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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01241630
First Posted: November 16, 2010
Last Update Posted: May 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Lundbeck Foundation
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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 Intervention
Spinal Cord Injury Procedure: Somatosensory reflex arch (Xiao Procedure)

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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


Enrollment: 10
Study Start Date: November 2009
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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 Submitted: November 8, 2010
First Posted: November 16, 2010
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