Parkinson DiseaseBRABOAXPDNCT07187843
Study of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Brain-first and Body-first PD
An observational study of Parkinson Disease and Parkinsonian Disorders, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease, Parkinsonian Disorders, Brain Disease
- What is being tested?
- Clinical assessments and Phenotypic classification
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 4 Sep 2024to May 2031
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia. Eligible participants will be adults diagnosed with PD according to international clinical criteria, in the initial stages of the disease, and not yet affected by major motor or cognitive disability. Patients will be characterized from both a clinical and instrumental perspective, including motor and non-motor symptoms, genetic background, and biomarkers of neurodegeneration and neuroinflammation.
Who may be able to join
- Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy [123I-MIBG].
- Free and informed consent expressed by the participant.
- At least 18 years of age.
Who cannot join
- Inability to express free and informed consent.
- Patient with a doubtful diagnosis.
- Participant under 18 years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Francesco Cavallieri, MD contact
Stefania Croci, BSc contact
Italy1 site, 1 recruiting
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
Francesco Cavallieri, MD, francesco.cavallieri@ausl.re.it
About this study
Official title: Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes
This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed "Brain-First" and "Body-First" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability.
Findings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.
Read the detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, affecting up to 1% of individuals over the age of 60. While treatment remains symptomatic and no disease-modifying therapies are currently available, increasing research efforts are focusing on precision medicine approaches and the identification of disease subtypes that may guide prognosis and therapy.
Historically, PD patients have been classified according to motor (tremor-dominant, akinetic-rigid, axial) and non-motor features (sleep disturbances, autonomic dysfunction, mood disorders, fatigue, pain, weight loss, cognitive impairment). Genetic classifications have also been introduced, with approximately 10-15% of patients carrying mutations such as GBA or LRRK2, which are associated with earlier onset and potentially more aggressive disease.
In the early 2000s, Braak and colleagues proposed a neuropathological staging system in which α-synuclein pathology progresses in a stereotypical pattern from peripheral to central structures. More recent clinical and pathological evidence, however, has challenged this model and led to the proposal of two distinct subtypes: Brain-First and Body-First. In Brain-First PD, pathology begins in the central nervous system and spreads to the autonomic system; in Body-First PD, pathology originates in peripheral structures such as the enteric nervous system, propagating rostrally to involve the brain. REM sleep behavior disorder (RBD) has emerged as a clinical marker of the Body-First subtype.
This study will systematically characterize patients with early-stage PD, combining detailed clinical evaluation with instrumental assessments including neuroimaging and blood-based biomarkers. In particular, the project will investigate whether Brain-First and Body-First phenotypes differ in terms of:
- Clinical progression (with focus on axial and cognitive symptoms).
- Neurodegeneration biomarkers, including neurofilament light chain.
- Neuroinflammation markers, such as immune responses to α-synuclein, interferon-gamma, and interleukin-5.
The overarching goal is to identify biological and clinical markers that distinguish PD subtypes, improve early stratification, and support the development of targeted, disease-modifying therapies.
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Brain Disease, Basal Ganglia Diseases, Synucleinopathies
- Being tested
- Clinical assessments, Phenotypic classification
- Keywords
- Neurodegenerative Diseases, Nervous System Diseases, Movement Disorders, biomarker, neuroinflammation, brain-first, body-first, axial symptoms
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Brain Diseases, Basal Ganglia Diseases, Synucleinopathies, Neurodegenerative Diseases, Nervous System Diseases, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentsOther
standardized neurological examination, motor and non-motor symptom scales, cognitive testing, and autonomic symptom questionnaires.
Phenotypic classificationOther
patients will be stratified into Brain-First and Body-First phenotypes based on the presence of RBD and instrumental findings.
| Study group | Role | What they receive |
|---|---|---|
| Early Parkinson's Disease (Brain-First phenotype) | Patients with early-stage Parkinson's disease without REM sleep behavior disorder (RBD), consistent with a Brain-First phenotype. These patients typically show early central dopaminergic deficits followed by peripheral involvement. Receives: Other: Clinical assessments; Other: Phenotypic classification | |
| Early Parkinson's Disease (Body-First phenotype) | Patients with early-stage Parkinson's disease with REM sleep behavior disorder (RBD) before or at motor onset, consistent with a Body-First phenotype. These patients are expected to show early peripheral involvement (e.g., cardiac MIBG denervation) preceding central dopaminergic loss. Receives: Other: Clinical assessments; Other: Phenotypic classification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the progression of axial symptoms
Differences in quantitative parameters of gait (phase duration, root mean square of the acceleration of the trunk in x, y, z axes) assessed through the instrumented Timed Up and Go test (phases considered: overall iTUG, sit-to-stand, sitting, first turn, second turn, walking forward, return gait) between the brain-first and body-first groups at diagnosis and at subsequent annual follow-up visits (5-year follow-up) in OFF-medication and ON-Medication (both in single and dual task) conditions.
