The MOTIVE-PSP Initiative (Progressive Supranuclear Palsy)

NCT04691635 | Unknown

• 1 other identifier: CEMAND-2020-02
• Study Type: observational
• Target: 165
• Locations: 1 country
• Sites: 3

Brief Summary

Progressive Supranuclear Palsy (PSP) is a rapidly progressive neurodegenerative disease characterized by falls and oculomotor disturbances. Several clinical trials are currently evaluating the efficacy of new pharmacological compounds in slowing disease progression. Yet, both early diagnosis and evaluation of disease progression remain challenging. Study aims include verifying if specific motor, cognitive, language, cerebrospinal fluid and imaging assessments represent reliable biomarkers of PSP diagnosis, phenotypization and progression over 1-year follow up. Motor evaluation will include recordings from wearable sensors. Expected results include 1) improvement of PSP diagnosis and phenotypization; 2)improvement of evaluation of disease progression in the context of clinical trial; 3)enhancement of strategies to prevent falls and fractures in such patients leading, in turn, to significant cost savings for the National Health System.

Conditions

Progressive Supranuclear Palsy

Outcome Measures

Primary Outcomes (1)

• Progressive Supranuclear Palsy rating scale

  Progression of disease as assessed with the standard clinical scale rating (scoring 0-100, higher scores indicate worse scores) Progressive Supranuclear Palsy symptoms and signs

  1-year follow up

Secondary Outcomes (4)

• Cognitive progression

  1-year follow up

• Behavioral progression

  1-year follow up

• MRI

  1-year follow up

• Gait speed

  1-year follow up

Study Arms (3)

Group 1

Patients with Progressive Supranuclear Palsy

Other: evaluation of movements with sensors

Group 2

Patients with Parkinson's disease

Other: evaluation of movements with sensors

Group 3

Healthy controls

Other: evaluation of movements with sensors

Interventions

evaluation of movements with sensors OTHER

evaluation of movements with sensors

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Progressive Supranuclera palsy. Any phenotype of the disease will be included

You may qualify if:

• Diagnosis of Progressive Supranuclear Palsy based on current available clinical criteria
• ability to walk for at least 5 steps

You may not qualify if:

• Comorbidities interfering with study assessments
• Significant MRI abnormalities as cerebrovascular diseases, tumors.

Sponsors & Collaborators

• University of Salerno: lead
• Azienda Ospedaliera di Padova: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator

Study Sites (3)

AOU Padova

Padua, Italy

NOT YET RECRUITING

AOU Pisa

Pisa, Italy

NOT YET RECRUITING

AOU San Giovanni di Dio e Ruggi d'Aragona

Salerno, 84131, Italy

RECRUITING

Related Publications (7)

• Picillo M, Abate F, Ponticorvo S, Tepedino MF, Erro R, Frosini D, Del Prete E, Cecchi P, Cosottini M, Ceravolo R, Salle GD, Salle FD, Esposito F, Pellecchia MT, Manara R, Barone P. Association of MRI Measures With Disease Severity and Progression in Progressive Supranuclear Palsy. Front Neurol. 2020 Nov 12;11:603161. doi: 10.3389/fneur.2020.603161. eCollection 2020.

  PMID: 33281738 BACKGROUND

• Picillo M, Cuoco S, Carotenuto I, Abate F, Erro R, Volpe G, Pellecchia MT, Catricala E, Cappa S, Barone P. Clinical use of SAND battery to evaluate language in patients with Progressive Supranuclear Palsy. PLoS One. 2019 Oct 11;14(10):e0223621. doi: 10.1371/journal.pone.0223621. eCollection 2019.

  PMID: 31603934 BACKGROUND

• Picillo M, Tepedino MF, Abate F, Erro R, Ponticorvo S, Tartaglione S, Volpe G, Frosini D, Cecchi P, Cosottini M, Ceravolo R, Esposito F, Pellecchia MT, Barone P, Manara R. Midbrain MRI assessments in progressive supranuclear palsy subtypes. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):98-103. doi: 10.1136/jnnp-2019-321354. Epub 2019 Sep 16.

  PMID: 31527182 BACKGROUND

• Picillo M, Cuoco S, Amboni M, Bonifacio FP, Bruschi F, Carotenuto I, De Micco R, De Rosa A, Del Prete E, Di Biasio F, Elifani F, Erro R, Fabbri M, Falla M, Franco G, Frosini D, Galantucci S, Lazzeri G, Magistrelli L, Malaguti MC, Milner AV, Minafra B, Olivola E, Pilotto A, Rascuna C, Rizzetti MC, Schirinzi T, Borroni B, Ceravolo R, Di Fonzo A, Marchese R, Mercuri NB, Modugno N, Nicoletti A, Padovani A, Santangelo G, Stefani A, Tessitore A, Volonte MA, Zangaglia R, Zappia M, Zibetti M, Barone P. Validation of the Italian version of the PSP Quality of Life questionnaire. Neurol Sci. 2019 Dec;40(12):2587-2594. doi: 10.1007/s10072-019-04010-2. Epub 2019 Jul 26.

  PMID: 31350659 BACKGROUND

• Picillo M, Cuoco S, Amboni M, Bonifacio FP, Bruno A, Bruschi F, Cappiello A, De Micco R, De Rosa A, Di Biasio F, Elifani F, Erro R, Fabbri M, Falla M, Franco G, Frosini D, Galantucci S, Lazzeri G, Magistrelli L, Malaguti MC, Milner AV, Minafra B, Olivola E, Pilotto A, Rascuna C, Rizzetti MC, Schirinzi T, Borroni B, Ceravolo R, Di Fonzo A, Lopiano L, Marchese R, Mercuri NB, Modugno N, Nicoletti A, Padovani A, Santangelo G, Stefani A, Tessitore A, Volonte MA, Zangaglia R, Zappia M, Barone P. Validation of the Italian version of carers' quality-of-life questionnaire for parkinsonism (PQoL Carer) in progressive supranuclear palsy. Neurol Sci. 2019 Oct;40(10):2163-2169. doi: 10.1007/s10072-019-03944-x. Epub 2019 Jun 12.

  PMID: 31190253 BACKGROUND

• Picillo M, Cuoco S, Tepedino MF, Cappiello A, Volpe G, Erro R, Santangelo G, Pellecchia MT, Barone P; PSP Salerno study group. Motor, cognitive and behavioral differences in MDS PSP phenotypes. J Neurol. 2019 Jul;266(7):1727-1735. doi: 10.1007/s00415-019-09324-x. Epub 2019 Apr 15.

  PMID: 30989369 BACKGROUND

• Picillo M, Erro R, Cuoco S, Tepedino MF, Manara R, Pellecchia MT, Barone P; PSP Salerno Study Group. MDS PSP criteria in real-life clinical setting: Motor and cognitive characterization of subtypes. Mov Disord. 2018 Aug;33(8):1361-1365. doi: 10.1002/mds.27408. Epub 2018 Jul 8. No abstract available.

  PMID: 29984518 BACKGROUND

MeSH Terms

Conditions

Supranuclear Palsy, Progressive

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Neurodegenerative Diseases; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Marina Picillo, MD

CONTACT

00393497725402; mpicillo@unisa.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 31, 2020
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: February 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)