Parkinson's DiseaseNCT02893449
Psychiatry Study: Parkinson Disease
A study testing Social adaptation, Intensive care management and Deep brain stimulation in people with Parkinson's Disease, run by Central Hospital, Nancy, France at 3 sites in France.
Trial summary
Main objective: To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Social adaptation, Intensive care management and Deep brain stimulation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2009to Nov 2015
- 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
- Men or women suffering from idiopathic Parkinson's disease for which the indication of treatment by deep cerebral stimulation is retained
- Obtained informed consent
Who cannot join
- Absence of social security
- Patient unable to be compliant
- Major patient under guardianship
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Clermont Ferrand
Clermont-Ferrand, 63003
CHU de Nancy
Nancy, 54035
CHRU Strasbourg
Strasbourg, 67426
About this study
Official title: Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation
Main objective:
To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation.
Secondary objectives:
To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.
Read the detailed description
Prospective, longitudinal, controlled, multicentric, randomised, open study.
Subjects: 3 groups of 40 patients (n=120): one group of patients profiting from a structured program of preoperative cognitive remediation (SICRPPD group: Specific Individual Cognitive Remediation Program in Parkinson's Disease), one group of patients profiting from a preoperative non structured accompaniment (ICM group: Intensive Care Management), one control group (CG group: Control Group).
Required sample size: The sample size of 40 patients/group will allow to demonstrate with a significance threshold of 5% and a power of 80% a difference of evolution of the global SAS SR score of 0.75 SD between 2 of the 3 groups. For an intended SD of 0.2 units, the threshold corresponds to a difference of 0.15 units, minimal significant change.
Intervention: The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.
Evaluation tools: Patients will be met before and after the intervention for clinical evaluations and scales making: For the psychiatric evaluation: Mini International Neuropsychiatric Inventory (M.I.N.I.), Starkstein Apathy Scale, Montgomery and Asberg depression scale (MADRS), global functioning evaluation scale (EGF) and Hamilton anxiety scale (HAMA)/ For the social adaptation evaluation: Social Adjustment scale Self Report (SAS SR)/ For quality of life evaluation: 39-item Parkinson's Disease Questionnaire (PDQ-39)/ For the daily life activities, 'motor' symptomatology and treatment complications evaluation: Unified Parkinson's Disease Rating Scale (UPDRS, parties II, III, et IV).
Main criteria: change in the global score of the SAS SR scale.
Secondary Criteria: change in scores of the PDQ-39 (quality of life), HAMA (anxiety), Starkstein (apathy), MADRS (mood), EGF (psychologic, social, professional functioning, and depending on the psychiatric symptomatology) questionnaires.
Statistics: parametric and non parametric tests will be done for p < 0.05.
- Conditions
- Parkinson's Disease
- Being tested
- Social adaptation, Intensive care management, Deep brain stimulation
- Keywords
- Parkinson, SAS-SR, Social adaptation, Patients suffering from Parkinson's disease
- Medical subject headings
- Parkinson Disease, Social Adjustment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social adaptationBehavioural
Questionnaire to fill-in.
The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.
Intensive care managementBehavioural
In this group, the structured program of the SICRPPD group will be replaced by 3 unstructured psychiatric interviews during which patients will be assessed for their perception of the disease and the upcoming surgery. This group will allow to control for the intrinsic effect of the preoperative management independently of the remediation itself.
