Movement DisorderNCT00610233
Effect of Deep Brain Stimulation on Lower Urinary Tract Function
A study testing deep brain stimulation ON and Deep brain stimulation OFF in people with Movement Disorder and Urinary Tract Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique opportunity to investigate the role of different cerebral centers on LUT function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Movement Disorder, Urinary Tract Disease
- What is being tested?
- deep brain stimulation ON and Deep brain stimulation OFF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2005to Jun 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with deep brain stimulation (DBS)
Who cannot join
- Pregnancy
- Age <18 years
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Department of Neurology, University of Bern
Bern, 3010
Department of Urology, University of Bern
Bern, 3010
About this study
Official title: Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function
The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique opportunity to investigate the role of different cerebral centers on LUT function.
We hypothesize that DBS has a significant effect on LUT function and that these effects depend on the specific stimulated cerebral center.
- Conditions
- Movement Disorder, Urinary Tract Disease
- Being tested
- deep brain stimulation ON, Deep brain stimulation OFF
- Keywords
- deep brain stimulation, urodynamics
- Medical subject headings
- Movement Disorders, Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep brain stimulation ONProcedure or surgery
deep brain stimulation in the ON state
Deep brain stimulation OFFProcedure or surgery
Urodynamic investigation with deep brain stimulation in the OFF state
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Urodynamic investigation with deep brain stimulation ON Receives: Procedure: deep brain stimulation ON |
| B | Experimental | Urodynamics with deep brain stimulation OFF Receives: Procedure: Deep brain stimulation OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of deep brain stimulation (DBS) on urodynamic parameters
Measured: immediately and 3 months after study inclusion
Secondary outcomes (1)
Changes in questionnaire data due to deep brain stimulation (DBS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJun 2005
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Movement DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Thomas M Kessler, MD, Principal investigator, Department of Urology, University of Bern, 3010 Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610233
- Sponsor's protocol ID
- KEK 33/05
- Other IDs
- 1005
- Status last verified
- Sep 2014
- First submitted
- 24 Jan 2008
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function
- ClinicalTrials.gov ID
- NCT00610233
- Acronym / sponsor ID
- KEK 33/05
- Conditions
- Movement Disorder, Urinary Tract Disease
- Keywords
- deep brain stimulation, urodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 7 Feb 2008 (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.
The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique opportunity to investigate the role of different cerebral centers on LUT function.
We hypothesize that DBS has a significant effect on LUT function and that these effects depend on the specific stimulated cerebral center.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: deep brain stimulation ONUrodynamic investigation with deep brain stimulation ON |
| B | Experimental | Procedure: Deep brain stimulation OFFUrodynamics with deep brain stimulation OFF |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with deep brain stimulation (DBS)
Key exclusion criteria (2 listed)
- Pregnancy
- Age <18 years
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 |
|---|---|---|
| deep brain stimulation ONdeep brain stimulation in the ON state | Procedure or surgery | A |
| Deep brain stimulation OFFUrodynamic investigation with deep brain stimulation in the OFF state | Procedure or surgery | B |
Primary outcome
Effect of deep brain stimulation (DBS) on urodynamic parameters
Time frame: immediately and 3 months after study inclusion
1 secondary outcome
Changes in questionnaire data due to deep brain stimulation (DBS)
Time frame: 3 months
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 19 Sep 2014.
Related trials for Movement Disorder
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
RecruitingObservational study
Multimodal Characterization of Movement Trajectories in Chronic Inflammatory Demyelinating Polyneuropathy
CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
RecruitingObservational study
Parkinson's Disease in Type 1 Gaucher Disease
Parkinson Disease (PD), Type 1 Gaucher Disease
RecruitingPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform
Progressive Supranuclear Palsy(PSP)
Recruiting
24 Gy in One Fraction Urethral-sparing "HDR Like" SBRT for Prostate Cancer
Localized Prostate Carcinoma
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.
Thomas M Kessler, MD principal investigator
Department of Urology, University of Bern, 3010 Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep brain stimulation ON and Deep brain stimulation OFF in people with Movement Disorder and Urinary Tract Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites 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 1 inclusion and 2 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 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effect of deep brain stimulation (DBS) on urodynamic parameters (time frame: immediately and 3 months after study inclusion). 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 19 Sep 2014.