Follow Up Study for Treatment of Parkinson's Disease With Deep Brain Stimulation (CSP#468F)
CSP #468F - Long Term Study of Deep Brain Stimulation for Parkinson's Disease: A Longitudinal Follow-Up Study of the VA/NINDS CSP #468 Cohort
調査の概要
状態
条件
詳細な説明
Parkinson's disease (PD), the second most prevalent neurodegenerative disease (after Alzheimer's disease), affects more than a million Americans and is a common condition in the Veteran population. Although there is currently no cure for the disease, many of the symptoms of the disease can be effectively managed with medications and with deep brain stimulation (DBS). This study seeks to build upon the original CSP#468 protocol by providing an efficient long-term follow-up study. The objectives of this study are to:
determine whether the motor benefits of deep brain stimulation persist beyond two years of follow-up in patients with Parkinson's disease; determine whether the target of stimulation (GPi vs. STN) affects the durability of long-term motor improvement; define the impact of DBS on long-term function and quality of life in patients with Parkinson's disease; identify clinical features that predict favorable or unfavorable long-term outcome; and describe the long-term performance of the DBS devices, including device durability, device explanation rate, neurostimulator replacement frequency, and changes in stimulation parameters to achieve optimum symptom control.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
California
-
Los Angeles、California、アメリカ、90095
- UCLA-University of California at Los Angeles(904)
-
San Francisco、California、アメリカ、94121
- San Francisco VA Medical Center, San Francisco, CA
-
San Francisco、California、アメリカ、94115
- San Francisco-University of California at San Francisco(905)
-
West Los Angeles、California、アメリカ、90073
- VA Greater Los Angeles Healthcare System, West LA
-
-
Oregon
-
Portland、Oregon、アメリカ、97201
- VA Medical Center, Portland
-
Portland、Oregon、アメリカ、97239
- Portland-Oregon Health & science University(906)
-
-
Pennsylvania
-
Philadelphia、Pennsylvania、アメリカ、19104
- VA Medical Center, Philadelphia
-
Philadelphia、Pennsylvania、アメリカ、19107
- Philadelphia-University of Pennsylvania Health System(901)
-
-
Texas
-
Houston、Texas、アメリカ、77030
- Michael E. DeBakey VA Medical Center (152)
-
Houston、Texas、アメリカ、77030
- Houston-Methodist Hospital(903)
-
-
Virginia
-
Richmond、Virginia、アメリカ、23249
- Hunter Holmes McGuire VA Medical Center
-
Richmond、Virginia、アメリカ、23298
- Richmond-Medical college of Virginia(902)
-
-
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
説明
Inclusion Criteria:
- Participant in CSP#468
- Available and willing to be followed-up according to study protocol
Exclusion Criteria:
- DBS device explanted or permanently turned off without anticipated resumption of DBS therapy.
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
コホートと介入
グループ/コホート |
---|
Globus Pallidus interna Group
Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
|
Subthalamic Nucleus Group
Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
|
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 |
---|---|---|
Off-medication/On-stimulation Motor Function Score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III)
時間枠:The change score of UPDRS Part III from baseline to 9 years post surgery
|
The primary outcome measure for the comparison of GPi deep brain stimulation (DBS) to STN DBS is the motor function score of the Unified Parkinson's Disease Rating Scale (UPDRS Part III) measured while the patient is off medications and on stimulation at follow-up visits post surgery.
UPDRS Part III has 14 items assessing motor skills including facial expression and speech, tremors, rigidity, posture, gait, and bradykinesia.
Left and right sides (arms, legs, and hands) are assessed separately for seven of the functions.
A summary score ranging from 0 to 108 is generated by adding the 14 specific motor function responses.
The motor function (UPDRS part III) assessments are done by turning on the stimulation with and without taking PD medications (on/off) at each in-person visit.
The higher the value, the worse the outcome.
|
The change score of UPDRS Part III from baseline to 9 years post surgery
|
協力者と研究者
捜査官
- スタディチェア:William J. Marks, MD、San Francisco VA Medical Center, San Francisco, CA
研究記録日
主要日程の研究
研究開始
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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。
パーキンソン病の臨床試験
-
Adelphi Values LLCBlueprint Medicines Corporation完了肥満細胞性白血病 (MCL) | 攻撃的な全身性肥満細胞症 (ASM) | SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD) | くすぶり全身性肥満細胞症 (SSM) | 無痛性全身性肥満細胞症 (ISM) ISM サブグループが完全に募集されましたアメリカ