Deep brain stimulationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| SICRPPD group | Other | (Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation Receives: Behavioral: Social adaptation; Procedure: Deep brain stimulation |
| ICM group: Intensive Care Management | Other | Group of patients profiting from a preoperative non structured support Receives: Behavioral: Intensive care management; Procedure: Deep brain stimulation |
| CG group: Control Group | Other | No supplementary support Receives: Procedure: Deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global score of the SAS SR (social adjustment scale self report) scale
Measured: 3 months (after surgery)
Global score of the SAS SR (social adjustment scale self report) scale
Measured: 6 months (after surgery)
Secondary outcomes (20)
Quality of life
evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)
Measured: 3 months
Quality of life
evaluated with WHOQOL-bref (World Health Organization Quality of Life)
Measured: 3 months
Quality of life
evaluated with PDQ-39 (39-item Parkinson's Disease Questionnaire)
Measured: 6 months
Quality of life
evaluated with WHOQOL-bref (World Health Organization Quality of Life)
Measured: 6 months
Anxiety
evaluated with HAMA (Hamilton Anxiety Rating Scale)
Measured: 3 months
Anxiety
evaluated with HAMA (Hamilton Anxiety Rating Scale)
Measured: 6 months
Apathy
evaluated with Starkstein scale
Measured: 3 months
Apathy
evaluated with Starkstein scale
Measured: 6 months
Mood
evaluated with Montgomery-Åsberg depression rating scale
Measured: 3 months
Mood
evaluated with Montgomery-Åsberg depression rating scale
Measured: 6 months
Global Assessment of Functioning
to rate the social, occupational, and psychological functioning according to psychiatric symptomatology
Measured: 3 months
Global Assessment of Functioning
to rate the social, occupational, and psychological functioning according to psychiatric symptomatology
Measured: 6 months
Disease perception
Illness Perception Questionnaire Revised
Measured: 3 months
Disease perception
Illness Perception Questionnaire Revised
Measured: 6 months
Perception of deep brain stimulation
with Perception of deep brain stimulation scale
Measured: 3 months
Perception of deep brain stimulation
with Perception of deep brain stimulation scale
Measured: 6 months
Coping with disease
with CHIP scale
Measured: 3 months
Coping with disease
with Brief COPE scale
Measured: 3 months
Coping with disease
with CHIP scale
Measured: 6 months
Coping with disease
with Brief COPE scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study startApr 2009
- Primary completionNov 2015
- Study completionNov 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'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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymund Schwan, Prof., Principal investigator, Nancy's HospitalGérard Barroche, Prof., Principal investigator, CHU of Nancy - Central Hospital - Bd Marechal de Lattre de Tassigny - 54000 NancyMarie-Christine Tranchant, Prof., Principal investigator, CHU of Strasbourg - 67000 StrasbourgFranck Durif, Prof, Principal investigator, CHU Clermont-Ferrand - 63000 Clermont Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02893449
- Sponsor's protocol ID
- PSY PARKINSON
- Status last verified
- Sep 2016
- First submitted
- 5 Feb 2010
- Last updated
- 8 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Meyer M, Colnat-Coulbois S, Frismand S, Vidailhet P, Llorca PM, Schwan R, Spitz E. Illness perceptions in pre-operative Parkinson's disease patients. J Neural Transm (Vienna). 2023 May;130(5):647-654. doi: 10.1007/s00702-023-02629-2. Epub 2023 Apr 6.
PubMed 37022502
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Social Adaptation After Pre-operative Cognitive Remediation in Parkinson's Patients Profiting From a Bilateral Subthalamic Stimulation
- ClinicalTrials.gov ID
- NCT02893449
- Acronym / sponsor ID
- PSY PARKINSON
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson, SAS-SR, Social adaptation, Patients suffering from Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 8 Sep 2016 (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.
Main objective:
To assess the impact of a structured program of preoperative cognitive remediation on postoperative social adaptation in patients suffering from Parkinson's disease profiting from bilateral subthalamic nucleus stimulation.
Secondary objectives:
To assess in the same patients the impact of structured program of preoperative cognitive remediation on quality of life, mood, anxiety, apathy and psychologic, social and professional functioning depending on psychiatric symptomatology after intervention.
Detailed description
Prospective, longitudinal, controlled, multicentric, randomised, open study.
Subjects: 3 groups of 40 patients (n=120): one group of patients profiting from a structured program of preoperative cognitive remediation (SICRPPD group: Specific Individual Cognitive Remediation Program in Parkinson's Disease), one group of patients profiting from a preoperative non structured accompaniment (ICM group: Intensive Care Management), one control group (CG group: Control Group).
Required sample size: The sample size of 40 patients/group will allow to demonstrate with a significance threshold of 5% and a power of 80% a difference of evolution of the global SAS SR score of 0.75 SD between 2 of the 3 groups. For an intended SD of 0.2 units, the threshold corresponds to a difference of 0.15 units, minimal significant change.
Intervention: The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program.
