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NCT Number: NCT05752656

Short- and Long-term Behavioral, Cognitive and Motor Outcomes of Frameless Deep Brain Stimulation in Patients With Parkinson's Disease: a Prospective Observational Study

The main objective of the study is to evaluate the improvement in quality of life after deep brain stimulation surgery with frameless technique by comparing the PDQ-39 scale score at baseline (before surgery) and one year after surgery.

Recruiting

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • diagnosis of idiopathic Parkinson's disease according to Movement Disorder Society (MDS) criteria;
  • patients who are candidates for deep brain stimulation intervention, according to the international criteria of the "Core assessment program for surgical interventional therapies in Parkinson's disease" (CAPSIT-PD).

Exclusion criteria

  • patients unable to give informed consent.

Treatment and study plan

Clinical examinations

Other

Clinical examinations and administration of clinical scales

Primary outcomes

  1. Improvement of quality of life

    Time frame: One year

    Evaluation of the PDQ-39 scale score at baseline (before surgery) and one year after surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Bove, MD

CONTACT

[email protected]

+390630156433

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2034
First posted
Mar 3, 2023
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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