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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05349539
Other study ID # NEUR_05
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date December 21, 2023

Study information

Verified date March 2023
Source Neuromed IRCCS
Contact Antonio Suppa, MD, PhD
Phone 3494940365
Email antonio.suppa@uniroma1.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 21, 2023
Est. primary completion date December 21, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - diagnosis of idiopathic Parkinson's disease according to current consensus criteria and confirmed by follow-up clinical evaluations; - ability to walk independently Exclusion Criteria: - dementia (MMSE < 24/30); - comorbidities affecting gait (e.g., rheumatological or orthopedic issues); - atypical parkinsonism.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy IRCSS Neuromed Pozzilli

Sponsors (1)

Lead Sponsor Collaborator
Neuromed IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of OFF state of therapy during daily activity hours; Time spent with poor motor control despite optimized pharmacological therapy 24 hours
Primary Number of "Wearing Off" and "ON-OFF" phenomena Number of motor complications despite optimized pharmacological therapy 24 hours
Primary Number of "freezing of gait" episodes Number of paroxysmal gait disorders despite optimized pharmacological therapy 24 hours
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