NCT01953718

Brief Summary

The purpose of this study is to assess the impact of different parameters (voltage, pulse width, frequency) of subthalamic nucleus (STN) deep brain stimulation (DBS) on motor symptoms in patients with Parkinson's disease (PD).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

September 26, 2013

Last Update Submit

October 9, 2013

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (3)

  • Change of parameters (voltage, pulse width, frequency) during follow-up

    at 12 months

  • Change of UPDRS Part III score and the relation to parameters

    at 12 months

  • Changes of tremor, rigidity, bradykinesia and postural stability scores evaluated by UPDRS Part III and the relation to parameters

    at 12 months

Secondary Outcomes (1)

  • Change of daily levodopa equivalent dosage (LED) during follow-up

    at 12 months

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

PD patients who received bilateral STN DBS in the First Affiliated Hospital of Sun Yat-sen University

You may qualify if:

  • PD patients treated with bilateral STN DBS in the First Affiliated Hospital in the years 2008-2012

You may not qualify if:

  • Simultaneous participation in another clinical trial
  • Dementia (Mini Mental State Examination \< 26)
  • Removal of DBS electrodes
  • Loss to follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

September 26, 2013

First Posted

October 1, 2013

Study Start

July 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

CN(1)