Parkinson's DiseaseNCT01575132
Deep Brain Stimulation Follow-up After 10 Years
An observational study of Parkinson's Disease, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS) for patients with Parkinson's Disease. We have data for patients operated with DBS since 1998. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2012to Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Parkinson-patients treated with Deep Brain Stimulation at Aarhus University Hospital in the years 1998-2002.
Who may be able to join
- Patients with Parkinson's Disease treated with DBS at Aarhus University Hospital in the years 1998-2002.
Who cannot join
- Dementia, i.e. MMSE<24
- DBS removed
- Deceased
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Aarhus University Hospital, Department of Neurology
Aarhus, 8000
About this study
Official title: STN-DBS Retrospective/Prospective Study With a Follow-up Time of Minimum 10 Years
The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS) for patients with Parkinson's Disease. We have data for patients operated with DBS since 1998. We wish to examine the effect of stimulation on motor symptoms as well as make a follow-up on complications and side-effects related to treatment. We also wish to follow-up on the quality of life-studies made in the years 2003-2008.
Read the detailed description
Parkinson's Disease (PD) is caused by a progressive loss of dopamine-producing cells in substantia nigra in mesencephalon.
PD is characterized by the symptoms resting tremor, rigidity and bradykinesia. Later in the course of the disease, patients develop gait- and balance symptoms. In the first years of the disease, the patients' symptoms are treated well with levodopa. As the disease develops and the loss of dopamine-producing cells grows, the physiological buffer-capacity for levodopa is lost and patients develop motor fluctuations in the shape of on-off symptoms and dyskinesias. Patients with these symptoms may benefit from implantation of electrodes in the subthalamic nucleus, which is stimulated by an pulse generator on the chest.
A number of studies have found a long-term effect of DBS, but most of these studies have a follow-up time of no more than five years. Overall, these studies show a beneficial effect of DBS after five years: The patients need less medication, the number of off-periods is decreased and they score lower on the Unified Parkinson Disease Rating Scale, part three. However, the axial symptoms and the bradykinesia progress.
As of yet, few studies examine the effect of Deep Brain Stimulation after 10 years. In our study we wish to examine the effect of DBS for all patients operated at Aarhus University Hospital in the years 1998-2002, which gives us a follow-up time of 10-14 years.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Stimulation, Deep Brain, Study, Follow-Up, Adverse Effects
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Disease, DBS, 10-14 years | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014 (estimated)
- Study completionSep 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Ostergaard, DMSci, PhD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575132
- Sponsor's protocol ID
- 1-10-72-106-12
- Status last verified
- Nov 2012
- First submitted
- 10 Apr 2012
- Last updated
- 11 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STN-DBS Retrospective/Prospective Study With a Follow-up Time of Minimum 10 Years
- ClinicalTrials.gov ID
- NCT01575132
- Acronym / sponsor ID
- 1-10-72-106-12
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Stimulation, Deep Brain, Study, Follow-Up, Adverse Effects
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Sep 2015 (estimated)
- First posted
- 11 Apr 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.
The purpose of this study is to examine the long-term effect of Deep Brain Stimulation (DBS) for patients with Parkinson's Disease. We have data for patients operated with DBS since 1998. We wish to examine the effect of stimulation on motor symptoms as well as make a follow-up on complications and side-effects related to treatment. We also wish to follow-up on the quality of life-studies made in the years 2003-2008.
Detailed description
Parkinson's Disease (PD) is caused by a progressive loss of dopamine-producing cells in substantia nigra in mesencephalon.
PD is characterized by the symptoms resting tremor, rigidity and bradykinesia. Later in the course of the disease, patients develop gait- and balance symptoms. In the first years of the disease, the patients' symptoms are treated well with levodopa. As the disease develops and the loss of dopamine-producing cells grows, the physiological buffer-capacity for levodopa is lost and patients develop motor fluctuations in the shape of on-off symptoms and dyskinesias. Patients with these symptoms may benefit from implantation of electrodes in the subthalamic nucleus, which is stimulated by an pulse generator on the chest.
A number of studies have found a long-term effect of DBS, but most of these studies have a follow-up time of no more than five years. Overall, these studies show a beneficial effect of DBS after five years: The patients need less medication, the number of off-periods is decreased and they score lower on the Unified Parkinson Disease Rating Scale, part three. However, the axial symptoms and the bradykinesia progress.
As of yet, few studies examine the effect of Deep Brain Stimulation after 10 years. In our study we wish to examine the effect of DBS for all patients operated at Aarhus University Hospital in the years 1998-2002, which gives us a follow-up time of 10-14 years.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease, DBS, 10-14 years | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Parkinson-patients treated with Deep Brain Stimulation at Aarhus University Hospital in the years 1998-2002.
Key inclusion criteria (1 listed)
- Patients with Parkinson's Disease treated with DBS at Aarhus University Hospital in the years 1998-2002.
Key exclusion criteria (3 listed)
- Dementia, i.e. MMSE<24
- DBS removed
- Deceased
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2013.
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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.
Karen Ostergaard, DMSci, PhD principal investigator
Aarhus University Hospital
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 Parkinson's Disease, run by University of Aarhus at 1 site in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 11 Dec 2013. 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 Denmark. 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?
Results are not available in the source record.
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.
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 11 Dec 2013.