Electrophysiological Recordings of Deep Brain Stimulation in the Basal Ganglia (DBSMER)
2022년 10월 26일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
34
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Arizona
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Phoenix, Arizona, 미국, 85013
- St. Joseph's Hospital and Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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다른: 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).
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Neural Recordings
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Francisco A Ponce, MD, Barrow Brain and Spine physician with SJHMC privileges
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2016년 2월 1일
기본 완료 (실제)
2022년 3월 1일
연구 완료 (실제)
2022년 3월 1일
연구 등록 날짜
최초 제출
2017년 3월 2일
QC 기준을 충족하는 최초 제출
2017년 3월 16일
처음 게시됨 (실제)
2017년 3월 23일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 10월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 10월 26일
마지막으로 확인됨
2022년 10월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .