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Effects of Antimuscarinics on Cognition in Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Swiss Paraplegic Centre Nottwil
Sponsor:
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier:
NCT01600404
First received: May 10, 2012
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

Prospective evaluation of the cognitive function of in-house patients suffering from an acute traumatic spinal cord injury before and three months after the initiation of antimuscarinic treatment.

The following hypothesis will be tested: Antimuscarinic treatment results in significantly worse cognitive test results three months after traumatic spinal cord injury compared to the pre-treatment results and the results of the control group.


Condition Intervention
Mild Cognitive Impairment
Spinal Cord Injuries
Drug: antimuscarinic treatment

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by Swiss Paraplegic Centre Nottwil:

Primary Outcome Measures:
  • d2 Test [ Time Frame: change from enrollement to 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • International Spinal Cord Injury Pain Basic Data Set [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
  • Beck Depression Inventory Score [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    age

  • type of neurologic lower urinary tract dysfunction [ Time Frame: day 0 ] [ Designated as safety issue: No ]
  • Stroop Test [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
  • California Verbal Learning Test [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
  • Verbal Fluency Test according to Thurstone [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
  • visuospatial performance [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
    subtests from Wechsler Adult Intelligence Scale

  • divided attention [ Time Frame: day 0 and at 3 months ] [ Designated as safety issue: No ]
    subtests from test battery according to Zimmermann and Fimm

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    sex

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    date of injury

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    tpe of accident

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    Glasgow Coma Scale

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    lesion level

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    completeness of injury

  • patient characteristics [ Time Frame: day 0 ] [ Designated as safety issue: No ]
    ASIA impairment score


Estimated Enrollment: 40
Study Start Date: December 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
antimuscarinic treatment
antimuscarinic treatment
Drug: antimuscarinic treatment
no antimuscarinic treatment (control)

Detailed Description:

There will be two groups: 1) patients receiving antimuscarinic treatment 2) patients without antimuscarinic treatment (control).

The control group will be investigated in order to determine the effects of traumatic spinal cord injury on cognition and the natural history of potential cognitive impairment within the first three months after spinal cord injury.

Six to eight weeks after traumatic spinal cord injury, patients are examined in order to determine the type of neurogenic bladder dysfunction they are suffering from. Patients suffering from an overactive bladder will receive antimuscarinic treatment in order to prevent high urine storage and voiding pressures, that put the kidneys at risk.

Prior to the urologic examination, patients fulfilling inclusion criteria will be contacted. If informed consent is given, cognitive function will be evaluated in both patient groups using different standard neuropsychologic tests. The same neuropsychologic tests will be repeated three months later. Evaluation will take place under standardized conditions (e.g. time of day).

Furthermore,different factors influencing cognition, e.g. depression, pain, medication, will be assessed at the beginning and end of the study.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation

Criteria

Inclusion Criteria:

  • acute traumatic spinal cord injury
  • primary rehabilitation / in-house patient
  • 18-65 years of age
  • treatment group: indication for antimuscarinic treatment (oxybutynin, tolterodine
  • willingness and motivation to participate in study

Exclusion Criteria:

  • lesion level above C4
  • traumatic brain injury (initial Glasgow Coma Score < 13)
  • pre-existing dementia
  • pre-existing impaired cognitive function
  • previous antimuscarinic treatment
  • treatment group: antimuscarinic treatment other than oxybutynin, tolterodine
  • acute psychologic disorders, diseases, schizophrenia
  • alcohol abuse, consumption of illegal drugs (incl. marijuana)
  • moderate to severe depression (Beck Depression Inventory Score > 18)
  • moderate to severe pain (International Spinal Cord Injury Pain Basic Data Set)
  • progressive disease
  • tricyclic antidepressant
  • color blindness, impaired sight, blindness
  • insufficient German language skills
  • no informed consent
  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: NCT01600404

Contacts
Contact: Jürgen Pannek, Prof +41419395922 jürgen.pannek@paranet.ch

Locations
Switzerland
Swiss Paraplegic Centre Recruiting
Nottwil, LU, Switzerland, 6207
Contact: Jürgen Pannek, Prof    +41419395922    jürgen.pannek@paranet.ch   
Principal Investigator: Jürgen Pannek, Prof         
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Investigators
Principal Investigator: Jürgen Pannek, Prof Swiss Paraplegic Centre
  More Information

No publications provided

Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT01600404     History of Changes
Other Study ID Numbers: 2011‐25
Study First Received: May 10, 2012
Last Updated: October 7, 2014
Health Authority: Switzerland: Ethikkommission

Keywords provided by Swiss Paraplegic Centre Nottwil:
Mild Cognitive Impairment
Muscarinic Antagonists
Spinal Cord Injuries
Urinary Bladder, Neurogenic
Urinary Bladder, Overactive
Overactive Detrusor

Additional relevant MeSH terms:
Spinal Cord Injuries
Cognition Disorders
Mild Cognitive Impairment
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries
Muscarinic Antagonists
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014