Parkinson DiseaseES-ParkNCT05433441
Evaluation of the Effectiveness of the Parkinson Specialized Teams Intervention
A study testing ESPark Intervention in people with Parkinson Disease, run by University Hospital, Bordeaux at 4 sites in France.
Trial summary
A pilot experiment interventional study is proposed in order to set up multidisciplinary team for Parkinson's patients at home. The aim of this study is to evaluate the effectiveness of this specialized Parkinson's team (ESPark) intervention a on the quality of life of patients with moderate to severe Parkinson's… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- ESPark Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Dec 2022to 6 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For the patient:
- Patient with a diagnosis of idiopathic Parkinson's disease
- Patient over 18 years ;
- Patient with a Hoehn and Yahr Stage greater than or equal to 3;
- Patient without major cognitive impairment defined by a MOCA score ≥21
- Patient living at home ;
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- Patient with an identified non-professional primary caregiver;
- Person affiliated with or benefiting from a social security plan;
- Free, informed and and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).
- For the caregiver:
- Male or female over 18 years
- Able to respond to research interviews/questionnaires
- Free, informed and express consent (confirmed in writing) (no later than the day of inclusion and before any examination required by the research).
Who cannot join
- For the patient:
- Patient with medically indicated dementia impairing comprehension and adherence, and/or with severe confusion or psycho-hallucinatory state;
- Institutionalized or foster care patients;
- Patients with a known severe and unstable general pathology that does not allow for patient follow-up;
- Patients already included in another non-drug management trial;
- Patients whose institutionalization is envisaged in the short term (within 6 months) or for whom a change of residence is envisaged in the short term and would not allow for follow-up assessments;
Show all 16Show fewer
- Patients under guardianship or unable to express consent
- Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
- Presence of a primary caregiver with a known severe and unstable disease that does not allow for the conduct of the study;
- Presence of a primary caregiver with a known cognitive or psychiatric disorder (chronic progressive psychosis) that does not allow for the proper conduct of the study.
- Pregnant or breastfeeding woman.
- For the caregiver:
- Unable to follow the research interviews or questionnaires.
- Primary caregiver not wishing to participate in the study or unable to be available for the planned study follow-up;
- Primary caregiver with a known severe and unstable illness that does not allow for the proper conduct of the study;
- Primary caregiver with known cognitive or psychiatric disorders (chronic progressive psychosis) that do not allow the study to be conducted properly.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Hopital Pellegrin
Bordeaux, 33000
Alexandra FOUBERT-SAMIER, Dr, alexandra.samier-foubert@u-bordeaux.fr
- Recruiting
CHU de Lille
Lille, 59037
Nicolas CARRIERE, Dr, 0320446752, nicolas.carriere@chu-lille.fr
- Recruiting
CHU de Limoges
Limoges, 87042
Jean-Luc HOUETO, Pr, jean-luc.houeto@chu-limoges.fr
- Recruiting
CHU Poitiers
Poitiers, 90577
Isabelle BENATRU, Dr, isabelle.benatru@chu-poitiers.fr
About this study
Official title: Evaluation of the Effectiveness of the Parkinson's Specialized Teams Intervention on the Quality of Life of Parkinson's Patients in the Territory of the Nouvelle-Aquitaine and Hauts-de-France: ES-Park Pilot Study.
A pilot experiment interventional study is proposed in order to set up multidisciplinary team for Parkinson's patients at home. The aim of this study is to evaluate the effectiveness of this specialized Parkinson's team (ESPark) intervention a on the quality of life of patients with moderate to severe Parkinson's disease
Read the detailed description
Parkinson's disease (PD) and related disorders are the second most common cause of motor disability in the elderly after stroke. Progressively, the disability impacts the activities of daily living and social life of Parkinson's patients with a major impact on their quality of life. The diversity and complexity of the needs of parkinsonian patients and their caregivers justify a specific multidisciplinary approach. Several studies have evaluated the effectiveness of the intervention of such teams on the maintenance of activities of daily living and quality of life of Parkinson's patients with contradictory results. In France, the experience of specialized Alzheimer teams (ESA) based on the same concept seems to have brought positive results on autonomy and resocialization. Based on the positive experience of ESA intervention in Alzheimer's disease and in view of the data in the literature on Parkinson's disease, we would like to develop the same type of care with teams adapted to the problems of Parkinson's disease patients, which we could call ESParks, and to evaluate the effectiveness of such teams in the context of support for Parkinson's patients.
