Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Neurologic and Neurophysiologic Assessment of Clinical Course in Patients With Intraspinal Processes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2010 by University of Zurich
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT01105520
First received: April 15, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

Patients included in the study are treated at the Klinik für Neurochirurgie USZ. The clinical course is documented at Paraplegikerzentrum Balgrist using validated diagnostic procedures (e.g. SCIM, ASIA, neurophysiology).

Study aims:

Prognostic value of clinical diagnosis and additional diagnostic procedures? Which parameters exhibit optimal prognostic power? Differences between tumor/AVM associated lesions and traumatic lesions? What can we learn for pathophysiology and treatment?

  • Trial with surgical intervention

Condition Intervention Phase
Tumor
Procedure: Diagnostic
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Estimated Enrollment: 100
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Groups/Cohorts Assigned Interventions
intralspinal processes
Patients with intralspinal processes
Procedure: Diagnostic
SCIM Spinal Cord Independence Measure ASIA scale American Spinal Injury Association

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients treated surgically for intraspinal processes

Criteria

Inclusion criteria:

  • Benign intraspinal process (tumor or vascular malformation AVM)
  • Primary lesion caudal of the brainstem, affecting C1
  • Cognitive ability to give written informed consent

Exclusion criteria:

  • Metastases, malign tumors
  • Traumatic lesions
  • Myelitis, polyneuropathy
  • Disc prolaps
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01105520

Contacts
Contact: 01 Studienregister MasterAdmins +41 (0)44 255 11 11

Locations
Switzerland
Recruiting
Zurich, Switzerland
Sponsors and Collaborators
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
  More Information

No publications provided

Responsible Party: Prof. H. Bertalanffy, University of Zurich
ClinicalTrials.gov Identifier: NCT01105520     History of Changes
Other Study ID Numbers: ZU-XYZ-003
Study First Received: April 15, 2010
Last Updated: April 15, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University of Zurich:
Intraspinal processes (tumor or vascular malformation AVM)

ClinicalTrials.gov processed this record on November 20, 2014