Multiple System AtrophyMeDeMSANCT06072105

Medical Decision Making in Multiple System Atrophy

A study testing Telemedicine visits and Multidisciplinary, personalized symptomatic treatment in people with Multiple System Atrophy, run by Medical University Innsbruck at 1 site in Austria.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

The goal of this clinical study is to evaluate the effects of a personalized symptomatic treatment plan integrated with monthly telemedicine and mobile palliative care interventions on a population of individuals diagnosed with Multiple System Atrophy (MSA) and their informal caregivers. Read more about this study

Who is it for?: Ages 30 years and older
Conditions the study is for: Multiple System Atrophy
What is being tested?: Telemedicine visits and Multidisciplinary, personalized symptomatic treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 92 participants
Where: 1 siteAustria
Study dates: 1 Oct 2023to Sep 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 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

For individuals with MSA:
Age ≥30 years at the time of consent;
Diagnosed with clinically probable or clinically established MSA according to the current MDS MSA criteria (1);
Life-expectancy of at least 24 months as assessed by the investigator at the time of consent;
Understands and agrees to comply with the study procedures and provides written informed consent (Note: a legal representative may NOT provide consent on behalf of the subject);
Signed and dated informed consent document;

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Fluency in German;
If not able to walk or stand without assistance/support at the time of consent, the participant lives in Tyrol or in another Austrian Region with available mobile palliative care.
For informal caregivers:
Informal caregiver (i.e. person not receiving payment for his/her caregiving) of an individual with MSA recruited in the present study;
Life-expectancy of at least 24 months as assessed by the investigator at the time of consent;
Age≥ 18 years at the time of consent;
Understands and agrees to provide information as outlined in the study protocol and to engage in semi-structured online interviews;
Provides signed and dated written informed consent;
Full legal capacity;
Fluency in German.

Who cannot join

For individuals with MSA
Participation in an interventional clinical study at screening and throughout the study that would interfere with the MeDeMSA Care personalized treatment plan or would not permit telemedicine and mobile palliative care strategies;
Charlson comorbidity index >4 at the time of consent;
Other major underlying medical conditions that may confound interpretation of study results as assessed by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Alessandra Fanciulli, MD PhD contact

+4351250483238

alessandra.fanciulli@i-med.ac.at

Austria1 site, 1 recruiting

Innsbruck Medical University
Innsbruck, Austria, 6020
Alessandra Fanciulli, MD PhD, +4351250483238, alessandra.fanciulli@i-med.ac.at
Recruiting

Other trials in Austria

About this study

Official title: Medical Decision Making in Multiple System Atrophy: Developing Personalized Best Medical Care with Integrated Telemedicine and Mobile Palliative Care for Individuals with Multiple System Atrophy

After a baseline visit, all 46 patients will receive a personalized therapeutic plan (including medical treatment, physiotherapy, logotherapy and occupational therapy excercises and psychological support) and contact with social workers and a palliative care team. They willl then be re-evaluated at 6-,12-, 18- month visits. Semi-structured online interviews at baseline and 12 month visit will collect patients' individual healthcare preferences, which will be taken into account in the preparation of the individual therapeutic plan. Twenty-three patients will be randomized to receive monthly telemedicine visits. Assessment of patients´satisfaction with the therapeutic plan, with the palliative interventions (when they occurred) and the telemedicine visits will be carried over the 18 month period.

Forty-six informal caregivers will be invited to participate with semi-structured online interviews and assessment of their QoL and caregivers' burden.

Read the detailed description

This is a monocentric, 18-months, randomized, rater-blinded study to evaluate the influence of a multidisciplinary, personalized symptomatic treatment plan with integrated mobile palliative care and telemedicine on the baseline to 18-months change in the QoL of individuals with MSA compared to a sex-, age- and disease-duration matched historical European MSA cohort, whose data is stored at the Medical University of Innsbruck.

