Treatment for Chronic Spinal Cord Injury: Surgery With Rehabilitation vs Rehabilitation

Kunming Tongren Hospital

Status: Unknown

Conditions: Spinal Cord Injuries

Treatments: Procedure: Surgery; Procedure: Rehabilitation

Study type: Interventional

Funder types: NETWORK; Industry; Other

Identifiers

NCT02663310

KunmingTH_HZ_001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Surgery with Rehabilitation

Experimental group

Description:

Surgically removed cysts, and collected intracystic fluids and cerebrospinal fluid for histological and molecular analyses. Samples will be collected during the surgery and will be cryo-protected for further analyses. All subjects will enroll for intensive rehabilitation 60 days after surgery.

Treatment:

Procedure: Rehabilitation

Procedure: Surgery

Rehabilitation

Active Comparator group

Description:

All subjects will enroll for intensive rehabilitation everyday as instruction.

Treatment:

Procedure: Rehabilitation