Asymmetric Subthalamic Deep Brain Stimulation for Axial Motor Dysfunction in Parkinson's Disease
A Single-center, Randomized, Double-blinded, Double-crossover Trial of Asymmetric Subthalamic Deep Brain Stimulation for Axial Motor Dysfunction in Parkinson's Disease
調査の概要
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Ontario
-
Toronto、Ontario、カナダ、M5T 2S8
- Movement disorders Centre, Toronto Western Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
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:
- Patients with Parkinson's disease (PD) (previously diagnosed according to the UK brain bank criteria) who develop treatment-resistant postural instability gait dysfunction (PIGD) more than 6 months but less than 5 years after bilateral subthalamic nucleus deep brain stimulation (STN-DBS).
- Treatment-resistant PIGD will be defined as freezing of gait and UPDRS or MDS-UPDRS PIGD subscales of more than 6 points despite optimization of medications and bilateral STN-DBS programming.
Exclusion Criteria:
- Treatment-resistant PIGD less than 6 months or more than 5 years after STN-DBS surgery.
- PIGD responsive to optimization of medications and/or bilateral STN-DBS programming.
- Cognitive impairment or psychiatric comorbidities (including substance abuse) that would interfere with the informed consent process, study adherence or outcome assessments.
- Advanced PD or any other neurological, cardiovascular or musculoskeletal co-morbidities that would preclude or require assistance to complete the 10-meter walking test.
- Patients not able to comply with 4-week interval evaluations following their potential enrollment due to personal reasons.
- Serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically-stable on therapy, in the opinion of the site investigator, for at least 30 days prior to study entry.
- Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
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:クロスオーバー割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:Baseline STN-DBS
Maintenance of baseline bilateral STN-DBS settings.
|
|
実験的:Asymmetric STN-DBS 1
Unilateral 50% reduction of voltage (e.g.
right side)
|
Asymmetric deep brain stimulation
|
実験的:Asymmetric STN-DBS 2
Unilateral 50% reduction of voltage (e.g.
left side)
|
Asymmetric deep brain stimulation
|
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 |
---|---|---|
Change in Gait Velocity
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
As measured during the 10-meter walk test.
In this test, participants walk at their usual, regular pace over a total distance of 10 meters.
The middle 6-meters (between the 2-meter and 8-meter marks) are timed to measure gait velocity during steady-state gait.
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in Motor Function
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
As measured by the MDS-UPDRS (Movement Disorders Society Unified Parkinson's Disease Rating Scale), which is a clinical and research tool to measure symptoms and signs of Parkinson's disease. It has 4 parts: I (non-motor experiences of daily living), II (motor experiences of daily living), III (motor exam) and IV (motor complications). The MDS-UPDRS has 60 items, scored from 0-4 each. The minimum score is 0 and the maximum score is 240. The MDS-UPDRS (motor) is Part III and measures motor signs. It has 28 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 112. The MDS-UPDRS (axial motor) is composed of items 3.1 to 3.3a and 3.9 to 3.13 of Part III of the MDS-UPDRS and measures axial motor signs. It has 8 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 32. In the MDS-UPDRS total, motor and axial motor sub-scales, lower scores indicate better symptoms/signs and higher scores indicate worse symptoms/signs, respectively. |
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Axial Motor Function (1)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
As measured by the Mini-BESTest.
The Mini-BESTest is a shorter version of the BESTest (Balance Evaluation Systems Test).
It is a clinical and research tool to measure balance control.
The Mini-BESTest has 14 items, scored from 0-2 each, so the minimum score is 0 and the maximum score is 28.
Lower scores indicate worse balance control and higher scores indicate better balance control.
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Axial Motor Function (2)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
As measured by the UPDRS-PIGD sub-scale.
The UPDRS-PIGD is the Postural Instability Gait Dysfunction (PIGD) sub-scale of the Unified Parkinson's Disease Rating Scale (UPDRS).
It is a clinical and research tool to measure PIGD.
The UPDRS-PIGD has 5 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 20.
Lower scores indicate better PIGD and higher scores indicate worse PIGD.
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Axial Motor Function (3)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
As measured by the Freezing of Gait Questionnaire.
The Freezing of Gait Questionnaire is a clinical and research tool to measure freezing of gait.
It has 6 items, scored from 0-4 each, so the minimum score is 0 and the maximum score is 24.
Lower scores indicate better and higher scores indicate worse freezing of gait, respectively.
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quantitative Gait Analysis (1)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Changes in gait velocity in m/s as measured by a quantitative gait analysis system (Zeno walkway).
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quantitative Gait Analysis (2)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Changes in step length in cm (mean, right, left) as measured by a quantitative gait analysis system (Zeno walkway). Step length difference = [right - left step length] |
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quantitative Gait Analysis (3)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Step length ratio = [right step length] / [left step length] Step length symmetry = ([right - left step length] / [right + left step length]) |
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quantitative Speech Analysis (1)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Changes in pitch in Hertz (Hz) as measured by the Praat software.
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quantitative Speech Analysis (2)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Changes in loudness in decibels (dB) as measured by the Praat software.
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quantitative Speech Analysis (3)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Changes in jitter measured in percentage by the Praat software.
In this case, jitter is the percentage change in the stability of the frequency of speech tone (i.e.
speech cycle-to-cycle frequency variation)
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quantitative Speech Analysis (4)
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Changes in shimmer measured in percentage by the Praat software.
In this case, shimmer is the percentage change in the stability of the amplitude of speech tone (i.e.
speech cycle-to-cycle amplitude variation)
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Quality of Life
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
As measured by the Total Score of the 39-item Parkinson's Disease Quality of Life Questionnaire (PDQ-39).
The PDQ-39 is a clinical and research tool to measure quality of life in Parkinson's disease.
It has 39 questions, which patients score as never (0% of the time), occasionally (25% of the time), sometimes (50% of the time), often (75% of the time) or always (100% of the time).
The PDQ-39 Total Score or Summary Index is the average of the 39 questions, expressed.
The minimum score is 0% (never) and the maximum score is 100% (always).
Lower scores indicate better quality of life and higher scores indicate worse quality of life.
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Change in Select Cognitive Tasks
時間枠:Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
Left brain cognitive function: Hopkins Verbal Learning Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Phonemic Verbal Fluency (0-no max); Semantic Verbal Fluency (Animal cue) (0-no max); Letter 1-back and 2-back working memory tasks (0-100%).
Right brain cognitive function: Brief Visual Memory Test-Revised: Total recall trials 1-3 (0-36), delayed recall (0-12); Computerized landmark line bisection (-10 to 10); Spatial 1-back and 2-back working memory tasks (0-100%).
Ranges in parentheses.
Line bisection: closer to 0 is more accurate.
For the rest: higher values are better
|
Baseline and 3 to 4 weeks after switching to each of the DBS conditions (Bilateral, Asymmetric 1, Asymmetric 2)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Alfonso Fasano, MD, PhD、University of Toronto
出版物と役立つリンク
一般刊行物
- Fasano A, