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Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study (ADP)

Primary Purpose

Parkinson Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
Ruijin Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring deep brain stimulation, subthalamic nucleus, globus pallidus interna, asymmetric deep brain stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria for Parkinson's disease
  • Aged more than 18 years
  • Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III
  • the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition
  • Compliance with written informed consent

Exclusion Criteria:

  • Atypical parkinsonian syndrome
  • History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery
  • Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent
  • Presence of anatomical abnormalities in the target region
  • Clinically significant medical history or that increases pre-/post-operative complications
  • Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Asymmetric DBS group

    Arm Description

    In this arm, a one-staged combined unilateral STN and contralateral GPi DBS will be implanted into PD patients. For postural instability and gait difficulty (PIGD)-dominant patients, the GPi in the side contralateral to the leg with longer step length will be targeted. For tremor-dominant (TD) patients, the STN in the side contralateral to the body side that mostly affected will be targeted. For PD patients of mixed type, the choice of target will depend on the judgement of a multidisciplinary team based on clinical features.

    Outcomes

    Primary Outcome Measures

    Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III)
    Score ranges from 0 to 132, higher scores mean a worse outcome.

    Secondary Outcome Measures

    Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV
    Score ranges from 0 to 128, higher scores mean a worse outcome.
    Time-Up-Go (TUG) task
    Berg Balance Scale, BBS
    Score ranges from 0 to 132, higher scores mean a better outcome.
    Gait and Falls Questionnaire, GFQ
    Score ranges from 0 to 64, higher scores mean a worse outcome.
    Montreal Cognitive Assessment (MoCA)
    Beck Depression Inventory, BDI
    Beck Anxiety Inventory, BAI
    Apathy Estimation Scale, AES
    Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF
    True-or-false questions screening the obsessive-compulsive behaviors in parkinson's disease
    Epworth Sleepiness Scale, ESS
    Non-Motor Symptoms Scale, NMSS
    Score ranges from 0 to 360, higher scores mean a worseoutcome.
    Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT
    8-item Parkinson's Disease Questionnaire (PDQ-8)
    5-Level EuroQol Five Dimensions Questionnaire, EQ-5D-5L
    Levodopa Equivalent Daily Dose, LEDD
    Adverse Events, Severe Adverse Events

