Parkinson DiseasePD GPI DBSNCT03227250
Effects of Bilateral GPI DBS on Freezing of Gait in PD
An observational study of Parkinson Disease, run by Haiyan Zhou at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2015to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Parkinson's Disease who underwent GPI DBS.
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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases
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.
- Conditions
- Parkinson Disease
- Keywords
- freezing of gait, Parkinson disease, GPi
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GPI DBS | patients who had freezing of gait and underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changs in the score of Timed Up and Go Test
Measured: baseline, 12 month
Secondary outcomes (5)
Change of the score in GFQ
Measured: baseline, 12 month
Change of the score in FoG total time of TUG test
Measured: baseline, 12 month
Change of the score in FoG Episodes of TUG test
Measured: baseline, 12 month
Change of the score in Proportion of FoG of TUG test
Measured: baseline, 12 month
Change of the score in Longest FoG duration of TUG test
Measured: baseline, 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start1 Nov 2015
- Primary completion1 Jan 2020
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haiyan Zhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Haiyan Zhou, Ruijin Hospital
- Investigators
- Haiyan Zhou, Principal investigator, Ruijin HospitalShengdi Chen, Principal investigator, Ruijin HospitalDianyou Li, Principal investigator, Ruijin HospitalBomin Sun, Principal investigator, Ruijin HospitalWei Hu, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227250
- Sponsor's protocol ID
- GPIFOG
- Acronym
- PD GPI DBS
- Status last verified
- Mar 2020
- First submitted
- 20 Jul 2017
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases
- ClinicalTrials.gov ID
- NCT03227250
- Acronym / sponsor ID
- PD GPI DBS / GPIFOG
- Conditions
- Parkinson Disease
- Keywords
- freezing of gait, Parkinson disease, GPi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Haiyan ZhouUniversity, hospital or other
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPI DBS | – | –patients who had freezing of gait and underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's Disease who underwent GPI DBS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changs in the score of Timed Up and Go Test
Time frame: baseline, 12 month
5 secondary outcomes
Change of the score in GFQ
Time frame: baseline, 12 month
Change of the score in FoG total time of TUG test
Time frame: baseline, 12 month
Change of the score in FoG Episodes of TUG test
Time frame: baseline, 12 month
Change of the score in Proportion of FoG of TUG test
Time frame: baseline, 12 month
Change of the score in Longest FoG duration of TUG test
Time frame: baseline, 12 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haiyan Zhou principal investigator
Ruijin Hospital
Shengdi Chen principal investigator
Ruijin Hospital
Dianyou Li principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Haiyan Zhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changs in the score of Timed Up and Go Test (time frame: baseline, 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.