- Conditions
- Parkinson Disease
- Being tested
- ESPark Intervention
- Keywords
- Parkinson, Quality of life, Complementary non drug intervention, Multidisciplinary approach
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESPark InterventionProcedure or surgery
The treatment will include 15 sessions (1 session per week). An initial assessment will be carried out during the first session in order to determine the objectives and the personalized follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Not described |
| ESPark Intervention | Experimental | Under medical prescription and in addition to medical and physiotherapy care, the ESPark will intervene in an ecological way with Parkinson's patients in order to rehabilitate them, maintain their autonomy in their daily life and their social life with the aim of improving the quality of life of the patient and his main caregiver. Beyond a rehabilitative intervention in the home, the ESPark's mission would also be to optimize the patient's living environment and possibly help with the implementation of the necessary aids in the continuity of medical care. Receives: Procedure: ESPark Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of quality of life scale (PDQ 39)
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
Measured: Initial Visit - Day 0
Score of quality of life scale (PDQ 39)
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
Measured: 6 months
Secondary outcomes (36)
IADL assessment
Assessment of the level of dependence in instrumental activities of daily living It consists of 9 items with a total score that varies from 0 to 36 Each item is scored from 0 (autonom) to 4 (no autonom) or NA
Measured: Initial Visit - Day 0
IADL assessment
Assessment of the level of dependence in instrumental activities of daily living
Measured: 6 months
IADL assessment
Assessment of the level of dependence in instrumental activities of daily living
Measured: 12 months
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Measured: Initial Visit - Day 0
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Measured: 6 months
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Used to evaluate the various motor and non-motor symptoms. In this protocol, only motor examination will be carried out. This part includes the following items: speech, facial expression, rigidity, finger tapping, hand movements, hand pronation supination movements, toe tapping, leg agility, getting up from the examination chair, walking, postural stability, posture, overall spontaneity of movement, postural hand tremor, hand action tremor, amplitude of resting tremor, constancy of resting tremor. The items of the Parkinsonian triad are evaluated on the different parts of the body (extremities of the limbs, lip and jaw for resting tremor and neck for rigidity). The presence of dyskinesias is mentioned at the end of the evaluation and if they interfered with the motor examination, as well as the global scale of Hoehn and Yahr. All items are rated from 0 to 4 and are clearly defined : 0: normal, 1 = minimal, 2 = mild, 3 = moderate, 4 = severe
Measured: 12 months
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Measured: Initial Visit - Day 0
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Measured: 6 months
Non-motor symptoms Scale for Parkinson's Disease (NMSS) score
30-item scale that assesses a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions. The scale can be used for patients in all stages of PD.
Measured: 12 months
Montreal Cognitive Assessment (MOCA) score
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Measured: Initial Visit - Day 0
Montreal Cognitive Assessment (MOCA) score
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Measured: 6 months
Montreal Cognitive Assessment (MOCA) score
The MoCA assesses mild cognitive dysfunction. It assesses the following functions: short-term memory, visual-spatial skills, executive functions, attention, concentration, working memory, language, abstraction, calculation and orientation in time and space. Cognitive impairment is assessed using a 30-point score (27-30: no cognitive impairment; 18-26: mild; 10-17: moderate; < 10: severe).
Measured: 12 months
Beck Depression Inventory (BDI-II) score
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Measured: Initial Visit - Day 0
Beck Depression Inventory (BDI-II) score
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Measured: 6 months
Beck Depression Inventory (BDI-II) score
Self-questionnaire comprising a list of 21 items measuring the somatic, affective and cognitive severity of depressive symptoms. Each item is rated for symptom severity and/or frequency, over the past 7 days, on a 4-point scale ranging from 0 to 3. Higher scores indicate severe symptomatology.
Measured: 12 months
Parkinson Anxiety Scale (PAS) Score
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Measured: Initial Visit - Day 0
Parkinson Anxiety Scale (PAS) Score
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Measured: 6 months
Parkinson Anxiety Scale (PAS) Score
Self-questionnaire assessing anxiety in Parkinson's disease dealing with several dimensions of anxiety: Persistent anxiety (5 items), Episodic anxiety (4 items), Avoidance behavior (3 items). Each item is scored from 0 (not at all) to 4 (strongly or almost always).
Measured: 12 months
Reduced Neuropsychiatric Inventory (NPI-R) score
Used to assesses 12 domains of psychobehavioral disorders (21). It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Measured: Initial Visit - Day 0
Reduced Neuropsychiatric Inventory (NPI-R) score
Used to assesses 12 domains of psychobehavioral disorders (21). It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Measured: 6 months
Reduced Neuropsychiatric Inventory (NPI-R) score
Used to assesses 12 domains of psychobehavioral disorders. It is a questionnaire consisting of a screening question and seven to nine items for each of the 12 domains: delusions, hallucinations, agitation/aggressiveness, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor aberration, behavioural disorders, sleep, appetite and eating. The score ranges from 0 to 144 .