    Full Information

    First Posted
    October 30, 2020
    Last Updated
    December 22, 2020
    Sponsor
    Ruijin Hospital
    Collaborators
    Huashan Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Second Affiliated Hospital of Soochow University, Tianjin Huanhu Hospital, Guangzhou General Hospital of Guangzhou Military Command, The Affiliated Hospital of Xuzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04616521
    Brief Title
    Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study
    Acronym
    ADP
    Official Title
    Asymmetric Deep Brain Stimulation for Parkinson's Disease: A Multicenter, Prospective, Single Arm, Open Label Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    November 30, 2029 (Anticipated)
    Study Completion Date
    November 30, 2030 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ruijin Hospital
    Collaborators
    Huashan Hospital, Shanghai Tongji Hospital, Tongji University School of Medicine, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Guangzhou Medical University, West China Hospital, Second Affiliated Hospital of Soochow University, Tianjin Huanhu Hospital, Guangzhou General Hospital of Guangzhou Military Command, The Affiliated Hospital of Xuzhou Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Deep brain stimulation (DBS) is an efficacious neurosurgical treatment for moderate-to-late stage Parkinson's disease (PD). The subthalamic nucleus (STN) and globus pallidus interna (GPi) are two targets extensively studied and used worldwide in treating PD. Although the conventional SYMMETRIC bilateral STN and GPi DBS are shown to be effective in controlling motor symptoms such as bradykinesia, tremor, and dyskinesia, each target has its pros and cons in terms of axial symptom control, medication reduction, cognitive decline, and programming. Therefore, we speculate that an ASYMMETRIC bilateral implantation of DBS leads (i.e., combined unilateral STN and contralateral GPi DBS) may be able to bring the greatest clinical benefits to PD patients by taking advantage of both bilateral STN and GPi DBS at the same time. The preliminary retrospective study containing eight PD patients undergoing asymmetric implantation of DBS demonstrated the safety and efficacy of this treatment strategy during short-term follow-up. This multicenter, single arm, open label study aims to prospectively investigate during the long-term follow-up the safety and efficacy of asymmetric DBS for PD in terms of motor and nonmotor symptoms, medication reduction, cognitive decline, and quality of life.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson Disease
    Keywords
    deep brain stimulation, subthalamic nucleus, globus pallidus interna, asymmetric deep brain stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1000 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Asymmetric DBS group
    Arm Type
    Experimental
    Arm Description
    In this arm, a one-staged combined unilateral STN and contralateral GPi DBS will be implanted into PD patients. For postural instability and gait difficulty (PIGD)-dominant patients, the GPi in the side contralateral to the leg with longer step length will be targeted. For tremor-dominant (TD) patients, the STN in the side contralateral to the body side that mostly affected will be targeted. For PD patients of mixed type, the choice of target will depend on the judgement of a multidisciplinary team based on clinical features.
    Intervention Type
    Procedure
    Intervention Name(s)
    Deep brain stimulation
    Intervention Description
    The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.
    Primary Outcome Measure Information:
    Title
    Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part III (MDS UPDRS-III)
    Description
    Score ranges from 0 to 132, higher scores mean a worse outcome.
    Time Frame
    Followed for minimum of 7 years
    Secondary Outcome Measure Information:
    Title
    Movement Disorder Society-Sponsored Unified Parkinson's Disease Rating Scale - Part I, II, IV
    Description
    Score ranges from 0 to 128, higher scores mean a worse outcome.
    Time Frame
    Followed for minimum of 7 years
    Title
    Time-Up-Go (TUG) task
    Time Frame
    Followed for minimum of 7 years
    Title
    Berg Balance Scale, BBS
    Description
    Score ranges from 0 to 132, higher scores mean a better outcome.
    Time Frame
    Followed for minimum of 7 years
    Title
    Gait and Falls Questionnaire, GFQ
    Description
    Score ranges from 0 to 64, higher scores mean a worse outcome.
    Time Frame
    Followed for minimum of 7 years
    Title
    Montreal Cognitive Assessment (MoCA)
    Time Frame
    Followed for minimum of 7 years
    Title
    Beck Depression Inventory, BDI
    Time Frame
    Followed for minimum of 7 years
    Title
    Beck Anxiety Inventory, BAI
    Time Frame
    Followed for minimum of 7 years
    Title
    Apathy Estimation Scale, AES
    Time Frame
    Followed for minimum of 7 years
    Title
    Questionnaire for Impulsive-Compulsive Disorders in Parkinson's Disease-Current Full, QUIP-CF
    Description
    True-or-false questions screening the obsessive-compulsive behaviors in parkinson's disease
    Time Frame
    Followed for minimum of 7 years
    Title
    Epworth Sleepiness Scale, ESS
    Time Frame
    Followed for minimum of 7 years
    Title
    Non-Motor Symptoms Scale, NMSS
    Description
    Score ranges from 0 to 360, higher scores mean a worseoutcome.
    Time Frame
    Followed for minimum of 7 years
    Title
    Scales for Outcomes in PArkinson's disease - Autonomic, SCOPA-AUT
    Time Frame
    Followed for minimum of 7 years
    Title
    8-item Parkinson's Disease Questionnaire (PDQ-8)
    Time Frame
    Followed for minimum of 7 years
    Title
    5-Level EuroQol Five Dimensions Questionnaire, EQ-5D-5L
    Time Frame
    Followed for minimum of 7 years
    Title
    Levodopa Equivalent Daily Dose, LEDD
    Time Frame
    Followed for minimum of 7 years
    Title
    Adverse Events, Severe Adverse Events
    Time Frame
    Followed for minimum of 7 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with idiopathic Parkinson's disease based on the MDS clinical diagnostic criteria for Parkinson's disease Aged more than 18 years Levodopa challenge test indicating a preoperative levodopa responsiveness over 24% based on MDS UPDRS-III the modified Hoehn-Yahr Scale between 2 and 4 under on-medication condition Compliance with written informed consent Exclusion Criteria: Atypical parkinsonian syndrome History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with the intracranial surgery Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent Presence of anatomical abnormalities in the target region Clinically significant medical history or that increases pre-/post-operative complications Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dianyou Li, MD, PhD
    Phone
    13817864569
    Email
    ldy11483@rjh.com.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chencheng Zhang, MD, PhD
    Phone
    18217122884
    Email
    i@cczhang.org

    12. IPD Sharing Statement

    Learn more about this trial

    Asymmetric DBS for PD : A Multicenter, Prospective, Single Arm, Open Label Study

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