
|
| 17 |
NCT02163876 |
Terminated |
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury |
- Cervical Spinal Cord Injury
- Spine Injury
- Cervical Spine Injury
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in ISNCSCI upper extremity motor scores
- Number of participants with serious and non-serious adverse events
|
31 |
All |
18 Years to 60 Years (Adult) |
NCT02163876 |
CL-SCI-201 |
|
October 2014 |
May 2016 |
May 2016 |
June 16, 2014 |
June 2, 2016 |
|
- Rancho Los Amigos National Rehabilitation Center/USC
Downey, California, United States - University of Miami Miller School of Medicine
Miami, Florida, United States - Northwestern University
Chicago, Illinois, United States - (and 11 more...)
|
|
| 18 |
NCT02658656 |
Recruiting |
Powered Exoskeletons in Persons With SCI |
|
|
Interventional
|
Not Applicable |
- VA Office of Research and Development
|
U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mental Health Component Summary (MCS) of the Veterans Rand-36 (VR-36)
- The sum T-score for the SCI-QOL Physical Medical Health domain (three item banks of Bladder Management Difficulties, Bowel Management Difficulties, and Pain Interference)
|
160 |
All |
18 Years and older (Adult, Older Adult) |
NCT02658656 |
2003 |
(PEPSCI) |
August 1, 2016 |
June 30, 2021 |
August 31, 2021 |
January 20, 2016 |
October 26, 2018 |
|
- VA Long Beach Healthcare System, Long Beach, CA
Long Beach, California, United States - VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, United States - James A. Haley Veterans' Hospital, Tampa, FL
Tampa, Florida, United States - (and 8 more...)
|
|
| 19 |
NCT00047580 |
Completed |
Comparison of Safety and Efficacy of Tizanidine Hydrochloride Capsules Versus Zanaflex® (Tizanidine Hydrochloride Tablets) Taken While in the Fed State (Just After a Meal) and in the Fasted State (Before a Meal) in Patients With Moderate to Severe Spasticity. |
- Multiple Sclerosis
- Muscle Spasticity
- Spinal Cord Injury
- Stroke
|
- Drug: tizanidine hydrochloride capsule
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT00047580 |
ELN021-502 |
|
June 2002 |
|
September 2002 |
October 10, 2002 |
December 14, 2015 |
|
- Radiant Research
Tucson, Arizona, United States - The Neurology Center
Encinitas, California, United States - Northridge Neurological Center
Northridge, California, United States - (and 13 more...)
|
|
| 20 |
NCT02943915 |
Recruiting |
The WISE Trial - Walking Improvement for SCI With Exoskeleton |
|
- Device: Ekso GT Rehabilitation Therapy
- Device: Body Weight Supported (BWS) Treadmill Training
|
Interventional
|
Not Applicable |
- Ekso Bionics
- Burke Medical Research Institute
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- 10 Meter Walk Test (10MWT)
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exam - Full Exam for Classification
- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Exam - Full Exam for Scoring
- (and 28 more...)
|
164 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02943915 |
105333 |
WISE |
September 2016 |
September 2019 |
December 2019 |
October 25, 2016 |
August 9, 2018 |
|
- Barrow Neurological Institute at St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States - Gaylord Hospital
Wallingford, Connecticut, United States - Shirley Ryan AbilityLab
Chicago, Illinois, United States - (and 7 more...)
|
|
| 21 |
NCT00318591 |
Completed
Has Results |
Comparative Study of Intermittent Catheters and Occurrence of Urinary Tract Infections |
|
- Device: SpeediCath
- Device: Conveen Uncoated
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Occurrence of Symptomatic Urinary Tract Infections (UTIs)
- UTIs With Bacteriuria >=100 Colony Forming Units (CFU)/ml
- Nurse Evaluation of Catheters - Overall Satisfaction
- (and 4 more...)
|
219 |
All |
18 Years and older (Adult, Older Adult) |
NCT00318591 |
DK046CC |
|
April 2006 |
October 2009 |
October 2009 |
April 27, 2006 |
August 24, 2015 |
May 25, 2011 |
- Rancho Los Amigos National Rehabilitation Center
Downey, California, United States - Santa Clara Valley Medical Center
San Jose, California, United States - Craig Hospital
Englewood, Colorado, United States - (and 13 more...)
|
|
| 22 |
NCT00634426 |
Completed |
Surgical Versus Nonoperative Treatment of Metastatic Epidural Spinal Cord Compression |
- Metastatic Epidural Spinal Cord Compression
|
- Procedure: Surgical excision of the metastatic process
- Radiation: Radiotherapy of the metastatic spine process
|
Observational
|
|
- AOSpine North America Research Network
- AOSpine North America
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in spine-associated pain intensity (BPI) measured by Brief Pain Inventory
- Neurological outcomes measured by American Spinal Injury Association (ASIA) Motor Scale structured clinical examination
- Survival
- (and 5 more...)
|
163 |
All |
18 Years and older (Adult, Older Adult) |
NCT00634426 |
1011 |
MESCC |
March 2008 |
March 2013 |
March 2013 |
March 13, 2008 |
May 21, 2015 |
|
- University of Kansas Medical Center
Kansas City, Kansas, United States - Johns Hopkins University
Baltimore, Maryland, United States - Mayo Clinic
Rochester, Minnesota, United States - (and 7 more...)
|
|
| 23 |
NCT03626324 |
Recruiting |
Connected Catheter (C2P) Study for Bladder Management |
- Urinary Retention
- Neurogenic Bladder
|
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Freedom from genito-urinary injury/trauma
- Successful Acute Performance- I
- Successful Acute Performance- II
- (and 2 more...)
|
80 |
Male |
18 Years and older (Adult, Older Adult) |
NCT03626324 |
C2P-01 |
|
July 25, 2018 |
July 31, 2019 |
September 30, 2019 |
August 13, 2018 |
September 12, 2018 |
|
- Northwest Urology Associates, 9151 West Thunderbird Rd, Suite 104
Peoria, Arizona, United States - Northwest Urology Associates, 14674 W. Mountain View Blvd, Suite 210
Surprise, Arizona, United States - West Coast Urology, 11411 Brookshire Avenue, Suite 508
Downey, California, United States - (and 5 more...)
|
|
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