Measured: 12 months
Zarit scale score
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Measured: Initial Visit - Day 0
Zarit scale score
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Measured: 6 Months
Zarit scale score
This scale assesses caregiver burden ; it consists of 22 items with a total score that varies from 0 to 88. (score ≤20, no burden - score> 60, severe burden).
Measured: 12 Months
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
Measured: Initial Visit - Day 0
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
Measured: 6 months
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
This anxiety scale consists of 2 scales of 20 questions that assess how subjects feel at the time and generally.
Measured: 12 months
Quality of life as measured by the PQoL Carers.
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Measured: Initial Visit - Day 0
Quality of life as measured by the PQoL Carers.
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Measured: 6 months
Quality of life as measured by the PQoL Carers.
Quality of life questionnaire for caregivers Self-questionnaire comprising a list of 26 items with a total score that varies from 0 to 104
Measured: 12 months
Sense of competence questionnaire
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Measured: Initial Visit - Day 0
Sense of competence questionnaire
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Measured: 6 months
Sense of competence questionnaire
This 35-item questionnaire covers three areas: the impact of caregiving on the caregiver's personal life, satisfaction with one's own performance as a caregiver, and satisfaction with the person with dementia as a recipient of care Each item is scored from 1 ("yes") to 3 ("No") and 2 (Yes/no) The total score varies from 27 to 81
Measured: 12 months
Ressource Utilization in Dementia (RUD)
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Measured: Initial Visit - Day 0
Ressource Utilization in Dementia (RUD)
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Measured: 6 Months
Ressource Utilization in Dementia (RUD)
The questionnaire allows us to estimate the medico-social costs associated with the care of the patient. This estimate is based on the evaluation of the quantity of formal resources (including social services, home care) and informal resources (care and assistance provided by the caregiver) involved in the day-to-day care of the patient; the resources are valued economically using the health insurance rates, where applicable, and the hourly costs of medical and social assistance at home
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start6 Dec 2022
- Primary completion6 Dec 2025 (estimated)
- Study completion6 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexandra FOUBERT-SAMIER, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433441
- Sponsor's protocol ID
- CHUBX 2022/02
- Acronym
- ES-Park
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of the Parkinson's Specialized Teams Intervention on the Quality of Life of Parkinson's Patients in the Territory of the Nouvelle-Aquitaine and Hauts-de-France: ES-Park Pilot Study.
- ClinicalTrials.gov ID
- NCT05433441
- Acronym / sponsor ID
- ES-Park / CHUBX 2022/02
- Conditions
- Parkinson Disease
- Keywords
- Parkinson, Quality of life, Complementary non drug intervention, Multidisciplinary approach
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 6 Dec 2025 (estimated)
- Study completion
- 6 Jun 2027 (estimated)
- First posted
- 27 Jun 2022 (actual)
- 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.
A pilot experiment interventional study is proposed in order to set up multidisciplinary team for Parkinson's patients at home. The aim of this study is to evaluate the effectiveness of this specialized Parkinson's team (ESPark) intervention a on the quality of life of patients with moderate to severe Parkinson's disease
Detailed description
Parkinson's disease (PD) and related disorders are the second most common cause of motor disability in the elderly after stroke. Progressively, the disability impacts the activities of daily living and social life of Parkinson's patients with a major impact on their quality of life. The diversity and complexity of the needs of parkinsonian patients and their caregivers justify a specific multidisciplinary approach. Several studies have evaluated the effectiveness of the intervention of such teams on the maintenance of activities of daily living and quality of life of Parkinson's patients with contradictory results. In France, the experience of specialized Alzheimer teams (ESA) based on the same concept seems to have brought positive results on autonomy and resocialization. Based on the positive experience of ESA intervention in Alzheimer's disease and in view of the data in the literature on Parkinson's disease, we would like to develop the same type of care with teams adapted to the problems of Parkinson's disease patients, which we could call ESParks, and to evaluate the effectiveness of such teams in the context of support for Parkinson's patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | – |
