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Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease

Primary Purpose

Parkinson's Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
rTMS real stimulation stage1
rTMS shame stimulation stage1
rTMS real stimulation stage 2
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, slow-wave sleep, rTMS, motor symptom, progression

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Meet the clinically definite or clinically probable PD according to the MDS 2015 version. Chinese Han population (three generations), age greater than or equal to 50 years old, less than or equal to 80 years old, male or female. Hoehn-Yahr stages 1-4. The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period. Right-handed. The patient signed a written informed consent. Exclusion Criteria: Any form of Parkinsonism other than primary PD. Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment. Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score. Persons with mental disabilities. Pregnant women. There are contraindications for rTMS treatment. There are contraindications for MRI examination. Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI>=30. Patients who are addicted to alcohol, taking SSRIs, TCAs, sedative hypnotics, histamine antagonists and other drugs and food that may affect NREM and REM sleep structure. Those who are unwilling to participate in the study or unable to sign the informed consent form; and other circumstances that the researcher considers inappropriate to participate in the study. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    the early treatment group

    the control group (delayed treatment group)

    Arm Description

    stage1+stage2 real stimulation

    stage1 sham stimulation + stage2 real stimulation

    Outcomes

    Primary Outcome Measures

    Change of Motor Function in PD by Low Frequency rTMS Stimulation
    the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)[off] The higher the score, the more severe the motor dysfunction

    Secondary Outcome Measures

    Effects of low-frequency rTMS stimulation on motor symptoms
    the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII) [on] The higher the score, the more severe the motor dysfunction
    Measurement of improved balance function in patients with Parkinson's disease
    the score of Berg Balance Scale (BBS)[0-56] The higher the score, the better the balance
    Assessment of sleep structure in patients with Parkinson's disease
    Use polysomnography (PSG) to record the proportion of slow-wave sleep
    Effects of low-frequency rTMS stimulation on anxiety
    the score of Hamilton Anxiety Rating Scale（HAMA)[0-64] The higher the score, the more anxious
    Effects of low-frequency rTMS stimulation on cognition
    the score of Montreal Cognitive Assessment（Moca)[0-30] The lower the score, the more severe the cognitive dysfunction
    Effects of low-frequency rTMS stimulation on cortical excitability
    short-interval cortical inhibition(SICI)
    Effects of low-frequency rTMS stimulation on depression
    the score of Hamilton Depression Rating Scale（HAMD） Total score ≥ 20 points: may be mild or moderate depression; The higher the score, the more depressed
    Assessment of daytime sleepiness in patients with Parkinson's disease
    the score of The Epworth Sleeping Scale(ESS)[0-24] The higher the score, the more lethargic
    Effects of low-frequency rTMS stimulation on gait
    Use a quantitative gait analysis system to analyze the change of gait

    Full Information

    First Posted
    July 11, 2023
    Last Updated
    August 15, 2023
    Sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06002581
    Brief Title
    Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
    Official Title
    Clinical Study on the Efficacy and Safety of rTMS Regulating Slow-wave Sleep to Delay the Progression of Parkinson's Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 29, 2023 (Anticipated)
    Primary Completion Date
    July 28, 2026 (Anticipated)
    Study Completion Date
    July 28, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    At present, no drug therapy has been proven to delay the progression of Parkinson's disease (PD). rTMS, as a non-invasive neuromodulation method, can regulate Slow-wave sleep (SWS). SWS is recognized closely related to neurodegeneration. However, there has been no clinical studies on if rTMS could delay the progression of PD by regulating SWS. The main purpose of this study is to explore the changes of SWS in non-rapid eye movement (NREM) sleep period in PD patients by using rTMS, and the relationship with potential improvements of SWS and motor symptom delay. The study aims to find a potential new treatment strategy to delay the neurodegenerative process in PD patients by modulating SWS by rTMS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Parkinson's Disease
    Keywords
    Parkinson's disease, slow-wave sleep, rTMS, motor symptom, progression

