Instrumental Assessment of Motor Symptoms by Means of Wearable Sensors in Patients With Parkinson's Disease

NCT05349539 | Unknown

• 1 other identifier: NEUR_05
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical management of Parkinson's disease (PD) is frequently challenged by the occurrence of motor disorders and complications, such as freezing of gait, fluctuations and the ON-OFF phenomenon, primarily manifesting at home. Therapeutic decisions are usually based on periodic neurological examinations and patients' anamnestic experience collected in an outpatient setting, thus limited by several issues, including "recall bias" and subjective, semi-quantitative and operator-dependent evaluations in non-ecological settings. In the last two decades, new wearable technologies, consisting of "wireless" sensors (e.g., inertial, electromyography), have been widely applied to quantitatively assess movements in physiological and pathological conditions, even for prolonged periods in free-living settings (i.e., long-term monitoring). The aim of this study is to evaluate motor symptoms in patients with PD, such as bradykinesia, tremor, gait disturbances and balance disorders, objectively and quantitatively through the application of wearable sensors in intra- and extra hospital settings, also during common activities of daily living, in order to obtain ecological data possibly useful in the therapeutic management of the disease.

Conditions

Parkinson Disease; Motor Disorders

Keywords

Parkinson's disease; Wearable sensors

Outcome Measures

Primary Outcomes (3)

• Time of OFF state of therapy during daily activity hours;

  Time spent with poor motor control despite optimized pharmacological therapy

  24 hours

• Number of "Wearing Off" and "ON-OFF" phenomena

  Number of motor complications despite optimized pharmacological therapy

  24 hours

• Number of "freezing of gait" episodes

  Number of paroxysmal gait disorders despite optimized pharmacological therapy

  24 hours

Study Arms (2)

Healthy Subjects

Cohort of healthy subjects as control.

Patients with Parkinson's disease

Cohort of patients with Parkinson's disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include a heterogeneous cohort of patients with Parkinson's disease, with and without typical motor complications, including fluctuations and the ON-OFF phenomenon, and with and without paroxysmal gait disorders, such as freezing of gait.

You may qualify if:

• diagnosis of idiopathic Parkinson's disease according to current consensus criteria and confirmed by follow-up clinical evaluations;
• ability to walk independently

You may not qualify if:

• dementia (MMSE \< 24/30);
• comorbidities affecting gait (e.g., rheumatological or orthopedic issues);
• atypical parkinsonism.

Sponsors & Collaborators

• Neuromed IRCCS: lead

Study Sites (1)

IRCSS Neuromed

Pozzilli, Italy

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Motor Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Central Study Contacts

Antonio Suppa, MD, PhD

CONTACT

3494940365; antonio.suppa@uniroma1.it

Study Design

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

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: April 27, 2022
• Study Start: June 1, 2022
• Primary Completion: December 21, 2022
• Study Completion: December 21, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Locations

IT (1)