Measured: baseline, 12, 24, 36,48, 60 months
Risk of falling in the two subgroups, brain-first and body-first
Assessment of possible differences in scores obtained on the Walking Handicap Scale (WHS) at baseline and at subsequent annual follow-up visits (5-year follow-up). The Walking Handicap Scale (WHS) measures walking ability and community mobility across six levels, from limited physiological walking to unrestricted social ambulation. Possible scores range from 1 (most limited walking ability) to 6 (fully independent walking in social environments); higher scores indicate better walking function.
Measured: baseline, 12, 24, 36,48, 60 months
Risk of falling in the two subgroups, brain-first and body-first
Assessment of possible differences in scores obtained on the Hendrich II Fall Risk Model (HIIFRM) at baseline and at subsequent annual follow-up visits (5-year follow-up). The Hendrich II Fall Risk Model (HIIFRM) assesses fall risk using clinical variables including confusion/disorientation/impulsivity, symptomatic depression, altered elimination, dizziness, gender, use of antiepileptics or benzodiazepines, and performance on the "Get-Up-and-Go" test. Possible total scores range from 0 (lowest fall risk) upwards (commonly up to about 16 depending on version); higher scores indicate greater fall risk.
Measured: baseline, 12, 24, 36,48, 60 months
Assessment of the progression of axial symptoms
Differences in quantitative parameters of balance (center of pressure mean position referred to the mid-point of the heels, area of the 95% confidence ellipse, sway mean velocities and root mean square displacements in the antero-posterior and medio-lateral directions) assessed through a static posturography test (with eyes open) between the brain-first and body-first groups at diagnosis and at subsequent annual follow-up visits (5-year follow-up) in OFF-medication and ON-Medication (both in single and dual task) conditions.
Measured: baseline, 12, 24, 36,48, 60 months
Secondary outcomes (4)
Assessment of disease progression
Assessment of the differences in the MDS-UPDRS total scores (part I, II, III, IV) and subscores (tremor, bradykinesia, rigidity, postural instability and gait difficulty, gait, dyskinesia and fluctuations subscores) in the study population at baseline and at subsequent annual follow-up visits (5-year follow-up).
Measured: baseline, 12, 24, 36,48, 60 months
Assessment of the progression of neurodegeneration and inflammatory biomarkers (neurofilaments, interferon-γ, cell-mediated anti-α-synuclein responses).
Assessment of the differences in neurodegeneration and inflammatory biomarkers (neurofilaments, interferon-γ, cell-mediated anti-α-synuclein responses) in a subset of 50 patients in the study population. Analysis of differences in neurofilament levels and cell-mediated responses at baseline and at subsequent annual follow-up visits (5-year follow-up).
Measured: baseline, 12, 24, 36,48, 60 months
Brain MRI: analysis of differences in qualitative and quantitative parameters extrapolated at diagnosis.
Assessment of quantitative differences in the degree of cortical and subcortical atrophy (volumetric automated segmentation of cerebral regions with the Quibim Precision software® quantified as % of intracranial volume) in the study population assessed through volumetric 1.5 Tesla brain MRI at baseline.
Measured: 24 months
Baseline Assessment of Nigrostriatal and Myocardial Denervation.
Semiquantitative assessment (heart to mediastinum ratio [H/M]) of differences in myocardial denervation in the study population through cardiac 123I-MIBG scintigraphy (early and delayed imaging)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start4 Sep 2024
- Primary completion30 Oct 2025
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187843
- Sponsor's protocol ID
- 350/2024/OSS/AUSLRE
- Acronym
- BRABOAXPD
- Status last verified
- Aug 2025
- First submitted
- 3 Sep 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Piancino MG, Farina D, Talpone F, Merlo A, Bracco P. Muscular activation during reverse and non-reverse chewing cycles in unilateral posterior crossbite. Eur J Oral Sci. 2009 Apr;117(2):122-8. doi: 10.1111/j.1600-0722.2008.00601.x.
PubMed 19320720Cavallieri F, Gessani A, Merlo A, Campanini I, Budriesi C, Fioravanti V, Di Rauso G, Feletti A, Damiano B, Scaltriti S, Guagnano N, Bardi E, Corni MG, Antonelli F, Cavalleri F, Molinari MA, Contardi S, Menozzi E, Puzzolante A, Vannozzi G, Bergamini E, Pavesi G, Fraix V, Meoni S, Fraternali A, Versari A, Lusuardi M, Biagini G, Pinto S, Moro E, Valzania F. Interplay between speech and gait variables in Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation: A long-term instrumental assessment. Eur J Neurol. 2023 Jul;30(7):1963-1972. doi: 10.1111/ene.15803. Epub 2023 Apr 10.
PubMed 36971736Merlo A, Zemp D, Zanda E, Rocchi S, Meroni F, Tettamanti M, Recchia A, Lucca U, Quadri P. Postural stability and history of falls in cognitively able older adults: the Canton Ticino study. Gait Posture. 2012 Sep;36(4):662-6. doi: 10.1016/j.gaitpost.2012.06.016. Epub 2012 Jul 24.
PubMed 22832469Horsager J, Knudsen K, Sommerauer M. Clinical and imaging evidence of brain-first and body-first Parkinson's disease. Neurobiol Dis. 2022 Mar;164:105626. doi: 10.1016/j.nbd.2022.105626. Epub 2022 Jan 11.
PubMed 35031485Horsager J, Andersen KB, Knudsen K, Skjaerbaek C, Fedorova TD, Okkels N, Schaeffer E, Bonkat SK, Geday J, Otto M, Sommerauer M, Danielsen EH, Bech E, Kraft J, Munk OL, Hansen SD, Pavese N, Goder R, Brooks DJ, Berg D, Borghammer P. Brain-first versus body-first Parkinson's disease: a multimodal imaging case-control study. Brain. 2020 Oct 1;143(10):3077-3088. doi: 10.1093/brain/awaa238.
PubMed 32830221Bohnen NI, Postuma RB. Body-first versus brain-first biological subtyping of Parkinson's disease. Brain. 2020 Oct 1;143(10):2871-2873. doi: 10.1093/brain/awaa293.
PubMed 33103732
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Progression of Axial and Cognitive Symptoms and Biomarkers of Neurodegeneration in Patients With Parkinson's Disease Divided Into Brain-first and Body-first Phenotypes
- ClinicalTrials.gov ID
- NCT07187843
- Acronym / sponsor ID
- BRABOAXPD / 350/2024/OSS/AUSLRE
- Conditions
- Parkinson Disease, Parkinsonian Disorders, Brain Disease, Basal Ganglia Diseases, Synucleinopathies
- Keywords
- Neurodegenerative Diseases, Nervous System Diseases, Movement Disorders, biomarker, neuroinflammation, brain-first, body-first, axial symptoms
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 4 Sep 2024 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- May 2031 (estimated)
- First posted
- 23 Sep 2025 (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.
This observational study aims to systematically characterize a cohort of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia, Italy. PD is the second most common neurodegenerative disorder, affecting about 1% of individuals over 60 years of age. The project will explore clinical and biological differences between the recently proposed "Brain-First" and "Body-First" phenotypes of PD. Patients will undergo detailed clinical evaluation, neuroimaging, and biomarker assessments (including neurodegeneration and neuroinflammation markers). Particular attention will be given to the progression of axial and cognitive symptoms, which represent major contributors to disability.
Findings from this study are expected to improve early patient stratification, clarify disease mechanisms, and support the development of precision medicine strategies and future disease-modifying therapies.
Detailed description
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, affecting up to 1% of individuals over the age of 60. While treatment remains symptomatic and no disease-modifying therapies are currently available, increasing research efforts are focusing on precision medicine approaches and the identification of disease subtypes that may guide prognosis and therapy.
Historically, PD patients have been classified according to motor (tremor-dominant, akinetic-rigid, axial) and non-motor features (sleep disturbances, autonomic dysfunction, mood disorders, fatigue, pain, weight loss, cognitive impairment). Genetic classifications have also been introduced, with approximately 10-15% of patients carrying mutations such as GBA or LRRK2, which are associated with earlier onset and potentially more aggressive disease.
In the early 2000s, Braak and colleagues proposed a neuropathological staging system in which α-synuclein pathology progresses in a stereotypical pattern from peripheral to central structures. More recent clinical and pathological evidence, however, has challenged this model and led to the proposal of two distinct subtypes: Brain-First and Body-First. In Brain-First PD, pathology begins in the central nervous system and spreads to the autonomic system; in Body-First PD, pathology originates in peripheral structures such as the enteric nervous system, propagating rostrally to involve the brain. REM sleep behavior disorder (RBD) has emerged as a clinical marker of the Body-First subtype.