Evaluation tools: Patients will be met before and after the intervention for clinical evaluations and scales making: For the psychiatric evaluation: Mini International Neuropsychiatric Inventory (M.I.N.I.), Starkstein Apathy Scale, Montgomery and Asberg depression scale (MADRS), global functioning evaluation scale (EGF) and Hamilton anxiety scale (HAMA)/ For the social adaptation evaluation: Social Adjustment scale Self Report (SAS SR)/ For quality of life evaluation: 39-item Parkinson's Disease Questionnaire (PDQ-39)/ For the daily life activities, 'motor' symptomatology and treatment complications evaluation: Unified Parkinson's Disease Rating Scale (UPDRS, parties II, III, et IV).
Main criteria: change in the global score of the SAS SR scale.
Secondary Criteria: change in scores of the PDQ-39 (quality of life), HAMA (anxiety), Starkstein (apathy), MADRS (mood), EGF (psychologic, social, professional functioning, and depending on the psychiatric symptomatology) questionnaires.
Statistics: parametric and non parametric tests will be done for p < 0.05.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SICRPPD group | Other | Behavioral: Social adaptation, Procedure: Deep brain stimulation(Specific Individual Cognitive Remediation Program in Parkinson's Disease). Group of patients profiting from a structured program of preoperative cognitive remediation |
| ICM group: Intensive Care Management | Other | Behavioral: Intensive care management, Procedure: Deep brain stimulationGroup of patients profiting from a preoperative non structured support |
| CG group: Control Group | Other | Procedure: Deep brain stimulationNo supplementary support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men or women suffering from idiopathic Parkinson's disease for which the indication of treatment by deep cerebral stimulation is retained
- Obtained informed consent
Key exclusion criteria (3 listed)
- Absence of social security
- Patient unable to be compliant
- Major patient under guardianship
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 |
|---|---|---|
| Social adaptationQuestionnaire to fill-in. The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program. | Behavioural | SICRPPD group |
| Intensive care managementIn this group, the structured program of the SICRPPD group will be replaced by 3 unstructured psychiatric interviews during which patients will be assessed for their perception of the disease and the upcoming surgery. This group will allow to control for the intrinsic effect of the preoperative management independently of the remediation itself. | Behavioural | ICM group: Intensive Care Management |
| Deep brain stimulation | Procedure or surgery | CG group: Control Group, ICM group: Intensive Care Management, SICRPPD group |
Primary outcome
Global score of the SAS SR (social adjustment scale self report) scale
Time frame: 3 months (after surgery)
Global score of the SAS SR (social adjustment scale self report) scale
Time frame: 6 months (after surgery)
20 secondary outcomes
Quality of life
Time frame: 3 months
Quality of life
Time frame: 3 months
Quality of life
Time frame: 6 months
Quality of life
Time frame: 6 months
Anxiety
Time frame: 3 months
Anxiety
Time frame: 6 months
Apathy
Time frame: 3 months
Apathy
Time frame: 6 months
Mood
Time frame: 3 months
Mood
Time frame: 6 months
Global Assessment of Functioning
Time frame: 3 months
Global Assessment of Functioning
Time frame: 6 months
Disease perception
Time frame: 3 months
Disease perception
Time frame: 6 months
Perception of deep brain stimulation
Time frame: 3 months
Perception of deep brain stimulation
Time frame: 6 months
Coping with disease
Time frame: 3 months
Coping with disease
Time frame: 3 months
Coping with disease
Time frame: 6 months
Coping with disease
Time frame: 6 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 8 Sep 2016.
- Derived from this study: PubMed 37022502Meyer M, Colnat-Coulbois S, Frismand S, Vidailhet P, Llorca PM, Schwan R, Spitz E. Illness perceptions in pre-operative Parkinson's disease patients. J Neural Transm (Vienna). 2023 May;130(5):647-654. doi: 10.1007/s00702-023-02629-2. Epub 2023 Apr 6.
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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.
Raymund Schwan, Prof. principal investigator
Nancy's Hospital
Gérard Barroche, Prof. principal investigator
CHU of Nancy - Central Hospital - Bd Marechal de Lattre de Tassigny - 54000 Nancy
Marie-Christine Tranchant, Prof. principal investigator
CHU of Strasbourg - 67000 Strasbourg
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Social adaptation, Intensive care management and Deep brain stimulation in people with Parkinson's Disease, run by Central Hospital, Nancy, France at 3 sites in France.
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 2 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: finished, as of the sponsor's last update on 8 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Global score of the SAS SR (social adjustment scale self report) scale (time frame: 3 months (after surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02893449, 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 8 Sep 2016.