Unilateral GPi vs Unilateral STN DBS in the Same Patient With PD

NCT04255719 | Completed

• 1 other identifier: 2020 UPS study
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Deep Brain Stimulation; Globus Pallidus Interna; Subthalamic Nucleus

Outcome Measures

Primary Outcomes (1)

• Difference in Timed Up-and-Go (TUG) task scores between treatment conditions in the on- and off- medication states

  Timed Up-and-Go task is a well-defined objective gait measurement. The task requires an individual to stand up, walk 5 m, turn, walk back, and sit down. The time taken to complete the test is strongly correlated with the level of functional mobility. This test will be videotaped and scored by two blinded neurologists.

  6 months

Secondary Outcomes (7)

• 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

  6 months

• Differences in Burg Balance Scale (BBS) scores between two treatment conditions in the on- and off- medication states.

  6 months

• Differences in postural angles between two treatment conditions in the on- and off- medication states.

  6 months

• Differences in Water Swallow Test (WST) scores between treatment conditions in the on- and off- medication states.

  6 months

• Differences in Swallowing Disturbance Questionnaire (SDQ) scores between treatment conditions in the on- and off- medication states.

  6 months

Study Arms (2)

Unilateral DBS of the subthalamic nucleus (STN)

EXPERIMENTAL

To deliver unilateral STN DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral STN DBS. The STN stimulation will be programmed as previous parameter configuration with optimal therapeutic benefits. Participants will be asked to complete a comprehensive set of assessments under unilateral STN stimulation in the off-medication state. 45 minutes after taking regular medication, participants need to complete the second set of assessments in the on-medication state.

Procedure: DBS

Unilateral DBS of the globus pallidus interna (GPi)

EXPERIMENTAL

To deliver unilateral GPi DBS, bilateral stimulation will be turned off for three hours, and then turn on the unilateral GPi DBS. The study protocol is identical to the intervention of unilateral STN DBS but it was done on a different day.

Procedure: DBS

Interventions

DBS PROCEDURE

Unilateral DBS for treatment of patients with PD

Unilateral DBS of the globus pallidus interna (GPi); Unilateral DBS of the subthalamic nucleus (STN)

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Poorly controlled depression or anxiety
• Past history of suicidal attempt

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Location

Related Publications (2)

• 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.

  PMID: 26424897 BACKGROUND

• 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.

  PMID: 29184712 BACKGROUND

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Throughout the study, all participants, independent raters/evaluators and statisticians will be blind to the treatment conditions and parameter configurations. Independent raters who are blind to the conditions will be responsible for the conduct of all the assessments. Participants are blind to the treatment conditions. Movement disorders clinician responsible for programming are blind to the study protocol. They are simply told to adjust parameter to optimize therapeutic effects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: March 1, 2020
• Primary Completion: February 27, 2021
• Study Completion: March 2, 2021
• Last Updated: March 4, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)