Mild Cognitive ImpairmentNCT01600404
Effects of Antimuscarinics on Cognition in Spinal Cord Injury
An observational study of Mild Cognitive Impairment and Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Cognitive Impairment, Spinal Cord Injuries
- What is being tested?
- antimuscarinic treatment
- How many people
- 32 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2011to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
About this study
Official title: Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Spinal Cord Injuries
- Being tested
- antimuscarinic treatment
- Keywords
- Mild Cognitive Impairment, Muscarinic Antagonists, Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Overactive Detrusor
- Medical subject headings
- Cognitive Dysfunction, Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antimuscarinic treatmentDrug
| Study group | Role | What they receive |
|---|---|---|
| antimuscarinic treatment | antimuscarinic treatment Receives: Drug: antimuscarinic treatment | |
| no antimuscarinic treatment (control) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
d2 Test
Measured: change from enrollement to 3 months
Secondary outcomes (16)
International Spinal Cord Injury Pain Basic Data Set
Measured: day 0 and at 3 months
Beck Depression Inventory Score
Measured: day 0 and at 3 months
patient characteristics
age
Measured: day 0
type of neurologic lower urinary tract dysfunction
Measured: day 0
Stroop Test
Measured: day 0 and at 3 months
California Verbal Learning Test
Measured: day 0 and at 3 months
Verbal Fluency Test according to Thurstone
Measured: day 0 and at 3 months
visuospatial performance
subtests from Wechsler Adult Intelligence Scale
Measured: day 0 and at 3 months
divided attention
subtests from test battery according to Zimmermann and Fimm
Measured: day 0 and at 3 months
patient characteristics
sex
Measured: day 0
patient characteristics
date of injury
Measured: day 0
patient characteristics
tpe of accident
Measured: day 0
patient characteristics
Glasgow Coma Scale
Measured: day 0
patient characteristics
lesion level
Measured: day 0
patient characteristics
completeness of injury
Measured: day 0
patient characteristics
ASIA impairment score
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startDec 2011
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jürgen Pannek, Prof, Principal investigator, Swiss Paraplegic Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600404
- Sponsor's protocol ID
- 2011-25
- Status last verified
- Nov 2015
- First submitted
- 10 May 2012
- Last updated
- 17 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antimuscarinic Drugs on the Cognition of Patients With Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01600404
- Acronym / sponsor ID
- 2011-25
- Conditions
- Mild Cognitive Impairment, Spinal Cord Injuries
- Keywords
- Mild Cognitive Impairment, Muscarinic Antagonists, Spinal Cord Injuries, Urinary Bladder, Neurogenic, Urinary Bladder, Overactive, Overactive Detrusor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- Dec 2011
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antimuscarinic treatment | – | Drug: antimuscarinic treatmentantimuscarinic treatment |
| no antimuscarinic treatment (control) | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute (4-8 week post-injury) traumatic spinal cord injury during first rehabilitation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- lesion level above C4
- traumatic brain injury (initial Glasgow Coma Score < 13)
- pre-existing dementia
- pre-existing impaired cognitive function
- previous antimuscarinic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antimuscarinic treatment | Drug | antimuscarinic treatment |
Primary outcome
d2 Test
Time frame: change from enrollement to 3 months
16 secondary outcomes
International Spinal Cord Injury Pain Basic Data Set
Time frame: day 0 and at 3 months
Beck Depression Inventory Score
Time frame: day 0 and at 3 months
patient characteristics
Time frame: day 0
type of neurologic lower urinary tract dysfunction
Time frame: day 0
Stroop Test
Time frame: day 0 and at 3 months
California Verbal Learning Test
Time frame: day 0 and at 3 months
Verbal Fluency Test according to Thurstone
Time frame: day 0 and at 3 months
visuospatial performance
Time frame: day 0 and at 3 months
divided attention
Time frame: day 0 and at 3 months
patient characteristics
Time frame: day 0
patient characteristics
Time frame: day 0
patient characteristics
Time frame: day 0
patient characteristics
Time frame: day 0
patient characteristics
Time frame: day 0
patient characteristics
Time frame: day 0
patient characteristics
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jürgen Pannek, Prof principal investigator
Swiss Paraplegic Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Spinal Cord Injuries, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
d2 Test (time frame: change from enrollement to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2015.