Clinical trial NCT04255719: Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD
Official title: Unilateral Pallidal vs Unilateral Subthalamic Nucleus Deep Brain Stimulation in the Same Patient With Parkinson Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Deep Brain Stimulation
Globus Pallidus Interna
Subthalamic Nucleus
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 9
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two main targets in the deep brain stimulation (DBS) treatment for Parkinson's disease (PD). Large randomized controlled trials, in which patients of comparable clinical and demographics were randomized to either GPi DBS or STN DBS, have demonstrated equal effects of both targets in motor symptom improvement, the superiority of STN DBS in the medication reduction and the potential advantage of GPi DBS for cognitive, psychiatric and axial aspects. Unfortunately, in such a highly heterogeneous disease of PD, many of these randomized controlled trials didn't include sufficient subjects and thereby yielded inconsistent results. Moreover, most studies are investigating the difference between GPi and STN in different patients.

In order to address the problem, an intra-patient comparison will be made by investigating the acute turning-on effects of unilateral STN stimulation versus unilateral GPi stimulation on axial symptoms, cognition and also cardinal symptoms within each individual patient who received the treatment of combined unilateral STN and contralateral GPi DBS. Axial symptoms including gait, balance and posture, motor symptoms and cognition are comprehensively assessed under two treatment conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson's disease
* Aged between 55 and 75 years, both male and female
* Patients who have undergone combined unilateral STN and contralateral GPi DBS for more than 6 months
* A Hoehn-Yahr (H-Y) stage of less than 4 in the off-medication state
* A left-extremity to right-extremity ratio of less than 0.15 on the Unified Parkinson's Disease Rating Scale part Ⅲ (UPDRS-Ⅲ) in the both off-medication and on-medication states

Exclusion Criteria:

* History of serious psychosis
* History of intractable epilepsy (i.e., seizures)
* Diagnosed by the investigators that patients with severe cardiac, liver and kidney diseases, or other serious health conditions
* Dementia (A Mini-Mental State Examination (MMSE) score of \< 24), inability to comprehend the experimental protocol or voluntarily provide informed consent
* Lack of cooperation
* Additional reasons for exclusion at the discretion of the clinical investigator
* Poorly controlled depression or anxiety
* Past history of suicidal attempt

Primary outcomes:
measure: Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states
timeFrame: 6 months
Secondary outcomes:
measure: Differences in total Uniﬁed Parkinson's Disease Rating Scale Part Ⅲ (UPDRS Ⅲ) scores between two treatment conditions in the on- and off- medication states
timeFrame: 6 months
measure: Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.
timeFrame: 6 months
measure: Differences in postural angles between two treatment conditions in the on- and off- medication states.
timeFrame: 6 months
measure: Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.
timeFrame: 6 months
measure: Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.
timeFrame: 6 months
measure: Differences in voice parameters between treatment conditions in the on- and off- medication states.
timeFrame: 6 months
measure: Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states.
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital
state: Shanghai
Study officials:
References:
citation: Yamada K, Shinojima N, Hamasaki T, Kuratsu J. Subthalamic nucleus stimulation improves Parkinson's disease-associated camptocormia in parallel to its preoperative levodopa responsiveness. J Neurol Neurosurg Psychiatry. 2016 Jul;87(7):703-9. doi: 10.1136/jnnp-2015-310926. Epub 2015 Sep 30.
citation: Lizarraga KJ, Luca CC, De Salles A, Gorgulho A, Lang AE, Fasano A. Asymmetric neuromodulation of motor circuits in Parkinson's disease: The role of subthalamic deep brain stimulation. Surg Neurol Int. 2017 Oct 24;8:261. doi: 10.4103/sni.sni_292_17. eCollection 2017.