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New treatment option for Parkinson Disease
Official title A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Objective (Early) Diagnosis and Therapeutic Monitoring of Parkinson's Disease Promoting Continuity of Care
ClinicalTrials.gov ID: NCT06907589
What this study is testing
- What it's testing
- The present study aims to use the SensMode System - a system composed of wearable devices for upper and lower limb movement analysis and electronic device for data acquisition and processing - on healthy subjects, subjects with idiopathic hyposmia, patients with Parkinson's disease, and subjects with de-novo drug-naïve extrapyramidal syndrome. The purpose is to identify normative data of objective motor measures obtained with such a system, as well as to increase knowledge about the potential contribution such a solution can make to the preclinical diagnosis of Parkinson's disease and the management of patients with this disease.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Healthy people -
- Adult people, both sexes, aged 50-80 years old
- MMSE score \>= 24 absence of olfactory deficit detected on IOIT olfactory test (22). Age class 50-59 years: normal with score \ 70 years: normal with...
- absence of neurological diseases
- absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or...
You likely can't join if
- Healthy people - Exclusion criteria:
- denial of informed consent to participate in the study
- Presence of olfactory deficit detected on IOIT olfactory test. Age class 50-59 years: hyposmia with score \>=6; age class 60-69 years: hyposmia with...
- body weight greater than 120 kg
- insufficient degree of cooperation
- malignant neoplasm in progress or with negative follow-up of less than 6 years
See the full eligibility criteria
- Healthy people -
- Adult people, both sexes, aged 50-80 years old
- MMSE score \>= 24 absence of olfactory deficit detected on IOIT olfactory test (22). Age class 50-59 years: normal with score \ 70 years: normal with score \<=7
- absence of neurological diseases
- absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine
- expression of informed consent to participate in the study
- people with Parkinson's disease --
- adult people, both sexes, 50-80 years of age
- MMSE score \>= 24
- people with Parkinson's disease in the absence of motor fluctuations and dyskinesias, or people with Parkinson's disease with mild motor fluctuations throughout the day, but to be examined in the ON phase and in the...
- Hoehn and Yahr stage 1, 2, 3
- absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and/or lower limbs and/or pelvis and/or spine
- expression of informed consent to participate in the study
- Healthy people - Exclusion criteria:
- denial of informed consent to participate in the study
- Presence of olfactory deficit detected on IOIT olfactory test. Age class 50-59 years: hyposmia with score \>=6; age class 60-69 years: hyposmia with score \>=7; age class \> 70 years: hyposmia with score \>=8
- body weight greater than 120 kg
- insufficient degree of cooperation
- malignant neoplasm in progress or with negative follow-up of less than 6 years
- structured joint stiffness in the upper and/or lower extremities preventing proper execution of movements
- paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury
- mono/multi/poly sensory and/or motor neuropathy
- chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
- vertiginous syndromes in the acute phase
- neurodegenerative diseases
- fever
- venous thrombosis
- cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
- spinal or joint pain of various etiologies that may affect the performance of motor exercises
- positive history of recurrent acute cervico-brachialgia and/or lumbosciatica
- people with Parkinson's disease - Exclusion criteria:
- Denial of informed consent to participate in the study
- Hoenn and Yahr stage 4, 5
- Patient who needs to use an aid (cane or walker) while walking or cannot walk unless aided by a person
- body weight greater than 120 kg
- insufficient degree of cooperation
- malignant neoplasm in place or with negative follow-up of less than 6 years
- structured joint stiffness in the upper and/or lower extremities that prevents proper execution of movements
- paresis and/or plegia of upper and/or lower limb muscle groups from both peripheral and central nerve injury mono/multi/poly sensory and/or motor neuropathy
- chronic inflammatory diseases with joint involvement of the upper and/or lower limbs
- vertiginous syndromes in the acute phase
- neurodegenerative diseases, excluding Parkinson's disease
- fever
- venous thrombosis
- cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises
- spinal or joint pain of various etiologies that may affect the performance of motor exercises
- positive history of recurrent acute cervico-brachialgia and/or low back pain
The study team makes the final eligibility decision.
Where it's taking place
- Bagno a Ripoli, Firenze, Italy
- Florence, Italy
- Massa, Italy
- Milan, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bagno a Ripoli, Firenze, Italy; Florence, Italy; Massa, Italy; Milan, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.