Multiple System AtrophyQUA2-AMSNCT04965922
Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy
A study testing Multimodal intervention in people with Multiple System Atrophy, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple System Atrophy
- What is being tested?
- Multimodal intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 17 Jul 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Patients Inclusion Criteria :
- Patients suffering from "possible" or "probable" MSA according to clinical consensus criteria
- Living at home
- Presence of at least one close person (family caregiver or not) in the entourage
- Unified Multiple System Atrophy Rating Scale (UMSARS) IV ≤4
- Written informed consent
- Patient covered by the national health system
Caregivers Inclusion Criteria :
- Age > 18
- Able to answer to study scales and survey
- Written informed consent
Patients Exclusion Criteria:
- Unified Multiple System Atrophy Rating Scale (UMSARS) IV > 4
- Absence of at least one close person
Caregivers Inclusion Criteria :
- Enable to answer to study scales and survey
Trial locations and contacts
1 site in 1 country.
About this study
Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. The aim of the study is to evaluate the effect of a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) on the quality of life of patients and their caregivers.
Read the detailed description
Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder, which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. No effective treatment is available. MSA patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA as other neurodegenerative diseases cause profound declines in functioning ; thus, many patients require caregivers for assistance with daily living. Caregiving can also be extremely stressful, and many caregivers experience declines in mental health. All of these repercussions contribute to the deterioration of the caregiver's quality of life and they can have an impact on the patient, in particular, on the patient's survival. Improving quality of life is a major element and identifying effective targeted interventions would bring immediate and direct benefit to patients and their families. In this context, it seems that a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) developed by Mittelman could contribute to improve disease management and better coping with daily living difficulties. The NYUCI strategy combines sessions of individual and family counseling, support group participation, and additional on-call telephone consultations in a flexible counseling approach that is tailored to each caregiving family
- Conditions
- Multiple System Atrophy
- Being tested
- Multimodal intervention
- Keywords
- Multiple System Atrophy, Quality of life, Multimodal intervention, Neurodegenerative disease
- Medical subject headings
- Multiple System Atrophy, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal interventionBehavioural
The intervention consists of identifying the individual needs of each caregiver and patient and identifying sources of improvement in the management of daily life, including the optimization of social support. This optimization requires the involvement of people in the environment (family, friends, neighbours) who can provide help, support of any kind, recurrent or punctual, minimizing negative family interactions and maximizing positive contributions by each in supporting and supporting the individual.
The intervention is personalized in the sense that the content of each session seeks to adapt itself to the specificities of the couple situation and its surroundings.
interviews/meetings involving a psychologist social worker.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal intervention at inclusion | Experimental | Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers. Receives: Behavioral: Multimodal intervention |
| Multimodal intervention at 6 month | Other | Multimodal intervention will be proposed to Multiple system atrophy patients and their caregivers. Receives: Behavioral: Multimodal intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.
Measured: Day 0
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.
Measured: 6 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.
Measured: 12 month
Secondary outcomes (30)
Center for Epidemiologic Sutdies-Depression (CESD) Score
20 items scale used to assess the existence of a depressive syndrome. Scores less than 15 does not indicate any depressive disorder Scores between 15 and 21 are indicative of mild to moderate depression. Scores above 21 are consistent with the existence of severe/ major depression
Measured: Day 0
Center for Epidemiologic Sutdies-Depression (CESD) Score
20 items scale used to assess the existence of a depressive syndrome. Scores less than 15 does not indicate any depressive disorder Scores between 15 and 21 are indicative of mild to moderate depression. Scores above 21 are consistent with the existence of severe/ major depression
Measured: 3 month
Center for Epidemiologic Sutdies-Depression (CESD) Score
20 items scale used to assess the existence of a depressive syndrome. Scores less than 15 does not indicate any depressive disorder Scores between 15 and 21 are indicative of mild to moderate depression. Scores above 21 are consistent with the existence of severe/ major depression
Measured: 6 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items) and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem) with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analogue scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating lower quality of life).
Measured: Day 0
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items) and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem) with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analogue scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating lower quality of life).
Measured: 3 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Score of other sub-dimension of the MSA Quality of Life scale. The MSA-QoL questionnaire is composed of three different subscales: motor (14 items), non-motor (12 items) and emotional/social (14 items). The response options for each question range from 0 (no problem) to 4 (extreme problem) with higher total scores reflecting more impaired quality of life. The MSA-QoL also includes a visual analogue scale (VAS) of how satisfied patients feel (range 0-100, with lower scores indicating lower quality of life).