This study will systematically characterize patients with early-stage PD, combining detailed clinical evaluation with instrumental assessments including neuroimaging and blood-based biomarkers. In particular, the project will investigate whether Brain-First and Body-First phenotypes differ in terms of:
- Clinical progression (with focus on axial and cognitive symptoms).
- Neurodegeneration biomarkers, including neurofilament light chain.
- Neuroinflammation markers, such as immune responses to α-synuclein, interferon-gamma, and interleukin-5.
The overarching goal is to identify biological and clinical markers that distinguish PD subtypes, improve early stratification, and support the development of targeted, disease-modifying therapies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Parkinson's Disease (Brain-First phenotype) | – | Other: Clinical assessments, Other: Phenotypic classificationPatients with early-stage Parkinson's disease without REM sleep behavior disorder (RBD), consistent with a Brain-First phenotype. These patients typically show early central dopaminergic deficits followed by peripheral involvement. |
| Early Parkinson's Disease (Body-First phenotype) | – | Other: Clinical assessments, Other: Phenotypic classificationPatients with early-stage Parkinson's disease with REM sleep behavior disorder (RBD) before or at motor onset, consistent with a Body-First phenotype. These patients are expected to show early peripheral involvement (e.g., cardiac MIBG denervation) preceding central dopaminergic loss. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients with early-stage Parkinson's disease (PD) attending the Movement Disorders Center of AUSL-IRCCS Reggio Emilia. Eligible participants will be adults diagnosed with PD according to international clinical criteria, in the initial stages of the disease, and not yet affected by major motor or cognitive disability. Patients will be characterized from both a clinical and instrumental perspective, including motor and non-motor symptoms, genetic background, and biomarkers of neurodegeneration and neuroinflammation.
Key inclusion criteria (3 listed)
- Patients diagnosed with PD according to the MDS Clinical Diagnostic Criteria for Parkinson's Disease divided into brain-first and body-first phenotypes, based on the presence or absence of a REM sleep behavior disorder diagnosed using ambulatory polysomnography methods according to the criteria of the International Classification of Sleep Disorders (ICSD-3) criteria and on data from SPECT with DATSCAN and myocardial innervation scintigraphy [123I-MIBG].
- Free and informed consent expressed by the participant.
- At least 18 years of age.
Key exclusion criteria (3 listed)
- Inability to express free and informed consent.
- Patient with a doubtful diagnosis.
- Participant under 18 years of age.
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 |
|---|---|---|
| Clinical assessmentsstandardized neurological examination, motor and non-motor symptom scales, cognitive testing, and autonomic symptom questionnaires. | Other | Early Parkinson's Disease (Body-First phenotype), Early Parkinson's Disease (Brain-First phenotype) |
| Phenotypic classificationpatients will be stratified into Brain-First and Body-First phenotypes based on the presence of RBD and instrumental findings. | Other | Early Parkinson's Disease (Body-First phenotype), Early Parkinson's Disease (Brain-First phenotype) |
Primary outcome
Assessment of the progression of axial symptoms
Time frame: baseline, 12, 24, 36,48, 60 months
Differences in quantitative parameters of gait (phase duration, root mean square of the acceleration of the trunk in x, y, z axes) assessed through the instrumented Timed Up and Go test (phases considered: overall iTUG, sit-to-stand, sitting, first turn, second turn, walking forward, return gait) between the brain-first and body-first groups at diagnosis and at subsequent annual follow-up visits (5-year follow-up) in OFF-medication and ON-Medication (both in single and dual task) conditions.
Risk of falling in the two subgroups, brain-first and body-first
Time frame: baseline, 12, 24, 36,48, 60 months
Assessment of possible differences in scores obtained on the Walking Handicap Scale (WHS) at baseline and at subsequent annual follow-up visits (5-year follow-up). The Walking Handicap Scale (WHS) measures walking ability and community mobility across six levels, from limited physiological walking to unrestricted social ambulation. Possible scores range from 1 (most limited walking ability) to 6 (fully independent walking in social environments); higher scores indicate better walking function.
Risk of falling in the two subgroups, brain-first and body-first
Time frame: baseline, 12, 24, 36,48, 60 months
Assessment of possible differences in scores obtained on the Hendrich II Fall Risk Model (HIIFRM) at baseline and at subsequent annual follow-up visits (5-year follow-up). The Hendrich II Fall Risk Model (HIIFRM) assesses fall risk using clinical variables including confusion/disorientation/impulsivity, symptomatic depression, altered elimination, dizziness, gender, use of antiepileptics or benzodiazepines, and performance on the "Get-Up-and-Go" test. Possible total scores range from 0 (lowest fall risk) upwards (commonly up to about 16 depending on version); higher scores indicate greater fall risk.