We plan to recruit 46 individuals with MSA fulfilling all the inclusionand none of the exclusion criteria. Upon collection of written informed consent, the recruited individuals will be instructed to complete a falls protocol referred to the month preceding the baseline visit, as well as a blood pressure (BP), bladder diary for up to 72 hours prior to the baseline visit. They will subsequently undergo a baseline examination including a comprehensive clinical, psychological and neuro-rehabilitation assessment, as well as an online semi-structured interview aimed at pinpointing the individual therapeutic needs and healthcare preferences. In case additional examinations are needed, these will be carried out on the same day of the baseline visit or, if not possible for individual or appointment reasons, at the earliest possible time point within the given timeframe as outlined in the visit schedule. Upon completion of the baseline visit and examinations, the individualized therapeutic plan, including mobile palliative care offer (for wheelchair-bound individuals) and guidance for self-practiced physio-, speech and occupational exercises will be prepared based on a standardized operational protocol drafted by the study team on the basis of published consensus recommendations, scientific evidence and principles of good clinical practice and adapted to the individual healthcare preferences and therapeutic needs of the recruited individuals.

Six, 12 and 18 months after the baseline visit, in-person visits will be scheduled, including a comprehensive clinical, psychological and neuro-rehabilitation re-assessment of the individual therapeutic needs. Therapeutic adaptations will be made following the standardized operational protocol and adapted to the individual healthcare preferences. In the event that the enrolled subjects are for legitimate reasons unable to travel to hospital, they will be offered the opportunity to complete the scheduled on-site assessments of month 6, 12, and 18 using the CHES online platform.

At month 12 the online semi-structured interview will be repeated to assess for eventual changes in the individual healthcare preferences due to the disease progression.

At month 1, 7 and 13, follow-up phone calls will be scheduled to verify the compliance with the individualized treatment plan and identify barriers to its application.

At month 1, 7, 13 and 18, the study participants will be invited to complete online satisfaction surveys with the overall individualized treatment plan.

Twenty-three patients will be block-wise randomized to receive additional monthly and on-demand neurological, psychological, physio-, occupational and speech therapy (based on individual needs) telemedicine visits through the CHES teleconsultation facility of the Tirol Kliniken.

Upon completion of the telemedicine visit (or on-demand mobile palliative interventions, for wheelchair-bound individuals, whenever needed and wished), brief satisfaction surveys will be sent to the study participants through the CHES platform.

Informal caregivers of the individuals with MSA recruited in the present study will be invited to participate upon written informed consent in an 18 months observational study, with baseline and 12 months semi-structured online interviews and baseline, 6-, 12- and 18 months assessment of their QoL and caregivers' burden.

Conditions: Multiple System Atrophy
Being tested: Telemedicine visits, Multidisciplinary, personalized symptomatic treatment
Keywords: MSA, Movement disorders, Autonomic dysfunctions, Telemedicine, Palliative care, Caregivers burden
Medical subject headings: Multiple System Atrophy, Movement Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Telemedicine visitsOther
Monthly telemedicine neurological, psychological and neurorehabilitation (physio-, occupational and speech therapy) consultations
Multidisciplinary, personalized symptomatic treatmentOther
Multidisciplinary, personalized symptomatic treatment plus mobile palliative care interventions (if wished and needed)

Study groups in NCT06072105
Study group	Role	What they receive
Group 1	Active comparator	Personalized best medical care. Receives: Other: Multidisciplinary, personalized symptomatic treatment
Group 2	Experimental	Personalized best medical care PLUS telemedicine Receives: Other: Telemedicine visits; Other: Multidisciplinary, personalized symptomatic treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the EQ-5D-5L score
European Quality of life - 5 Dimensions - 5 Levels. This is a 5 dimensions assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression that provides a single summary index value for health status. It also includes the EQ-VAS, a self-rating of overall health on a visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A summary index with a maximum score of 1 can be derived from the five dimensions of EQ-5D by conversion with a table of scores. The maximum score of 1 indicates the best health state, in contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: Baseline to 18-months

Secondary outcomes (12)

