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Completed

NCT Number: NCT03227250

Effects of Bilateral GPI DBS on Freezing of Gait in PD

This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus (Gpi) on freezing of gait in patients with Parkinson's disease.

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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–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

(1) idiopathic PD, according to the MDS Parkinson's Disease Society Diagnostic Criteria17; (2) bilateral GPi-DBS implant according to a careful consideration of patients' symptom profiles (e.g., existence and severity of dyskinesia, dystonia, axial symptoms, or cognitive and mood problems); (3) onset of PD at or before 70 years of age; and (4) disease duration of more than 3 years at the time of surgery.

Patients were excluded if they had unstable vital signs or medical and psychiatric comorbidities at the time of the study.

Treatment and study plan

Primary outcomes

  1. Changs in the score of Timed Up and Go Test

    Time frame: baseline, 12 month

Secondary outcomes

  1. Change of the score in GFQ

    Time frame: baseline, 12 month

  2. Change of the score in FoG total time of TUG test

    Time frame: baseline, 12 month

  3. Change of the score in FoG Episodes of TUG test

    Time frame: baseline, 12 month

  4. Change of the score in Proportion of FoG of TUG test

    Time frame: baseline, 12 month

  5. Change of the score in Longest FoG duration of TUG test

    Time frame: baseline, 12 month

Other outcomes

  1. Change of the scores in MDS-UPDRS

    Time frame: baseline, 12 month

Sponsors and collaborators

Lead sponsor

Haiyan Zhou

Other

Registry information

Official study title

Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases

Acronym: PD GPI DBS

Important dates

Study start
2015
Primary completion
2020
Study completion
2025
First posted
Jul 24, 2017
Registry last updated
May 7, 2025

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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