パーキンソン病における神経可塑性
初期パーキンソン病における運動系の可塑性
The purpose of this project is to increase our understanding of the early state and temporal evolution of neuroplastic changes in the cortex and subthalamic nucleus (STN) of people with PD, and the relationship of these changes to the emergence and expression of PD motor and non-motor signs. Neurophysiological biomarkers derived from this work may be important for the early detection and prediction of progression of disease. They can also provide the means to assess the efficacy of interventions designed to prevent or slow disease progression.
調査の概要
詳細な説明
This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI), from Dr. Noam Harel's protocol IRB# STUDY00008096, and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. The TMS experiment will use a Magstim Bistimn 2002 transcranial magnetic stimulation (TMS) unit and standard figure-of-eight coil (70 mm diameter) to deliver stimulation on the surface of the scalp. Stimulation will be delivered using either a single pulse or with a paired-pulse protocol (two stimuli, through the same TMS coil at inter-stimulus intervals of 50 or 80 ms). All surface EMG signals will be pre-amplified within the sensor and sent wirelessly via blue-tooth connection to a Delsys data collection system. Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function will used to assess behavioral status at baseline and 30-36 months later.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Minnesota
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Minneapolis、Minnesota、アメリカ、55455
- University of Minnesota
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults diagnosed with Parkinson's Disease (early diagnosis, currently untreated) and age- and sex-matched healthy controls
説明
Inclusion Criteria:
Participants with PD
- Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria
- Not receiving levodopa or dopamine agonist to treat PD (at baseline)
- Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters Healthy Controls
- Age- (+/- 3 years) and sex-matched to participants with PD
- Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters
Exclusion Criteria:
- Dementia diagnosis and/or a University of California Brief Assessment of Capacity to Consent (UBACC) score and MacCAT-CR score indicating impaired capacity to consent
- History of musculoskeletal disorders that significant affect movement of lower or upper limbs as determined at the time of enrollment
- History of bipolar disorder, post-traumatic stress disorder or major depressive disorder
- Other significant neurological disorders that may affect participation or performance in the study
- Implanted DBS or other neurosurgeries to treat PD
- Pregnancy
Additional exclusion criteria for TMS experiments (note that individuals who are excluded from the TMS experiment still have the opportunity to participate in the other data collection sessions):
- History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury
- Recent history of frequent syncope (fainting) episodes in response to blood, emotional stress, or sensory triggers.
- Intracranial metallic or magnetic devices (e.g. cochlear implant, deep brain stimulator)
- Pacemaker or any implanted device
- History of surgery on blood vessels, brain, or heart
- Unexplained, recurring headaches or concussion within the last six months
- Severe hearing impairment
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Early (untreated) Parkinson's Disease
Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria. |
This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI) and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function |
|
Healthy Controls
Age- and sex-matched healthy controls. |
This project will use neuroimaging (7T MRI: structural, diffusion and rest-state functional MRI) and non-invasive brain stimulation (TMS: PAS. SAI) techniques to quantify structural and functional changes in brain function. Quantitative assessments of motor function (gait, gait initiation, reactive balance, bradykinesia, repetitive alternating movements, rigidity, stop-signal reaction time), and neuropsychological function |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in volume of Subthalamic Nucleus
時間枠：Baseline, 30-36 months
|
The volume of the subthalamic nucleus is assessed using MRI and reported in millimeters cubed (mm^3). |
Baseline, 30-36 months
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Change in fractional Anisotropy of Subthalamic Nucleus
時間枠：Baseline, 30-36 months
|
Fractional anisotropy, measured using MRI, is a unit-less value between zero and one that describes the degree of anisotropy of water diffusion in a specified brain area. Higher values indicate a greater degree of anisotropy, while a score of zero indicates isotropic diffusion. |
Baseline, 30-36 months
|
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Change in cortico-STN Connectivity
時間枠：Baseline, 30-36 months
|
Cortico-Subthalamic nucleus connectivity is measured using MRI and reported as a z score (unitless). |
Baseline, 30-36 months
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Change in paired Associative Stimulation-Motor Evoked Potential (PAS-MEP)
時間枠：Baseline, 30-36 months
|
Motor evoked potential is measured as the amplitude of change in target muscle electrical activity following transcranial magnetic stimulation (TMS) and reported in units of millivolts (mV). |
Baseline, 30-36 months
|
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Change in Mattis Dementia Rating Scale 2 (DRS-2)
時間枠：Baseline, 30-36 months
|
The DRS-2 consists of 24 items, rated on a scale from 0 to 6. Item scores are combined into five subscales: attention (8 items), initiation/perseveration (11 items), construction (6 items), conceptualization ( 6 items), and memory (5 items). These five subscale scores are summed to calculate a total score ranging from from 0 to 144 points, with lower scores indicating worse performance due to dementia. |
Baseline, 30-36 months
|
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Change in Rey Complex Figure and Matrix Reasoning of the Wechsler Adult Intelligence Scale - IV
時間枠：Baseline, 30-36 months
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Measure of visuospatial construction, memory and reasoning. Scaled score based on age norms. |
Baseline, 30-36 months
|
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Change in Stroop Color Word Test
時間枠：Baseline, 30-36 months
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Measure of response inhibition, selective attention and processing. Scaled score based on age norms. |
Baseline, 30-36 months
|
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Change in Wisconsin Card Sorting Test
時間枠：Baseline, 30-36 months
|
Measures cognitive flexibility, abstract reasoning, and set-shifting. Scaled score based on age norms. |
Baseline, 30-36 months
|
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Change in Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Subtest
時間枠：Baseline, 30-36 months
|
Measures cognitive flexibility, abstract reasoning, and set-shifting. Scaled score based on age norms. |
Baseline, 30-36 months
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Change in Brief Visuospatial Memory Test - Revised (BVMT-R)
時間枠：Baseline, 30-36 months
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Measure of non-verbal (visuospatial) learning and memory abilities. Scaled score based on age norms. |
Baseline, 30-36 months
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。