Changes in the MSA-QoL score and subscores
The Multiple System Atrophy - Quality of Life,is a questionnaire composed of 40 items investigating several MSA-specific motor and non-motor symptoms, as well as their perceived impact on daily life and a numeric rating scale to assess the QoL of individuals diagnosed with MSA. Scores on each of the subscales of the MSA are derived by summing the respective items and transforming to a range of 0-100, with higher scores on each scale indicating a higher impact of the disease on the aspect measured by each subscale.
Measured: Baseline to 6-, 12- and 18-months
Change in motor and non-motor scales
It includes total and subscores, as video-based, rater-blinded assessment of the UMSARS (Unified Multiple System Atrophy Rating Scale) motor score and Hoehn \& Yahr changes over the study period. In both the scales a higher score is related to a higher impact of the disease on the aspect measured.
Measured: Baseline to 6-, 12- and 18-months
Time to clinical milestones
The clinical milestones are falls at least once a day, feeding by nasogastric tube or gastrostomy, unintelligible speech, indwelling catheter, wheelchair dependency.
Measured: over the 18-months study period
Changes in the individual healthcare preferences assessed by means of the Autonomy Preference Index (API)
Assessment of individual preferences about the individual healthcare
Measured: Baseline to 12- months
In-person and telemedicine medical, psychological and neurorehabilitation interventional needs of individuals with MSA
Registration of the need of support required by MSA patients
Measured: over the 18-months study period
Change in the Short Assessment of Patient Satisfaction (SAPS) referred to the overall individualized treatment plan
Assessment of patients´ level of satisfaction with the individuaized treatment plan
Measured: Month 1 to 7, 13 and 18
Individual satisfaction with the single telemedicine and mobile palliative interventions
The individual satisfaction will be assessed by means of online numeric rating scales and open-ended questions
Measured: over the 18-months study period
Healthcare professionals satisfaction with the single telemedicine and mobile palliative interventions
The individual healthcare professionals satisfaction will be assessed by means of online numeric rating scales and open-ended questions
Measured: over the 18-months study period
Number of medical complications
Record of number of medical complications occurred (e.g. falls with or w/o injuries, urinary tract infections, choking, aspiration pneumonia, hospitalizations, death, others)
Measured: over the 18-months study period
Single-intervention and cumulative healthcare costs
Record of healthcare costs
Measured: over the 18-months study period
Changes in the EQ-5D-5L score of informal caregivers of individuals with MSA recruited in the present study
European Quality of life - 5 Dimensions - 5 Levels. This is a 5 dimensions assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression that provides a single summary index value for health status. It also includes the EQ-VAS, a self-rating of overall health on a visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A summary index with a maximum score of 1 can be derived from the five dimensions of EQ-5D by conversion with a table of scores. The maximum score of 1 indicates the best health state, in contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.
Measured: Baseline to 6-, 12- and 18-months
Change in the Carers quality-of-life questionnaire for parkinsonism (PQoL Carers) score and other caregiver-burden indicators in informal caregivers of individuals with MSA recruited in the present study
The Parkinsonism Carers Quality of Life, is a questionnaire composed of 26 items and is a concise instrument with adequate psychometric qualities to assess the QoL of the caregivers of people with atypical Parkinsonism. A score of 0 indicates the best level of QoL, whereas a score of 100 the worst level.
Measured: Baseline to 6-, 12- and 18-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 2023Sep 2027

