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Completed

NCT Number: NCT04255719

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deep Brain Stimulation Globus Pallidus Interna Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Subthalamic Nucleus Synucleinopathies

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Functional neurosurgery of Shanghai jiaotong university affiliated Ruijin hospital

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBS

Procedure

Unilateral DBS for treatment of patients with PD

Primary outcomes

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

    Time frame: 6 months

    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.

Secondary outcomes

  1. 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

    Time frame: 6 months

    Unified Parkinson's Disease Rating Scale Part Ⅲ measures the motor severity of Parkinson's disease. UPDRS Ⅲ score has a range of 0 (no symptoms) to 132 (severe disease symptoms).

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

    Time frame: 6 months

    Burg Balance Scale measures patients' static and dynamic balance abilities. BBS score has a range of 0 (severe balance problems) to 56 (no balance problems).

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

    Time frame: 6 months

    The measurement of postural angles is the same as the paper (Yamada et al) published in J Neurol Neurosurg Psychiatry

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

    Time frame: 6 months

    The Water Swallow Test is frequently used in clinical practice as a functional assessment to detect dysphagia, with stage 1 indicating severe dysphagia and stage 6 indicating normal swallowing function.

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

    Time frame: 6 months

    The Swallowing Disturbance Questionnaire is created as a self-rated dysphagia screening tool in PD, with a range of 0 (normal swallowing function) to 42 (severe dysphagia).

  6. Differences in voice parameters between treatment conditions in the on- and off- medication states.

    Time frame: 6 months

    Voice recording at a sampling rate of 44.1 kHz using 16-bit quantification will be conducted in a sound-treated room using a microphone and a digital voice recorder with a mouth-to-microphone distance of 15 cm. The recorded voices will then be used for a composit acoustic analysis.

  7. Differences in Voice Handicap Index (VHI) between treatment conditions in the on- and off- medication states.

    Time frame: 6 months

    The Voice Handicap Index is a self-administered instrument, comprising 30 items on voice-related dysfunction. VHI has a range of 0 (normal voice function) to 120 (severe voice dysfunction).

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Unilateral Pallidal vs Unilateral Subthalamic Nucleus Deep Brain Stimulation in the Same Patient With Parkinson Disease: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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