Assessment of the progression of axial symptoms
Time frame: baseline, 12, 24, 36,48, 60 months
Differences in quantitative parameters of balance (center of pressure mean position referred to the mid-point of the heels, area of the 95% confidence ellipse, sway mean velocities and root mean square displacements in the antero-posterior and medio-lateral directions) assessed through a static posturography test (with eyes open) between the brain-first and body-first groups at diagnosis and at subsequent annual follow-up visits (5-year follow-up) in OFF-medication and ON-Medication (both in single and dual task) conditions.
4 secondary outcomes
Assessment of disease progression
Time frame: baseline, 12, 24, 36,48, 60 months
Assessment of the progression of neurodegeneration and inflammatory biomarkers (neurofilaments, interferon-γ, cell-mediated anti-α-synuclein responses).
Time frame: baseline, 12, 24, 36,48, 60 months
Brain MRI: analysis of differences in qualitative and quantitative parameters extrapolated at diagnosis.
Time frame: 24 months
Baseline Assessment of Nigrostriatal and Myocardial Denervation.
Time frame: 24 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 Apr 2026.
- Background: PubMed 19320720Piancino MG, Farina D, Talpone F, Merlo A, Bracco P. Muscular activation during reverse and non-reverse chewing cycles in unilateral posterior crossbite. Eur J Oral Sci. 2009 Apr;117(2):122-8. doi: 10.1111/j.1600-0722.2008.00601.x.
- Background: PubMed 36971736Cavallieri F, Gessani A, Merlo A, Campanini I, Budriesi C, Fioravanti V, Di Rauso G, Feletti A, Damiano B, Scaltriti S, Guagnano N, Bardi E, Corni MG, Antonelli F, Cavalleri F, Molinari MA, Contardi S, Menozzi E, Puzzolante A, Vannozzi G, Bergamini E, Pavesi G, Fraix V, Meoni S, Fraternali A, Versari A, Lusuardi M, Biagini G, Pinto S, Moro E, Valzania F. Interplay between speech and gait variables in Parkinson's disease patients treated with subthalamic nucleus deep brain stimulation: A long-term instrumental assessment. Eur J Neurol. 2023 Jul;30(7):1963-1972. doi: 10.1111/ene.15803. Epub 2023 Apr 10.
- Background: PubMed 22832469Merlo A, Zemp D, Zanda E, Rocchi S, Meroni F, Tettamanti M, Recchia A, Lucca U, Quadri P. Postural stability and history of falls in cognitively able older adults: the Canton Ticino study. Gait Posture. 2012 Sep;36(4):662-6. doi: 10.1016/j.gaitpost.2012.06.016. Epub 2012 Jul 24.
- Background: PubMed 35031485Horsager J, Knudsen K, Sommerauer M. Clinical and imaging evidence of brain-first and body-first Parkinson's disease. Neurobiol Dis. 2022 Mar;164:105626. doi: 10.1016/j.nbd.2022.105626. Epub 2022 Jan 11.
- Background: PubMed 32830221Horsager J, Andersen KB, Knudsen K, Skjaerbaek C, Fedorova TD, Okkels N, Schaeffer E, Bonkat SK, Geday J, Otto M, Sommerauer M, Danielsen EH, Bech E, Kraft J, Munk OL, Hansen SD, Pavese N, Goder R, Brooks DJ, Berg D, Borghammer P. Brain-first versus body-first Parkinson's disease: a multimodal imaging case-control study. Brain. 2020 Oct 1;143(10):3077-3088. doi: 10.1093/brain/awaa238.
- Background: PubMed 33103732Bohnen NI, Postuma RB. Body-first versus brain-first biological subtyping of Parkinson's disease. Brain. 2020 Oct 1;143(10):2871-2873. doi: 10.1093/brain/awaa293.
- Individual participant dataSharing planned: Undecided
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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.
Francesco Cavallieri, MD contact
Stefania Croci, BSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinsonian Disorders, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
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 3 inclusion and 3 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 Apr 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 Italy. 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 Francesco Cavallieri, MD (francesco.cavallieri@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the progression of axial symptoms (time frame: baseline, 12, 24, 36,48, 60 months). The study lists 4 primary outcomes in all. 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 NCT07187843, which also lists 6 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 23 Apr 2026.