Idiopathic Parkinson's DiseaseNCT00664157
Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus
A study testing Facial expression recognition of emotion in people with Idiopathic Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Parkinson's Disease
- What is being tested?
- Facial expression recognition of emotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2007to Oct 2009
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age : 30-75 years
- Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank" (Hughes et al., 1992)
- Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
- Effect of the stimulation 50%
- Affiliation to social security
- Agreement of patients
Who cannot join
- Patients suffering of an atypical Parkinson syndrome
- Patients with severe tremor before surgery
- Patients with a vision contrast altered.
- Patients who do not understand the words associated with an emotion
- Pregnant women
- Person who participate to an other study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus .
Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus is now considered the gold standard surgical treatment.
Parkinson'disease mainly affects the nigrostriatal dopaminergic system which is linked to the limbic system and could be responsible of a specific trouble in the recognition in some facial expression.
Read more
We hypothesise that patients with Parkinson'disease present a dysfunction of voluntary and automatic treatment of emotional information.
The main purpose of this study is to show if patients with Parkinson'disease present a lack of specific facial expression recognition of emotion and determinate more precisely if this alteration involves the cortical way (high frequency way) or the under cortical way (low frequency way).
We also examine the role of L-Dopa and the deep brain stimulation on emotion perception
Read the detailed description
40 patients with an Idiopathic Parkinson's disease divided in two groups :
- 20 patients evaluated before surgery and 6 month after surgery
- 20 patients only evaluated after surgery. 40 paired healthy volunteers
- Study progress (patients):
Inclusion visit :
Neurological evaluations .
Neuropsychological evaluations : MMS, MADRS, MATTIS, BREF, Wisconsin test, Apathy test, Benton….
Ophthalmic visit : VISTECH
Protocol :
- for patients evaluated before surgery Facial expression recognition test Lexical decision test Made in two conditions : without the treatment (Med OFF) and one hour after the L-Dopa administration (MED ON)
- for patients evaluated after surgery Facial expression recognition test Lexical decision test Made in four conditions
- Without stimulation (STIM OFF) and medication (MED OFF)
- MED OFF and STIM ON
- MED ON and STIM OFF
- MED ON and STIM ON
- Study progress (healthy volunteers): Ophthalmic visit MMS Facial expression recognition test Lexical decision test
- Conditions
- Idiopathic Parkinson's Disease
- Being tested
- Facial expression recognition of emotion
- Keywords
- Idiopathic Parkinson's disease, L-Dopa, Deep Brain stimulation, Facial expression recognition of emotion, Frequency levels, Automatic and voluntary information treatment, Patient with an Idiopathic Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial expression recognition of emotionBehavioural
Facial expression recognition test Lexical decisiontest
Facial expression recognition of emotionBehavioural
Facial expression recognition test Lexical decision test
| Study group | Role | What they receive |
|---|---|---|
| 2 | Other | 40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group) Receives: Behavioral: Facial expression recognition of emotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial expression recognition test
Measured: % of exact responses
Secondary outcomes (1)
Lexical decision test
Measured: The time to respond
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionOct 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Investigators
- Franck Durif, PUPH, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664157
- Sponsor's protocol ID
- CHU-0033
- Other IDs
- RBHP 2007 Durif
- Status last verified
- Jan 2011
- First submitted
- 21 Apr 2008
- Last updated
- 19 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facial Expression Recognition of Emotion and Categorization of Emotional Words in Parkinson's Disease. Impact of L-Dopa and Deep Brain Stimulation of Subthalamic Nucleus .
- ClinicalTrials.gov ID
- NCT00664157
- Acronym / sponsor ID
- CHU-0033
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Idiopathic Parkinson's disease, L-Dopa, Deep Brain stimulation, Facial expression recognition of emotion, Frequency levels, Automatic and voluntary information treatment, Patient with an Idiopathic Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 22 Apr 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.
Parkinson'disease is a neurodegenerative disorder characterised by bradykinesia, rigidity, rest tremor and postural instability. Dopaminergic therapy such as L-Dopa and dopamine agonists usually leads to a dramatic improvement of symptoms, but disease progression nevertheless remains inevitable. Bilateral Deep brain stimulation in subthalamic nucleus is now considered the gold standard surgical treatment.
Parkinson'disease mainly affects the nigrostriatal dopaminergic system which is linked to the limbic system and could be responsible of a specific trouble in the recognition in some facial expression.
We hypothesise that patients with Parkinson'disease present a dysfunction of voluntary and automatic treatment of emotional information.
The main purpose of this study is to show if patients with Parkinson'disease present a lack of specific facial expression recognition of emotion and determinate more precisely if this alteration involves the cortical way (high frequency way) or the under cortical way (low frequency way).
We also examine the role of L-Dopa and the deep brain stimulation on emotion perception
Detailed description
40 patients with an Idiopathic Parkinson's disease divided in two groups :
- 20 patients evaluated before surgery and 6 month after surgery
- 20 patients only evaluated after surgery. 40 paired healthy volunteers
- Study progress (patients):
Inclusion visit :
Neurological evaluations .
Neuropsychological evaluations : MMS, MADRS, MATTIS, BREF, Wisconsin test, Apathy test, Benton….
Ophthalmic visit : VISTECH
Protocol :
- for patients evaluated before surgery Facial expression recognition test Lexical decision test Made in two conditions : without the treatment (Med OFF) and one hour after the L-Dopa administration (MED ON)
- for patients evaluated after surgery Facial expression recognition test Lexical decision test Made in four conditions
- Without stimulation (STIM OFF) and medication (MED OFF)
- MED OFF and STIM ON
- MED ON and STIM OFF
- MED ON and STIM ON
- Study progress (healthy volunteers): Ophthalmic visit MMS Facial expression recognition test Lexical decision test
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Other | Behavioral: Facial expression recognition of emotion40 patients with an idiopathic Parkinson's disease and 40 healthy paired volunteers (control group) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age : 30-75 years
- Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank" (Hughes et al., 1992)
- Patient treated with a deep brain stimulation according to the French consensus conference of treatment of Parkinson's disease (Consensus Conference Proceeding, 2000)
- Effect of the stimulation 50%
- Affiliation to social security
Key exclusion criteria (6 listed)
- Patients suffering of an atypical Parkinson syndrome
- Patients with severe tremor before surgery
- Patients with a vision contrast altered.
- Patients who do not understand the words associated with an emotion
- Pregnant women
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 |
|---|---|---|
| Facial expression recognition of emotionFacial expression recognition test Lexical decisiontest | Behavioural | 2 |
| Facial expression recognition of emotionFacial expression recognition test Lexical decision test | Behavioural | 2 |
Primary outcome
Facial expression recognition test
Time frame: % of exact responses
1 secondary outcome
Lexical decision test
Time frame: The time to respond
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 Jan 2011.
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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.
Franck Durif, PUPH principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial expression recognition of emotion in people with Idiopathic Parkinson's Disease, run by University Hospital, Clermont-Ferrand at 1 site 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 6 inclusion and 6 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 Jan 2011. 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 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?
Facial expression recognition test (time frame: % of exact responses). 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 Jan 2011.