First posted10 Oct 2023
Study start1 Oct 2023
Primary completionSep 2027 (estimated)
Study completionSep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (55)Papers the sponsor has linked to this study.
Other trials for Multiple System AtrophyStudies 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
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 92 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06072105
Sponsor's protocol ID: 1225/2023
Acronym: MeDeMSA
Status last verified: Feb 2025
First submitted: 2 Oct 2023
Last updated: 5 Feb 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Wenning GK, Stankovic I, Vignatelli L, Fanciulli A, Calandra-Buonaura G, Seppi K, Palma JA, Meissner WG, Krismer F, Berg D, Cortelli P, Freeman R, Halliday G, Hoglinger G, Lang A, Ling H, Litvan I, Low P, Miki Y, Panicker J, Pellecchia MT, Quinn N, Sakakibara R, Stamelou M, Tolosa E, Tsuji S, Warner T, Poewe W, Kaufmann H. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy. Mov Disord. 2022 Jun;37(6):1131-1148. doi: 10.1002/mds.29005. Epub 2022 Apr 21.
PubMed 35445419
Wenning GK, Krismer F. Multiple system atrophy. Handb Clin Neurol. 2013;117:229-41. doi: 10.1016/B978-0-444-53491-0.00019-5.
PubMed 24095129
Kwakkenbos L, Fransen J, Vonk MC, Becker ES, Jeurissen M, van den Hoogen FH, van den Ende CH. A comparison of the measurement properties and estimation of minimal important differences of the EQ-5D and SF-6D utility measures in patients with systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):50-6. Epub 2013 Jul 22.
PubMed 23910610
Fanciulli A, Wenning GK. Multiple-system atrophy. N Engl J Med. 2015 Jan 15;372(3):249-63. doi: 10.1056/NEJMra1311488. No abstract available.
PubMed 25587949
Cortelli P, Calandra-Buonaura G, Benarroch EE, Giannini G, Iranzo A, Low PA, Martinelli P, Provini F, Quinn N, Tolosa E, Wenning GK, Abbruzzese G, Bower P, Alfonsi E, Ghorayeb I, Ozawa T, Pacchetti C, Pozzi NG, Vicini C, Antonini A, Bhatia KP, Bonavita J, Kaufmann H, Pellecchia MT, Pizzorni N, Schindler A, Tison F, Vignatelli L, Meissner WG. Stridor in multiple system atrophy: Consensus statement on diagnosis, prognosis, and treatment. Neurology. 2019 Oct 1;93(14):630-639. doi: 10.1212/WNL.0000000000008208.
PubMed 31570638
Calandra-Buonaura G, Alfonsi E, Vignatelli L, Benarroch EE, Giannini G, Iranzo A, Low PA, Martinelli P, Provini F, Quinn N, Tolosa E, Wenning GK, Abbruzzese G, Bower P, Antonini A, Bhatia KP, Bonavita J, Pellecchia MT, Pizzorni N, Tison F, Ghorayeb I, Meissner WG, Ozawa T, Pacchetti C, Pozzi NG, Vicini C, Schindler A, Cortelli P, Kaufmann H. Dysphagia in multiple system atrophy consensus statement on diagnosis, prognosis and treatment. Parkinsonism Relat Disord. 2021 May;86:124-132. doi: 10.1016/j.parkreldis.2021.03.027. Epub 2021 Mar 30.
PubMed 33839029
Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.
PubMed 29562304
Gibbons CH, Schmidt P, Biaggioni I, Frazier-Mills C, Freeman R, Isaacson S, Karabin B, Kuritzky L, Lew M, Low P, Mehdirad A, Raj SR, Vernino S, Kaufmann H. The recommendations of a consensus panel for the screening, diagnosis, and treatment of neurogenic orthostatic hypotension and associated supine hypertension. J Neurol. 2017 Aug;264(8):1567-1582. doi: 10.1007/s00415-016-8375-x. Epub 2017 Jan 3.
PubMed 28050656
Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, Hamid R, Karsenty G, Kessler TM, Schneider M, 't Hoen L, Blok B. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016 Feb;69(2):324-33. doi: 10.1016/j.eururo.2015.07.071. Epub 2015 Aug 22.
PubMed 26304502
Jordan J, Fanciulli A, Tank J, Calandra-Buonaura G, Cheshire WP, Cortelli P, Eschlboeck S, Grassi G, Hilz MJ, Kaufmann H, Lahrmann H, Mancia G, Mayer G, Norcliffe-Kaufmann L, Pavy-Le Traon A, Raj SR, Robertson D, Rocha I, Reuter H, Struhal W, Thijs RD, Tsioufis KP, Gert van Dijk J, Wenning GK, Biaggioni I. Management of supine hypertension in patients with neurogenic orthostatic hypotension: scientific statement of the American Autonomic Society, European Federation of Autonomic Societies, and the European Society of Hypertension. J Hypertens. 2019 Aug;37(8):1541-1546. doi: 10.1097/HJH.0000000000002078.
PubMed 30882602
Randerath W, Verbraecken J, Andreas S, Arzt M, Bloch KE, Brack T, Buyse B, De Backer W, Eckert DJ, Grote L, Hagmeyer L, Hedner J, Jennum P, La Rovere MT, Miltz C, McNicholas WT, Montserrat J, Naughton M, Pepin JL, Pevernagie D, Sanner B, Testelmans D, Tonia T, Vrijsen B, Wijkstra P, Levy P. Definition, discrimination, diagnosis and treatment of central breathing disturbances during sleep. Eur Respir J. 2017 Jan 18;49(1):1600959. doi: 10.1183/13993003.00959-2016. Print 2017 Jan.
PubMed 27920092
Jasemi M, Valizadeh L, Zamanzadeh V, Keogh B. A Concept Analysis of Holistic Care by Hybrid Model. Indian J Palliat Care. 2017 Jan-Mar;23(1):71-80. doi: 10.4103/0973-1075.197960.
PubMed 28216867
Hepgul N, Wilson R, Yi D, Evans C, Bajwah S, Crosby V, Wilcock A, Lindsay F, Byrne A, Young C, Groves K, Smith C, Burman R, Chaudhuri KR, Silber E, Higginson IJ, Gao W. Immediate versus delayed short-term integrated palliative care for advanced long-term neurological conditions: the OPTCARE Neuro RCT. Southampton (UK): NIHR Journals Library; 2020 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK561537/
PubMed 32902934
van Vliet LM, Gao W, DiFrancesco D, Crosby V, Wilcock A, Byrne A, Al-Chalabi A, Chaudhuri KR, Evans C, Silber E, Young C, Malik F, Quibell R, Higginson IJ; OPTCARE Neuro. How integrated are neurology and palliative care services? Results of a multicentre mapping exercise. BMC Neurol. 2016 May 10;16:63. doi: 10.1186/s12883-016-0583-6.
PubMed 27165157
Adams JL, Myers TL, Waddell EM, Spear KL, Schneider RB. Telemedicine: A valuable tool in neurodegenerative diseases. Curr Geriatr Rep. 2020 Jun;9(2):72-81. doi: 10.1007/s13670-020-00311-z. Epub 2020 Mar 14.
PubMed 32509504

