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Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Clinical Outcome

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ClinicalTrials.gov Identifier: NCT01241630
Recruitment Status : Completed
First Posted : November 16, 2010
Last Update Posted : May 12, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Spinal cord injury (SCI) usually affects young people and causes severe bowel and bladder dysfunction. Recently, the concept of a surgically created somat-sensory reflex arch for bladder dysfunction in SCI has been introduced. The concept is promising, not just for bladder but also for bowel dysfunction. However, well designed studies need to be performed before recommending the procedure to a large number of patients worldwide. In this study we perform multidisciplinary studies providing necessary information about the clinical outcome of the somato-sensory reflex arch in adult SCI patients.

The hypothesis is as follows:

  1. In a "western setting" the somato-sensory reflex arch can be created in adult SCI patients with only minor morbidity and complications.
  2. Somato-sensory reflex arch reduces bladder and bowel symptoms in SCI patients.

Condition or disease Intervention/treatment
Spinal Cord Injury Procedure: Somatosensory reflex arch (Xiao Procedure)

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Somato-sensory Reflex Arch in Spinal Cord Injury - Effect on Clinical Outcome
Study Start Date : November 2009
Primary Completion Date : September 2013
Study Completion Date : September 2013

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Arms and Interventions

Intervention Details:
    Procedure: Somatosensory reflex arch (Xiao Procedure)
    Cross over surgery. Proximal part of L5 Ventral root is anastomosed to distal part of ventral root of S2 or S3 producing a somato-sensory reflex arch
    Other Names:
    • Somato-sensory reflex arch
    • Artificial somato-sensory reflex arch

Outcome Measures

Primary Outcome Measures :
  1. Urodynamic function and bladder symptoms before and after somato-autonomic reflex arch in spinal cord injury patients [ Time Frame: 2013 (anticipated) ]
    Prospective study of urodynamic function and bladder symptoms before and after somato-autonomic reflex arch in spinal cord injury patients.


Secondary Outcome Measures :
  1. Colorectal symptoms before and after somato-autonomic reflex arch in spinal cord injury patients [ Time Frame: 2013 (anticipated) ]
    Prospective study of colorectal symptoms before and after somato-autonomic reflex arch in spinal cord injury patients.

  2. Colorectal transit times and rectal wall properties after somato-autonomic reflex arch in spinal cord injury patient [ Time Frame: 2013 (anticipated) ]
    Prospective study of colorectal transit times and rectal wall properties after somato-autonomic reflex arch in spinal cord injury patients.

  3. Effect of quality of Life after somato-autonomic reflex arch in spinal cord injury patient [ Time Frame: 2013 (anticipated) ]
    Effect of quality of Life after somato-autonomic reflex arch in spinal cord injury patient


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or above with motoric complete
  • Spinal cord injury medullary level C4-L4
  • Preserved Hamstring reflex (L5)
  • Participation acceptance in verbal and writing

Exclusion Criteria:

  • Respiratory dependent patient Baclofen pump Malignancy in the urinary tract, surgery on the urinary tract, urethral strictures Ileostomy, Colostomy or radiation towards the area Pregnancy, for men planning a pregnancy with their partner
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241630


Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Lundbeck Foundation
Investigators
Principal Investigator: Klaus Krogh, MD,PhD, DmSc Aarhus University Hospital
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01241630     History of Changes
Other Study ID Numbers: M-20090113 - 2
First Posted: November 16, 2010    Key Record Dates
Last Update Posted: May 12, 2014
Last Verified: October 2012

Keywords provided by University of Aarhus:
Somato-sensory reflex arch
Spinal cord injury
Xiao Procedure

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System