Voltage Only Adjustment Versus Multiple Parameters Adjustment of Bilateral STN DBS Treatment in PD Patients.

NCT01934881 | Completed

• 1 other identifier: [2013] 19
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The programming of subthalamic nucleus (STN) deep brain stimulation (DBS) for Parkinson's disease (PD) is complex work because the parameter setting has not been standardized so far. The objective of the present study is to set up a standardized programming algorithm for Chinese PD patients treated with bilateral STN DBS.

Conditions

Parkinson's Disease

Keywords

Deep Brain Stimulation; programming

Outcome Measures

Primary Outcomes (1)

• Changes in motor symptoms (tremor, rigidity, bradykinesia and postural stability) evaluated by MDS-UPDRS Part III in off medication /on stimulation state

  Motor subscores

  From baseline to 12 and 48 months

Secondary Outcomes (2)

• Changes in 39-item Parkinson's Disease Questionnaire (PDQ-39) scores

  From baseline to 12 and 48 months

• Changes in levodopa equivalent daily dosage (LEDD)

  From baseline to 12 and 48 months

Study Arms (2)

group I

Voltage adjustment only

Device: voltage adjustment only

group II

Multiple parameters adjustment

Device: Multiple parameters adjustment

Interventions

voltage adjustment only DEVICE

Only voltage will be adjusted in all programming sections.

group I

Multiple parameters adjustment DEVICE

More than one parameter, including voltage, frequency and pulse width, will be adjusted in the programming sections.

group II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

PD Patients are selected from the outpatient department of three centres.

You may qualify if:

• The patients with the idiopathic Parkinson's disease with good response to levodopa medication (i.e. more than 30% improvement in the MDS-UPDRS Part III score of the motor function examination(Goetz et al., 2008b) after an acute levodopa medication challenge);
• Disease duration ≥4 years;
• The patients with the fluctuations and/or dyskinesias;
• The patients with age ranging from 18 to 75 years old;
• The patients with normal brain on the MRI;
• The patients with the absence of dementia (Mini-Mental State Examination scores of≥ 26) ;
• The patients with the absence of severe psychiatric diseases;
• The patients who provided the written informed consent

You may not qualify if:

• The patients with severe metabolic diseases;
• The patients with severe cardiac/respiratory/renal/hepatic diseases;
• The patients having secondary parkinsonism or multiple system atrophies;
• The patients who illiterate or having insufficient language skills to complete the questionnaires;
• The patients who had poor compliance and unreasonable expectation;
• Women who were pregnant or breast feeding;
• The patients with the simultaneous participation in another clinical trial

Sponsors & Collaborators

• Chen Ling: lead
• Prince of Wales Hospital, Shatin, Hong Kong: collaborator
• Shenzhen Second People's Hospital: collaborator

Study Sites (1)

the First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

• Xu SH, Yang C, Xian WB, Gu J, Liu JL, Jiang LL, Ye J, Liu YM, Guo QY, Zheng YF, Wu L, Chen WR, Pei Z, Chen L. Voltage adjustment improves rigidity and tremor in Parkinson's disease patients receiving deep brain stimulation. Neural Regen Res. 2018 Feb;13(2):347-352. doi: 10.4103/1673-5374.226406.

  PMID: 29557387 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Ling Chen, MD, PhD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: August 30, 2013
• First Posted: September 4, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CN (1)