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    the early treatment group
    Arm Type
    Experimental
    Arm Description
    stage1+stage2 real stimulation
    Arm Title
    the control group (delayed treatment group)
    Arm Type
    Other
    Arm Description
    stage1 sham stimulation + stage2 real stimulation
    Intervention Type
    Device
    Intervention Name(s)
    rTMS real stimulation stage1
    Intervention Description
    In the first stage, the early treatment group use low-frequency rTMS real stimulation,
    Intervention Type
    Device
    Intervention Name(s)
    rTMS shame stimulation stage1
    Intervention Description
    In the first stage, the control group (delayed treatment group) all use sham stimulation.
    Intervention Type
    Device
    Intervention Name(s)
    rTMS real stimulation stage 2
    Intervention Description
    In the second stage, both the early treatment group and the control group (delayed treatment group) will be treated with true stimulation low-frequency rTMS.
    Primary Outcome Measure Information:
    Title
    Change of Motor Function in PD by Low Frequency rTMS Stimulation
    Description
    the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII)[off] The higher the score, the more severe the motor dysfunction
    Time Frame
    Day14
    Secondary Outcome Measure Information:
    Title
    Effects of low-frequency rTMS stimulation on motor symptoms
    Description
    the score of Unified Parkinson's Disease Rating ScaleⅢ (UPDRSIII) [on] The higher the score, the more severe the motor dysfunction
    Time Frame
    Day28,Day56
    Title
    Measurement of improved balance function in patients with Parkinson's disease
    Description
    the score of Berg Balance Scale (BBS)[0-56] The higher the score, the better the balance
    Time Frame
    Day14,Day28,Day56
    Title
    Assessment of sleep structure in patients with Parkinson's disease
    Description
    Use polysomnography (PSG) to record the proportion of slow-wave sleep
    Time Frame
    Day14,Day28,Day56
    Title
    Effects of low-frequency rTMS stimulation on anxiety
    Description
    the score of Hamilton Anxiety Rating Scale（HAMA)[0-64] The higher the score, the more anxious
    Time Frame
    Day14,Day28,Day56
    Title
    Effects of low-frequency rTMS stimulation on cognition
    Description
    the score of Montreal Cognitive Assessment（Moca)[0-30] The lower the score, the more severe the cognitive dysfunction
    Time Frame
    Day14,Day28,Day56
    Title
    Effects of low-frequency rTMS stimulation on cortical excitability
    Description
    short-interval cortical inhibition(SICI)
    Time Frame
    Day14,Day28
    Title
    Effects of low-frequency rTMS stimulation on depression
    Description
    the score of Hamilton Depression Rating Scale（HAMD） Total score ≥ 20 points: may be mild or moderate depression; The higher the score, the more depressed
    Time Frame
    Day14,Day28,Day56
    Title
    Assessment of daytime sleepiness in patients with Parkinson's disease
    Description
    the score of The Epworth Sleeping Scale(ESS)[0-24] The higher the score, the more lethargic
    Time Frame
    Day14,Day28,Day56
    Title
    Effects of low-frequency rTMS stimulation on gait
    Description
    Use a quantitative gait analysis system to analyze the change of gait
    Time Frame
    Day14,Day28,Day56
    Other Pre-specified Outcome Measures:
    Title
    Effects of low-frequency rTMS stimulation on brain connectivity in the PD brain
    Description
    functional magnetic resonance imaging (fMRI) (Default mode network, DMN）
    Time Frame
    Day0,Day14,Day28
    Title
    Changes in salivary melatonin levels
    Description
    salivary melatonin levels(Fasting)
    Time Frame
    Day0,Day14,Day28,Day56

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Meet the clinically definite or clinically probable PD according to the MDS 2015 version. Chinese Han population (three generations), age greater than or equal to 50 years old, less than or equal to 80 years old, male or female. Hoehn-Yahr stages 1-4. The dose of levodopa drug therapy was stable three weeks before enrollment and during the follow-up period. Right-handed. The patient signed a written informed consent. Exclusion Criteria: Any form of Parkinsonism other than primary PD. Those who have received neurosurgical intervention or stereotaxic brain surgery for PD, or have previously received TMS treatment. Cognitive dysfunction (MMSE ≤ 24 points) or those who cannot cooperate with the scale score. Persons with mental disabilities. Pregnant women. There are contraindications for rTMS treatment. There are contraindications for MRI examination. Baseline PSG suggests other sleep disorders such as moderate to severe OSAS; BMI>=30. Patients who are addicted to alcohol, taking SSRIs, TCAs, sedative hypnotics, histamine antagonists and other drugs and food that may affect NREM and REM sleep structure. Those who are unwilling to participate in the study or unable to sign the informed consent form; and other circumstances that the researcher considers inappropriate to participate in the study. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaoying Zhu, doctor
    Phone
    +86 21 63240090
    Email
    docxiaoying@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease

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