Measured: 6 month
State Trait Inventory Anxiety (STAI) Score
Anxiety assessment. 2 scales of 20 questions used to assess how subjects feel at the time and generally. Score > 65 means high anxiety ; Score < 35 means low anxiety
Measured: Day 0
State Trait Inventory Anxiety (STAI) Score
Anxiety assessment. 2 scales of 20 questions used to assess how subjects feel at the time and generally. Score > 65 means high anxiety ; Score < 35 means low anxiety
Measured: 3 month
State Trait Inventory Anxiety (STAI) Score
Anxiety assessment. 2 scales of 20 questions used to assess how subjects feel at the time and generally. Score > 65 means high anxiety ; Score < 35 means low anxiety
Measured: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) I
(0=no disorder, 48=severe disorders): Is an assessment of daily life activities via 12 12 items scale used to assess language, writing, autonomy , walking and the presence of possible urinary, sexual or intestinal disorders. (0=no disorder, 48=severe)
Measured: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) I
(0=no disorder, 48=severe disorders): Is an assessment of daily life activities via 12 12 items scale used to assess language, writing, autonomy , walking and the presence of possible urinary, sexual or intestinal disorders. (0=no disorder, 48=severe)
Measured: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) I
(0=no disorder, 48=severe disorders): Is an assessment of daily life activities via 12 12 items scale used to assess language, writing, autonomy , walking and the presence of possible urinary, sexual or intestinal disorders. (0=no disorder, 48=severe)
Measured: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) II
Motor examination based on 14 items that allow to evaluate in particular facial expression, oculomotricity, oral expression, tremors or walking. 0=no disorder, 56=severe disorders
Measured: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) II
Motor examination based on 14 items that allow to evaluate in particular facial expression, oculomotricity, oral expression, tremors or walking. 0=no disorder, 56=severe disorders
Measured: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) II
Motor examination based on 14 items that allow to evaluate in particular facial expression, oculomotricity, oral expression, tremors or walking. 0=no disorder, 56=severe disorders
Measured: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) III
Blood pressure and heart rate measurements in the lying and standing position for 10 min every minute.
Measured: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) III
Blood pressure and heart rate measurements in the lying and standing position for 10 min every minute.
Measured: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) III
Blood pressure and heart rate measurements in the lying and standing position for 10 min every minute.
Measured: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) IV
Assessment of the disability from 1 to 5. 1 = completely independent ; 5 = totally dependent
Measured: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) IV
Assessment of the disability from 1 to 5. 1 = completely independent ; 5 = totally dependent
Measured: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) IV
Assessment of the disability from 1 to 5. 1 = completely independent ; 5 = totally dependent
Measured: 6 month
Montreal Cognitive Assessment (MoCA) Score
evaluates short-term memory, visuospatial skills, executive functions, attention, concentration, work memory, language, abstraction, computation, and time and space orientation. Cognitive impairment is assessed by the score on 30 points (27-30: no cognitive impairment; 21-26: mild).
Measured: Day 0
Montreal Cognitive Assessment (MoCA) Score
evaluates short-term memory, visuospatial skills, executive functions, attention, concentration, work memory, language, abstraction, computation, and time and space orientation. Cognitive impairment is assessed by the score on 30 points (27-30: no cognitive impairment; 21-26: mild).
Measured: 3 month
Montreal Cognitive Assessment (MoCA) Score
evaluates short-term memory, visuospatial skills, executive functions, attention, concentration, work memory, language, abstraction, computation, and time and space orientation. Cognitive impairment is assessed by the score on 30 points (27-30: no cognitive impairment; 21-26: mild).
Measured: 6 month
Zarit Scale score
Assesses caregiver burden. 22 item scale with total score ranging from 0 to 88. Score 20 mean zero load - Score > 60 means severe load
Measured: Day 0
Zarit Scale score
Assesses caregiver burden. 22 item scale with total score ranging from 0 to 88. Score 20 mean zero load - Score > 60 means severe load
Measured: 3 month
Zarit Scale score
Assesses caregiver burden. 22 item scale with total score ranging from 0 to 88. Score 20 mean zero load - Score > 60 means severe load
Measured: 6 month
Family Relations Index (FRI)
27 items used to assess family functioning : family cohesion, verbalization of feelings and family conflict.
Measured: Day 0
Family Relations Index (FRI)
27 items used to assess family functioning : family cohesion, verbalization of feelings and family conflict.
Measured: 3 month
Family Relations Index (FRI)
27 items used to assess family functioning : family cohesion, verbalization of feelings and family conflict.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Jul 2021
- Primary completion26 Jun 2024
- Study completion17 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple System AtrophyStudies 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
- 130 participants (actual)
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
- NCT04965922
- Sponsor's protocol ID
- CHUBX 2020/29
- Other IDs
- 2020-A01962-37
- Acronym
- QUA2-AMS
- Status last verified
- Jul 2025
- First submitted
- 6 May 2021
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Caregivers and Patients Suffering From Multiple System Atrophy
- ClinicalTrials.gov ID
- NCT04965922
- Acronym / sponsor ID
- QUA2-AMS / CHUBX 2020/29
- Conditions
- Multiple System Atrophy
- Keywords
- Multiple System Atrophy, Quality of life, Multimodal intervention, Neurodegenerative disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 26 Jun 2024 (actual)
- Study completion
- 17 Jul 2025 (actual)
- First posted
- 16 Jul 2021 (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.
Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder that cause as other neurodegenerative diseases profound declines in functioning and thus, require caregiving for assistance with daily living. The aim of the study is to evaluate the effect of a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) on the quality of life of patients and their caregivers.
Detailed description
Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder, which is characterized by a variable combination of parkinsonism, cerebellar dysfunction, autonomic failure, and additional signs. No effective treatment is available. MSA patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA as other neurodegenerative diseases cause profound declines in functioning ; thus, many patients require caregivers for assistance with daily living. Caregiving can also be extremely stressful, and many caregivers experience declines in mental health. All of these repercussions contribute to the deterioration of the caregiver's quality of life and they can have an impact on the patient, in particular, on the patient's survival. Improving quality of life is a major element and identifying effective targeted interventions would bring immediate and direct benefit to patients and their families. In this context, it seems that a multimodal intervention as proposed by the NYU Caregiver Counseling and Support Intervention (NYUCI) developed by Mittelman could contribute to improve disease management and better coping with daily living difficulties. The NYUCI strategy combines sessions of individual and family counseling, support group participation, and additional on-call telephone consultations in a flexible counseling approach that is tailored to each caregiving family
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal intervention at inclusion | Experimental | Behavioral: Multimodal interventionMultimodal intervention will be proposed to Multiple system atrophy patients and their caregivers. |
| Multimodal intervention at 6 month | Other | Behavioral: Multimodal interventionMultimodal intervention will be proposed to Multiple system atrophy patients and their caregivers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Multimodal interventionThe intervention consists of identifying the individual needs of each caregiver and patient and identifying sources of improvement in the management of daily life, including the optimization of social support. This optimization requires the involvement of people in the environment (family, friends, neighbours) who can provide help, support of any kind, recurrent or punctual, minimizing negative family interactions and maximizing positive contributions by each in supporting and supporting the individual. The intervention is personalized in the sense that the content of each session seeks to adapt itself to the specificities of the couple situation and its surroundings. interviews/meetings involving a psychologist social worker. | Behavioural | Multimodal intervention at 6 month, Multimodal intervention at inclusion |
Primary outcome
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Time frame: Day 0
Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Time frame: 6 month
Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Time frame: 12 month
Score of emotional and social sub-dimension of the MSA Quality of Life scale. Quality of life questionnaire to collect the level of difficulty experienced by the patient (from no problem to extreme problem) during the 4 weeks preceding the interview on activities such as: moving; walking; maintaining balance; speak; feed oneself. It also assesses the patient's feelings about his illness.
30 secondary outcomes
Center for Epidemiologic Sutdies-Depression (CESD) Score
Time frame: Day 0
Center for Epidemiologic Sutdies-Depression (CESD) Score
Time frame: 3 month
Center for Epidemiologic Sutdies-Depression (CESD) Score
Time frame: 6 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Time frame: Day 0
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Time frame: 3 month
Multiple System Atrophy Quality of Life (MSA-QoL) Score
Time frame: 6 month
State Trait Inventory Anxiety (STAI) Score
Time frame: Day 0
State Trait Inventory Anxiety (STAI) Score
Time frame: 3 month
State Trait Inventory Anxiety (STAI) Score
Time frame: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) I
Time frame: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) I
Time frame: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) I
Time frame: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) II
Time frame: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) II
Time frame: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) II
Time frame: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) III
Time frame: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) III
Time frame: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) III
Time frame: 6 month
Unified Multiple System Atrophy Rating Scale (UMSARS) IV
Time frame: Day 0
Unified Multiple System Atrophy Rating Scale (UMSARS) IV
Time frame: 3 month
Unified Multiple System Atrophy Rating Scale (UMSARS) IV
Time frame: 6 month
Montreal Cognitive Assessment (MoCA) Score
Time frame: Day 0
Montreal Cognitive Assessment (MoCA) Score
Time frame: 3 month
Montreal Cognitive Assessment (MoCA) Score
Time frame: 6 month
Zarit Scale score
Time frame: Day 0
Zarit Scale score
Time frame: 3 month
Zarit Scale score
Time frame: 6 month
Family Relations Index (FRI)
Time frame: Day 0
Family Relations Index (FRI)
Time frame: 3 month
Family Relations Index (FRI)
Time frame: 6 month
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 20 May 2026.
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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.
Alexandra FOUBERT-SAMIER principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal intervention in people with Multiple System Atrophy, run by University Hospital, Bordeaux 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?
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 20 May 2026. 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?
Multiple System Atrophy Quality of Life (MSA-QoL) Score (time frame: Day 0). The study lists 3 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 20 May 2026.