Clinical trial NCT02663310: Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation
Official title: Surgical Decompression/Untethering Combined With Weight Bearing Rehabilitation in Chronic Spinal Cord Injury Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: spinal cord injury
Kunming Locomotor Scale
surgical decompression
untethering
weight bearing rehabilitation
Lead sponsor: Kunming Tongren Hospital
Sponsor class: INDUSTRY
Collaborators: name: Hong Kong Spinal Cord Injury Fund
name: China Spinal Cord Injury Network
First posted: 2016-01-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.

Detailed description: Safety Issues:

Safety issues need to be watched are: occurrence of known and unknown undesirable incidences, moving up injury levels, loss of previously preserved neurological functions, vital physical signs, and worsening of EKG and lab results. If unforeseen issues occur, patients will be consulted to determine whether treatments will be continued.

Adverse events:

Adverse events may occur during the trail and these events will be recorded. The severity of the events and their relationship to the experimental therapy will be determined, documented and reported to the Data Monitoring and Safety Committee who will determine how these events will be handled if they occur.

Eligibility criteria: Inclusion Criteria:

* Male or female adult subjects, 18-60 years of age
* Have a clinical diagnosis of chronic spinal cord injury (≥ 12 months after traumatic spinal cord injury).
* Neurological examination: ASIA-A
* Injury levels: T1-T12 spinal levels
* The diagnosis of spinal cord injury is confirmed by MRI
* Subjects must be able to read, write and complete visual analogue scale
* Voluntarily signs and dates an informed Consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures. If a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process.

Exclusion Criteria:

* Severe head injury
* Subjects with severe osteoporosis or joint diseases
* Subjects with severe pressure sore
* Sign of kidney, cardiovascular, liver disorders
* Subjects with internal medical and/or infectious diseases (including but not limited to Hepatitis B and HIV carriers)
* Pregnant women or women at lactation stages
* Medically or mentally unstable according to the judgment of the investigator
* History of multiple sclerosis or peripheral demyelination
* Any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Primary outcomes:
measure: Change of Kunming Locomotor Scale in 1 year
timeFrame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Secondary outcomes:
measure: Change of Walking Index for Spinal Cord Injury in 1 year
timeFrame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
measure: Change of Spinal Cord Independence Measure in 1 year
timeFrame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
measure: Change of American Spinal Injury Association Impairment Scale in 1 year
timeFrame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
measure: Change of Modified Ashworth Scale in 1 year
timeFrame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
measure: Change of Numerical Rating Scale in 1 year
timeFrame: Day 0, Day 15, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, and 1 year
Other outcomes:
Locations:
city: Kunming
country: China
facility: Kunming Tongren Hospital
state: Yunnan
Study officials:
affiliation: Kunming Tongren Hospital
name: Hui Zhu, MD
role: PRINCIPAL_INVESTIGATOR
References: