Parkinson DiseasePDdictedNCT01705418
Behavior Addictions Improvement in Parkinson Disease's Patients Treated by Subthalamic Stimulation : Long Term Follow-up
An observational study of Parkinson Disease, run by University Hospital, Grenoble.
Trial summary
Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Jun 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: Parkinson's desesase patients included in another protocol evaluating Apathy after deep brain stimulation.
Who may be able to join
- Patients included in the protocol 'Apathy'
Who cannot join
- NA
About this study
Official title: Behavior Addictions Improvement in Parkinson Disease's Patients Treated by
Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up
Read the detailed description
Whereas subthalamic nucleus (STN) stimulation is considered an established treatment for motor symptoms in advanced Parkinson's disease (PD), its behavioral and psychiatric effects are strongly debated, with some studies showing a worsening or new onset of behavioral and psychiatric issues after STN stimulation and other showing an improvement. However, these data are based mainly on case reports and retrospective series.
Recently, the investigators group has conducted a prospective study assessing behavior and psychiatric symptoms in patients undergoing STN stimulation up to one year after surgery. After subthalamic stimulation non-motor fluctuations improved and pathologic hyperdopaminergic syndrome, i.e. behavioral addictions (including pathological gambling, hypersexuality, binge eating, compulsive shopping, …), compulsive use of dopaminergic treatment and dopaminergic dysregulation syndrome (defined as the association of one or more behavioral addictions to compulsive use of dopaminergic treatment), disappeared. These findings represent a milestone because, if confirmed, the indications of STN stimulation might be extended beyond motor complications. To date, there are several long-term studies on motor and cognitive effects of STN stimulation, whereas no long-term longitudinal data on neuropsychiatric effects do exist. Therefore, the investigators designed a long-term prospective study, assessing over 3-8 years behavioral and psychiatric effect in the same cohort of patients included in the one-year study. This study will allow to better evaluate the change in non-motor fluctuations and of behavioral issues in the long-term with a standard management.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Deep brain stimulation, behavior and psychiatric symptoms improvement
- Medical subject headings
- Parkinson Disease, Behavior
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01705418
- Sponsor's protocol ID
- 12PHR02
- Acronym
- PDdicted
- Status last verified
- Oct 2012
- First submitted
- 9 Oct 2012
- Last updated
- 9 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abbes M, Lhommee E, Thobois S, Klinger H, Schmitt E, Bichon A, Castrioto A, Xie J, Fraix V, Kistner A, Pelissier P, Seigneuret E, Chabardes S, Mertens P, Broussolle E, Moro E, Krack P. Subthalamic stimulation and neuropsychiatric symptoms in Parkinson's disease: results from a long-term follow-up cohort study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):836-843. doi: 10.1136/jnnp-2017-316373. Epub 2018 Feb 7.
PubMed 29436490
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Addictions Improvement in Parkinson Disease's Patients Treated by
- ClinicalTrials.gov ID
- NCT01705418
- Acronym / sponsor ID
- PDdicted / 12PHR02
- Conditions
- Parkinson Disease
- Keywords
- Parkinson disease, Deep brain stimulation, behavior and psychiatric symptoms improvement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 12 Oct 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.
Improvement of behavioral addictions in STN-DBS in PD: Long term follow-up
Detailed description
Whereas subthalamic nucleus (STN) stimulation is considered an established treatment for motor symptoms in advanced Parkinson's disease (PD), its behavioral and psychiatric effects are strongly debated, with some studies showing a worsening or new onset of behavioral and psychiatric issues after STN stimulation and other showing an improvement. However, these data are based mainly on case reports and retrospective series.
Recently, the investigators group has conducted a prospective study assessing behavior and psychiatric symptoms in patients undergoing STN stimulation up to one year after surgery. After subthalamic stimulation non-motor fluctuations improved and pathologic hyperdopaminergic syndrome, i.e. behavioral addictions (including pathological gambling, hypersexuality, binge eating, compulsive shopping, …), compulsive use of dopaminergic treatment and dopaminergic dysregulation syndrome (defined as the association of one or more behavioral addictions to compulsive use of dopaminergic treatment), disappeared. These findings represent a milestone because, if confirmed, the indications of STN stimulation might be extended beyond motor complications. To date, there are several long-term studies on motor and cognitive effects of STN stimulation, whereas no long-term longitudinal data on neuropsychiatric effects do exist. Therefore, the investigators designed a long-term prospective study, assessing over 3-8 years behavioral and psychiatric effect in the same cohort of patients included in the one-year study. This study will allow to better evaluate the change in non-motor fluctuations and of behavioral issues in the long-term with a standard management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Parkinson's desesase patients included in another protocol evaluating Apathy after deep brain stimulation.
Key inclusion criteria (1 listed)
- Patients included in the protocol 'Apathy'
Key exclusion criteria (1 listed)
- NA
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
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 9 Mar 2016.
- Derived from this study: PubMed 29436490Abbes M, Lhommee E, Thobois S, Klinger H, Schmitt E, Bichon A, Castrioto A, Xie J, Fraix V, Kistner A, Pelissier P, Seigneuret E, Chabardes S, Mertens P, Broussolle E, Moro E, Krack P. Subthalamic stimulation and neuropsychiatric symptoms in Parkinson's disease: results from a long-term follow-up cohort study. J Neurol Neurosurg Psychiatry. 2018 Aug;89(8):836-843. doi: 10.1136/jnnp-2017-316373. Epub 2018 Feb 7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by University Hospital, Grenoble.
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 1 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 9 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01705418, which also lists 1 linked publication.
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 9 Mar 2016.