Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia (DBSMER)
2022年10月26日 更新者：Markey Olson、St. Joseph's Hospital and Medical Center, Phoenix
The pathology of Parkinson's disease (PD) and the mechanism of Deep Brain Stimulation surgery (DBS) are not completely understood.
The recording data that is used routinely as part of the procedure to map the target structures, however, may be analyzed in order to better understand the neural network dynamics in PD.
The purpose of the study is to perform simultaneous neural recordings from sub-cortical structures (e.g.
subthalamic nucleus [STN] or globus pallidus internus [GPi]) and the cerebral cortex.
These simultaneous recordings may provide insight in the pathology of PD and the mechanism of DBS.
The researchers will also study the effects of anesthesia level on neuron synchronization .
Recordings with micro-ECoG grid electrodes in the cortex show improved spatial resolution and these will be used to gain better understanding of cortical network dynamics and the synchronization with subcortical structures.
調査の概要
詳細な説明
Subjects will be identified exclusively from the researchers' clinical practice for evaluation of DBS surgical candidacy for Parkinson's disease.
Once it is determined that a patient is an appropriate candidate for DBS placement (multidisciplinary team consensus) and has met inclusion criteria,the researchers will discuss the study with the subject and explain the rationale for the study as well as the implications the subject's participation has to their treatment.
Informed consent will be obtained prior to study procedures being performed.
Subjects will be in the study from the time of enrollment before surgery until all post-operative visits and tests are completed, usually by 6 months after surgery.
Follow-up during this time will consist of the standard follow-up schedule that all patients who undergo DBS follow.
This includes a clinic visit at 10-14 days, 12 weeks, and 6 months after DBS surgery.
Subjects will also have a follow-up neurocognitive evaluation consisting of the same evaluative tests administered pre-operatively.
These post-operative visits are standard for all patients undergoing DBS for Parkinson's.
研究の種類
介入
入学 (実際)
34
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Arizona
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Phoenix、Arizona、アメリカ、85013
- St. Joseph's Hospital and Medical Center
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～85年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Parkinson's disease per Queens Square criteria
- Appropriate DBS candidate for multi-disciplinary team consensus
- Age 18 - 85 years of age
- Motor skills allowing for capability to complete evaluations
- Medically cleared for undergoing anesthesia and DBS surgery
Exclusion Criteria:
- Dementia per DSM-V criteria
- Medical or other condition precluding MRI
- History of supraspinal CNS disease other than PD
- Alcohol use of more than 4 drinks per day
- Pregnancy
- History of suicide attempt
- Currently uncontrolled clinically significant depression (BDI>20)
- History of schizophrenia, delusions, or currently uncontrolled visual hallucinations
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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他の：Deep Brain Stimulation
After informed consent is obtained, the patients will undergo routine DBS pre-operative evaluation and diagnostic testing.
This includes a pre-operative 3T-MRI with and without gadolinium as well as pre-operative medical clearance by the patient's PCP or general practitioner and/or other medical specialist if necessary.
They will also receive a baseline clinical evaluation including both motor function (Unified Parkinson's Disease Rating Scale on and off anti-parkinsonian medication) quality of life assessment (Parkinson's disease Questionnaire-39) and a full neuropsychological evaluation, if not already completed as part of the routine DBS candidacy evaluation within 2 months of surgery.
Subjects will have medical clearance from their specialists and be be evaluated by an internal medicine physician prior to surgery and cleared to proceed.
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Subjects will have awake or asleep DBS surgery with STN or GPi placement.
Microelectrode recordings will define the electrophysiological target prior to lead implantation.
Cortical recordings will be done using µECoG grids (2.0 x 0.8 cm) placed over the cortex through the same burr hole used for lead implantation.
Neural recordings will be made continuously throughout the procedure: before, during, and after DBS, and at all levels of anesthesia.
A pulse generator will be connected and implanted either during the operation or within 7-10 days post-operatively.
Subjects will be admitted overnight for observation with anticipated discharge the next morning.
The researchers will also be collecting other routine data points (length of surgery, stereotactic accuracy, length of hospital stay, and post-operative complications).
他の名前：
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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 |
|---|---|---|
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Neural Recordings
時間枠：pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative
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Simultaneous neural recordings from sub-cortical structures (e.g.
subthalamic nucleus [STN] or globus pallidus internus [GPi]) and the cerebral cortex will be collected.
Recordings include action potentials and local field potentials from sub-cortical structures while subdural microelectrocorticography grids will be used to record local field potential from the cerebral cortex.
Time, frequency, and phase relationships between action potentials and local field potentials will also be studied in the context of the level of anesthesia.
Analysis of these simultaneous recordings, including assessing any changes, may provide insight in the pathology of PD and the mechanism of DBS.
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pre-operative; intra-operative ; 10-14 post-operative; 12 week post-operative; 6 months post-operative
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Francisco A Ponce, MD、Barrow Brain and Spine physician with SJHMC privileges
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2016年2月1日
一次修了 (実際)
2022年3月1日
研究の完了 (実際)
2022年3月1日
試験登録日
最初に提出
2017年3月2日
QC基準を満たした最初の提出物
2017年3月16日
最初の投稿 (実際)
2017年3月23日
学習記録の更新
投稿された最後の更新 (実際)
2022年10月28日
QC基準を満たした最後の更新が送信されました
2022年10月26日
最終確認日
2022年10月1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。