BION Treatment of Knee Osteoarthritis
BION Implantable Microstimulator System
調査の概要
詳細な説明
研究の種類
段階
- フェーズ 1
連絡先と場所
研究場所
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California
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Los Angeles、California、アメリカ、90033
- USC University Hospital
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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
説明
Inclusion Criteria:
- Subject presents with osteoarthritis of the knee with severity defined as Kellgren-Lawrence grade 3-4.
- Subject is between 18 and 75 years old.
- Attending physician considers the subject in general good health (other than knee joint osteoarthritis).
- Subject is mentally capable of understanding the goals and the application of therapy.
- Subject is able to apply the therapy (with or without help) in the home setting.
- Subject is willing and capable of giving informed consent.
- Subject is willing and capable of traveling to testing center at the schedule described above and detailed in Table 2.
Exclusion Criteria:
- Subject is pregnant, nursing, or planning to become pregnant in the next 12 months.
- Subject has an electronic implant (e.g. cardiac pacemaker, etc.).
- Subject has metallic implant (e.g. plates, hip joints) in the buttock or upper leg.
- Subject has a history of falling.
- Subject has medical conditions other than OA affecting the legs that could affect treatment or mobility.
- Subject is 40% or more above the ideal weight recommended by Metropolitan Life.
- Subject has cancer.
- Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention which would affect lower extremity mobility.
- Subject has bilateral knee osteoarthritis.
- Subject is taking pain medications with dosage not stable for one month.
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- 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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実験的:BION "twitch" stimulation
The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation.
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They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises. |
実験的:BION tetanic-frequency stimulation
The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions.
|
They will be divided into three groups. Two groups of experimental subjects will receive stimulation using BIONs. The first group will have a stimulation paradigm like that used in a previous feasibility study that preceded the proposed trial, using low-frequency (1-5 PPS) "twitch" stimulation. The second group will have a stimulation paradigm in which tetanic-frequency stimulation (25-50 PPS) is used to produce fused muscle contractions. A third group of experimental subjects will have a standardized program of voluntary exercise. In Groups 1 and 2, the femoral nerve will be stimulated electrically according to the assigned protocol during the 12 week experimental period after implantation of the devices. Individuals assigned to Group 3, receiving conventional exercise therapy for 12 weeks, will be allowed to receive BIONs at the end of the trial, providing they request BION therapy and they have been at least minimally compliant with the exercises. |
介入なし:Standardized program
A third group of experimental subjects will have a standardized program of voluntary exercise.
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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 |
時間枠 |
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quadriceps isometric strength
時間枠:pre-exercise, 4w, 8w, 12w
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pre-exercise, 4w, 8w, 12w
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二次結果の測定
結果測定 |
時間枠 |
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Gait velocity Gait endurance Pain WOMAC
時間枠:pre-exercise, 8w, 12w
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pre-exercise, 8w, 12w
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協力者と研究者
捜査官
- 主任研究者:Lucinda Baker, Ph.D、University of Southern California
出版物と役立つリンク
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。
BIONの臨床試験
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Chinook Therapeutics, Inc.積極的、募集していない
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Chinook Therapeutics, Inc.募集