Recruitment

Recruitment Status
Recruiting

Inclusion Criterias

Normal brain MRI
Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge)
Absence of dementia (Mini Mental State Examination ≥ 26)
...
Normal brain MRI
Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge)
Absence of dementia (Mini Mental State Examination ≥ 26)
Written informed consent
Age ranging from 18 to 75 years old
Absence of severe psychiatric diseases
Presence of fluctuations and/or dyskinesias

Exclusion Criterias

Poor compliance and unreasonable expectation
Secondary parkinsonism or multiple system atrophy
Illiteracy or insufficient language skills to complete the questionnaires
...
Poor compliance and unreasonable expectation
Secondary parkinsonism or multiple system atrophy
Illiteracy or insufficient language skills to complete the questionnaires
Simultaneous participation in another clinical tria
Presence of severe metabolic diseases
Severe cardiac/respiratory/renal/hepatic diseases
Women who are pregnant or breast feeding

Summary

Conditions
Parkinson's Disease
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Description

A total of 150 subjects will be recruited from the concurrent NCT01922388 study and followed up for two years. All patients will be evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III at baseline (one week before surge...

A total of 150 subjects will be recruited from the concurrent NCT01922388 study and followed up for two years. All patients will be evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III at baseline (one week before surgery) and at 6, 12 and 48 months postoperatively. Stimulation parameters setting: The first programming is performed at 3-4 weeks after surgery. Bilateral contacts are as cathode for monopolar configuration. The initial voltage, pulse width and frequency are bilaterally 1.0-1.5 V, 60 μs and 130 Hz for each individual, respectively. Voltage is gradually increased to a stable level first, until the optimal efficacy is achieved. Two weeks later, when patients came back to hospital for reprogramming, the voltage is also first adjusted to optimize the stimulation parameters. Either pulse width or frequency will be adjusted when increasing voltage more than 0.4 V for one time still can not get satisfactory outcomes. The frequency is adjusted when bilateral symptoms are unresponsive to voltage. Frequency is increased by 15-20 Hz for each time. Pulse width is then adjusted for the satisfactory clinical response of unilateral symptoms which are not satisfied after increasing voltage or frequency. Pulse width is increased to 90 μs if necessary (e.g. severe tremor). Groups: Patients are divided into two groups according to the parameter settings during follow-up. Group I: patients with voltage adjustment only. The pulse width is kept to 60 μs and frequency to 130 Hz constant throughout the follow-up period. Group II: patients with adjustment of more than two stimulation parameters (voltage, pulse width or frequency) during the follow-up.

Inclusion Criterias

Normal brain MRI
Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge)
Absence of dementia (Mini Mental State Examination ≥ 26)
...
Normal brain MRI
Idiopathic Parkinson's Disease with good response to levodopa(i.e. more than 30% improvement in the MDS-UPDRS Part III score after an acute levodopa challenge)
Absence of dementia (Mini Mental State Examination ≥ 26)
Written informed consent
Age ranging from 18 to 75 years old
Absence of severe psychiatric diseases
Presence of fluctuations and/or dyskinesias

Exclusion Criterias

Poor compliance and unreasonable expectation
Secondary parkinsonism or multiple system atrophy
Illiteracy or insufficient language skills to complete the questionnaires
...
Poor compliance and unreasonable expectation
Secondary parkinsonism or multiple system atrophy
Illiteracy or insufficient language skills to complete the questionnaires
Simultaneous participation in another clinical tria
Presence of severe metabolic diseases
Severe cardiac/respiratory/renal/hepatic diseases
Women who are pregnant or breast feeding

Locations

Guangzhou, Guangdong, 510080
Guangzhou, Guangdong, 510080

Tracking Information

NCT #
NCT01934881
Collaborators
  • Prince of Wales Hospital, Shatin, Hong Kong
  • Shenzhen Second People's Hospital
Investigators
  • Principal Investigator: Ling Chen, MD, PhD First Affiliated Hospital, Sun Yat-Sen University
  • Ling Chen, MD, PhD First Affiliated Hospital, Sun Yat-Sen University