- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02235792
High Frequency Oscillations in Neurologic Disease
Chronically-recorded Deep Brain Nuclei/Hippocampal High Frequency Oscillations (HFOs) as Biomarkers of Neurologic Disease.
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Mayo Clinic in Rochester
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
Medically-refractory neurologic disease amenable to therapy with deep brain stimulation including:
Idiopathic Parkinson disease with motor fluctuation, dyskinesia, and/or medically refractory tremor despite optimal medical management by a movement disorders neurologist.
OR
Unilateral or bilateral mesial temporal lobe (hippocampal) epilepsy with complex partial, and/or secondarily generalized seizures, that is:
- confirmed through a combination of interictal scalp EEG, ictal scalp EEG under video monitoring, ictal SPECT scanning, and/or invasive EEG monitoring
- disabling seizure counts >2 per month documented over a 3 month period
- refractory to at least three antiepileptic drugs given at clinically appropriate maintenance doses resulting in therapeutic plasma levels (in cases where such levels have been established for that particular drug. Drug failures because of side- effects will not be counted toward this total.
- determined to have mesial temporal lobe epilepsy that is not amenable to resective surgery according to consensus opinion among epileptologists on our institution's multidisciplinary Epilepsy Surgery Committee
- Mayo Clinic Deep Brain Stimulation Committee approval for bilateral deep brain stimulation therapy obtained on routine clinical grounds and without reference to this protocol.
- Age 18 to 75.
- Ability and willingness to provide informed consent and participate in the study protocol.
Exclusion criteria:
- Diagnoses other than those included in #1 above.
- Comorbid nonepileptic behavioral events or psychogenic movement disorder.
- Medical contraindications to DBS surgery.
- Psychiatric comorbidities not under stable medical therapy.
- Neurodegenerative dementia (cognitive dysfunction resulting from frequent seizure activity will not be an exclusion criteria).
- Implanted electronically active medical device with the potential to interfere with intracranial recordings (ex. pacemaker, automatic implantable cardioverter defibrillator (AICD), active vagal nerve stimulator).
- Pregnancy; women of child-bearing potential will be required to commit to using an effective method of contraception during the entire duration of the trial. If a subject becomes pregnant despite these precautions, she will be required to report that to our center within two weeks at which point explantation of the experimental device would be an option.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Deep Brain Stimulation 37604 Activa PC+S
All subjects will undergo DBS using the 37604 Activa PC+S device (single arm study).
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The model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Degree of correlation of recorded neural signatures with disease severity as determined by regression analysis
기간: 26 weeks post deep brain stimulator implantation
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Regression analysis will be performed using the measures of clinical disease severity as the independent variables and the various HFO measurement conditions/parameters as dependent variables. HFO parameters to be analyzed will include: 1) total power within each recorded band and 2) frequency distribution as defined by the ratio of power within the higher HFO frequency band versus the lower HFO frequency band. Clinical disease severity will be determined by: 1) Unified Parkinson's Disease Rating Scale (UPDRS III) score in each of the various conditions for Parkinson Disease (PD) subjects, 2) motor diaries linked with each visit for PD subjects, and 3) seizure counts from the 4 weeks of seizure diary preceding each visit for epilepsy subjects. (Note: UPDRS is a rating scale used to follow the longitudinal course of Parkinson's disease. Part III is a clinician-scored monitored motor evaluation.) |
26 weeks post deep brain stimulator implantation
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Bryan Klassen, MD, Mayo Clinic
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 13-002360
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. .
Activa PC+S에 대한 임상 시험
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University Hospital, BordeauxAPTES 100 rue boileau 69006 Lyon완전한
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University Hospital TuebingenMedtronic완전한
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Baylor College of MedicineNational Institute of Neurological Disorders and Stroke (NINDS); University of Pittsburgh; Brown University 그리고 다른 협력자들모집하지 않고 적극적으로