Interested in taking part?

Alessandra Fanciulli, MD PhD

+4351250483238

alessandra.fanciulli@i-med.ac.at

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Multiple System Atrophy trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medical Decision Making in Multiple System Atrophy: Developing Personalized Best Medical Care with Integrated Telemedicine and Mobile Palliative Care for Individuals with Multiple System Atrophy
ClinicalTrials.gov ID: NCT06072105
Acronym / sponsor ID: MeDeMSA / 1225/2023
Conditions: Multiple System Atrophy
Keywords: MSA, Movement disorders, Autonomic dysfunctions, Telemedicine, Palliative care, Caregivers burden
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 92 participants (estimated)
Lead sponsor: Medical University InnsbruckUniversity, hospital or other
Study start: 1 Oct 2023 (actual)
Primary completion: Sep 2027 (estimated)
Study completion: Sep 2027 (estimated)
First posted: 10 Oct 2023 (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.

Forty-six informal caregivers will be invited to participate with semi-structured online interviews and assessment of their QoL and caregivers' burden.

Detailed description

At month 12 the online semi-structured interview will be repeated to assess for eventual changes in the individual healthcare preferences due to the disease progression.

At month 1, 7 and 13, follow-up phone calls will be scheduled to verify the compliance with the individualized treatment plan and identify barriers to its application.

At month 1, 7, 13 and 18, the study participants will be invited to complete online satisfaction surveys with the overall individualized treatment plan.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Group 1	Active comparator	Other: Multidisciplinary, personalized symptomatic treatmentPersonalized best medical care.
Group 2	Experimental	Other: Telemedicine visits, Other: Multidisciplinary, personalized symptomatic treatmentPersonalized best medical care PLUS telemedicine

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Age ≥30 years at the time of consent;
Diagnosed with clinically probable or clinically established MSA according to the current MDS MSA criteria (1);
Life-expectancy of at least 24 months as assessed by the investigator at the time of consent;
Understands and agrees to comply with the study procedures and provides written informed consent (Note: a legal representative may NOT provide consent on behalf of the subject);
Signed and dated informed consent document;

Key exclusion criteria (4 listed)

For individuals with MSA
Participation in an interventional clinical study at screening and throughout the study that would interfere with the MeDeMSA Care personalized treatment plan or would not permit telemedicine and mobile palliative care strategies;
Charlson comorbidity index >4 at the time of consent;
Other major underlying medical conditions that may confound interpretation of study results as assessed by the investigator.

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
Telemedicine visitsMonthly telemedicine neurological, psychological and neurorehabilitation (physio-, occupational and speech therapy) consultations	Other	Group 2
Multidisciplinary, personalized symptomatic treatmentMultidisciplinary, personalized symptomatic treatment plus mobile palliative care interventions (if wished and needed)	Other	Group 1, Group 2

Primary outcome

Change in the EQ-5D-5L score
Time frame: Baseline to 18-months
European Quality of life - 5 Dimensions - 5 Levels. This is a 5 dimensions assessment of mobility, self-care, usual activities, pain/discomfort and anxiety/depression that provides a single summary index value for health status. It also includes the EQ-VAS, a self-rating of overall health on a visual analogue scale (VAS), ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). A summary index with a maximum score of 1 can be derived from the five dimensions of EQ-5D by conversion with a table of scores. The maximum score of 1 indicates the best health state, in contrast with the scores of individual questions, where higher scores indicate more severe or frequent problems.

12 secondary outcomes

Changes in the MSA-QoL score and subscores
Time frame: Baseline to 6-, 12- and 18-months
Change in motor and non-motor scales
Time frame: Baseline to 6-, 12- and 18-months
Time to clinical milestones
Time frame: over the 18-months study period
Changes in the individual healthcare preferences assessed by means of the Autonomy Preference Index (API)
Time frame: Baseline to 12- months
In-person and telemedicine medical, psychological and neurorehabilitation interventional needs of individuals with MSA
Time frame: over the 18-months study period
Change in the Short Assessment of Patient Satisfaction (SAPS) referred to the overall individualized treatment plan
Time frame: Month 1 to 7, 13 and 18
Individual satisfaction with the single telemedicine and mobile palliative interventions
Time frame: over the 18-months study period
Healthcare professionals satisfaction with the single telemedicine and mobile palliative interventions
Time frame: over the 18-months study period
Number of medical complications
Time frame: over the 18-months study period
Single-intervention and cumulative healthcare costs
Time frame: over the 18-months study period
Changes in the EQ-5D-5L score of informal caregivers of individuals with MSA recruited in the present study
Time frame: Baseline to 6-, 12- and 18-months
Change in the Carers quality-of-life questionnaire for parkinsonism (PQoL Carers) score and other caregiver-burden indicators in informal caregivers of individuals with MSA recruited in the present study
Time frame: Baseline to 6-, 12- and 18-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 5 Feb 2025.
Background: PubMed 35445419Wenning GK, Stankovic I, Vignatelli L, Fanciulli A, Calandra-Buonaura G, Seppi K, Palma JA, Meissner WG, Krismer F, Berg D, Cortelli P, Freeman R, Halliday G, Hoglinger G, Lang A, Ling H, Litvan I, Low P, Miki Y, Panicker J, Pellecchia MT, Quinn N, Sakakibara R, Stamelou M, Tolosa E, Tsuji S, Warner T, Poewe W, Kaufmann H. The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy. Mov Disord. 2022 Jun;37(6):1131-1148. doi: 10.1002/mds.29005. Epub 2022 Apr 21.
Background: PubMed 24095129Wenning GK, Krismer F. Multiple system atrophy. Handb Clin Neurol. 2013;117:229-41. doi: 10.1016/B978-0-444-53491-0.00019-5.
Background: PubMed 23910610Kwakkenbos L, Fransen J, Vonk MC, Becker ES, Jeurissen M, van den Hoogen FH, van den Ende CH. A comparison of the measurement properties and estimation of minimal important differences of the EQ-5D and SF-6D utility measures in patients with systemic sclerosis. Clin Exp Rheumatol. 2013 Mar-Apr;31(2 Suppl 76):50-6. Epub 2013 Jul 22.
Background: PubMed 25587949Fanciulli A, Wenning GK. Multiple-system atrophy. N Engl J Med. 2015 Jan 15;372(3):249-63. doi: 10.1056/NEJMra1311488. No abstract available.
Background: PubMed 31570638Cortelli P, Calandra-Buonaura G, Benarroch EE, Giannini G, Iranzo A, Low PA, Martinelli P, Provini F, Quinn N, Tolosa E, Wenning GK, Abbruzzese G, Bower P, Alfonsi E, Ghorayeb I, Ozawa T, Pacchetti C, Pozzi NG, Vicini C, Antonini A, Bhatia KP, Bonavita J, Kaufmann H, Pellecchia MT, Pizzorni N, Schindler A, Tison F, Vignatelli L, Meissner WG. Stridor in multiple system atrophy: Consensus statement on diagnosis, prognosis, and treatment. Neurology. 2019 Oct 1;93(14):630-639. doi: 10.1212/WNL.0000000000008208.
Background: PubMed 33839029Calandra-Buonaura G, Alfonsi E, Vignatelli L, Benarroch EE, Giannini G, Iranzo A, Low PA, Martinelli P, Provini F, Quinn N, Tolosa E, Wenning GK, Abbruzzese G, Bower P, Antonini A, Bhatia KP, Bonavita J, Pellecchia MT, Pizzorni N, Tison F, Ghorayeb I, Meissner WG, Ozawa T, Pacchetti C, Pozzi NG, Vicini C, Schindler A, Cortelli P, Kaufmann H. Dysphagia in multiple system atrophy consensus statement on diagnosis, prognosis and treatment. Parkinsonism Relat Disord. 2021 May;86:124-132. doi: 10.1016/j.parkreldis.2021.03.027. Epub 2021 Mar 30.