| ESPark Intervention | Experimental | Procedure: ESPark InterventionUnder medical prescription and in addition to medical and physiotherapy care, the ESPark will intervene in an ecological way with Parkinson's patients in order to rehabilitate them, maintain their autonomy in their daily life and their social life with the aim of improving the quality of life of the patient and his main caregiver. Beyond a rehabilitative intervention in the home, the ESPark's mission would also be to optimize the patient's living environment and possibly help with the implementation of the necessary aids in the continuity of medical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient with a diagnosis of idiopathic Parkinson's disease
- Patient over 18 years ;
- Patient with a Hoehn and Yahr Stage greater than or equal to 3;
- Patient without major cognitive impairment defined by a MOCA score ≥21
- Patient living at home ;
Key exclusion criteria (16 listed)
- Patient with medically indicated dementia impairing comprehension and adherence, and/or with severe confusion or psycho-hallucinatory state;
- Institutionalized or foster care patients;
- Patients with a known severe and unstable general pathology that does not allow for patient follow-up;
- Patients already included in another non-drug management trial;
- Patients whose institutionalization is envisaged in the short term (within 6 months) or for whom a change of residence is envisaged in the short term and would not allow for follow-up assessments;
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 |
|---|---|---|
| ESPark InterventionThe treatment will include 15 sessions (1 session per week). An initial assessment will be carried out during the first session in order to determine the objectives and the personalized follow-up. | Procedure or surgery | ESPark Intervention |
Primary outcome
Score of quality of life scale (PDQ 39)
Time frame: Initial Visit - Day 0
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
Score of quality of life scale (PDQ 39)
Time frame: 6 months
Self-questionnaire in 39 items evaluating the quality of life of Parkinson's patients from a motor and psychological point of view. Each question is rated from 0 (no disturbance) to 4 (maximum disturbance). The items are divided into 8 dimensions (activity of daily living, emotional well-being, psychological discomfort, social support, cognitive impairment, communication, physical discomfort, mobility) It consists of 39 items with a total score that varies from 0 to 154
36 secondary outcomes
IADL assessment
Time frame: Initial Visit - Day 0
IADL assessment
Time frame: 6 months
IADL assessment
Time frame: 12 months
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Time frame: Initial Visit - Day 0
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Time frame: 6 months
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Rate
Time frame: 12 months
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
Time frame: Initial Visit - Day 0
Non-motor symptoms Scale for Parkinson's Disease (NMSS)
Time frame: 6 months
Non-motor symptoms Scale for Parkinson's Disease (NMSS) score
Time frame: 12 months
Montreal Cognitive Assessment (MOCA) score
Time frame: Initial Visit - Day 0
Montreal Cognitive Assessment (MOCA) score
Time frame: 6 months
Montreal Cognitive Assessment (MOCA) score
Time frame: 12 months
Beck Depression Inventory (BDI-II) score
Time frame: Initial Visit - Day 0
Beck Depression Inventory (BDI-II) score
Time frame: 6 months
Beck Depression Inventory (BDI-II) score
Time frame: 12 months
Parkinson Anxiety Scale (PAS) Score
Time frame: Initial Visit - Day 0
Parkinson Anxiety Scale (PAS) Score
Time frame: 6 months
Parkinson Anxiety Scale (PAS) Score
Time frame: 12 months
Reduced Neuropsychiatric Inventory (NPI-R) score
Time frame: Initial Visit - Day 0
Reduced Neuropsychiatric Inventory (NPI-R) score
Time frame: 6 months
Reduced Neuropsychiatric Inventory (NPI-R) score
Time frame: 12 months
Zarit scale score
Time frame: Initial Visit - Day 0
Zarit scale score
Time frame: 6 Months
Zarit scale score
Time frame: 12 Months
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
Time frame: Initial Visit - Day 0
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
Time frame: 6 months
State Trait Anxiety Inventory short scale (STAI-E and STAI-T) score
Time frame: 12 months
Quality of life as measured by the PQoL Carers.
Time frame: Initial Visit - Day 0
Quality of life as measured by the PQoL Carers.
Time frame: 6 months
Quality of life as measured by the PQoL Carers.
Time frame: 12 months
Sense of competence questionnaire
Time frame: Initial Visit - Day 0
Sense of competence questionnaire
Time frame: 6 months
Sense of competence questionnaire
Time frame: 12 months
Ressource Utilization in Dementia (RUD)
Time frame: Initial Visit - Day 0
Ressource Utilization in Dementia (RUD)
Time frame: 6 Months
Ressource Utilization in Dementia (RUD)
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2025.
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PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
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.
Alexandra FOUBERT-SAMIER principal investigator
University Hospital, Bordeaux
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESPark Intervention in people with Parkinson Disease, run by University Hospital, Bordeaux at 4 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 13 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra FOUBERT-SAMIER, Dr (05 57 82 12 53, alexandra.samier-foubert@u-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of quality of life scale (PDQ 39) (time frame: Initial Visit - Day 0). 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?
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 23 Jul 2025.