Background: PubMed 29562304Brignole M, Moya A, de Lange FJ, Deharo JC, Elliott PM, Fanciulli A, Fedorowski A, Furlan R, Kenny RA, Martin A, Probst V, Reed MJ, Rice CP, Sutton R, Ungar A, van Dijk JG; ESC Scientific Document Group. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. 2018 Jun 1;39(21):1883-1948. doi: 10.1093/eurheartj/ehy037. No abstract available.
Background: PubMed 28050656Gibbons CH, Schmidt P, Biaggioni I, Frazier-Mills C, Freeman R, Isaacson S, Karabin B, Kuritzky L, Lew M, Low P, Mehdirad A, Raj SR, Vernino S, Kaufmann H. The recommendations of a consensus panel for the screening, diagnosis, and treatment of neurogenic orthostatic hypotension and associated supine hypertension. J Neurol. 2017 Aug;264(8):1567-1582. doi: 10.1007/s00415-016-8375-x. Epub 2017 Jan 3.
Background: PubMed 26304502Groen J, Pannek J, Castro Diaz D, Del Popolo G, Gross T, Hamid R, Karsenty G, Kessler TM, Schneider M, 't Hoen L, Blok B. Summary of European Association of Urology (EAU) Guidelines on Neuro-Urology. Eur Urol. 2016 Feb;69(2):324-33. doi: 10.1016/j.eururo.2015.07.071. Epub 2015 Aug 22.
Background: PubMed 30882602Jordan J, Fanciulli A, Tank J, Calandra-Buonaura G, Cheshire WP, Cortelli P, Eschlboeck S, Grassi G, Hilz MJ, Kaufmann H, Lahrmann H, Mancia G, Mayer G, Norcliffe-Kaufmann L, Pavy-Le Traon A, Raj SR, Robertson D, Rocha I, Reuter H, Struhal W, Thijs RD, Tsioufis KP, Gert van Dijk J, Wenning GK, Biaggioni I. Management of supine hypertension in patients with neurogenic orthostatic hypotension: scientific statement of the American Autonomic Society, European Federation of Autonomic Societies, and the European Society of Hypertension. J Hypertens. 2019 Aug;37(8):1541-1546. doi: 10.1097/HJH.0000000000002078.
Background: PubMed 27920092Randerath W, Verbraecken J, Andreas S, Arzt M, Bloch KE, Brack T, Buyse B, De Backer W, Eckert DJ, Grote L, Hagmeyer L, Hedner J, Jennum P, La Rovere MT, Miltz C, McNicholas WT, Montserrat J, Naughton M, Pepin JL, Pevernagie D, Sanner B, Testelmans D, Tonia T, Vrijsen B, Wijkstra P, Levy P. Definition, discrimination, diagnosis and treatment of central breathing disturbances during sleep. Eur Respir J. 2017 Jan 18;49(1):1600959. doi: 10.1183/13993003.00959-2016. Print 2017 Jan.
Background: PubMed 28216867Jasemi M, Valizadeh L, Zamanzadeh V, Keogh B. A Concept Analysis of Holistic Care by Hybrid Model. Indian J Palliat Care. 2017 Jan-Mar;23(1):71-80. doi: 10.4103/0973-1075.197960.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Alessandra Fanciulli, MD PhD contact

+4351250483238

alessandra.fanciulli@i-med.ac.at

Alessandra Fanciulli, MD PhD principal investigator

Medical University Innsbruck

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine visits and Multidisciplinary, personalized symptomatic treatment in people with Multiple System Atrophy, run by Medical University Innsbruck at 1 site in Austria.

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 16 inclusion and 4 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 5 Feb 2025. 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 Austria. 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 Alessandra Fanciulli, MD PhD (+4351250483238, alessandra.fanciulli@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the EQ-5D-5L score (time frame: Baseline to 18-months). 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 NCT06072105, which also lists 55 linked publications.

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 5 Feb 2025.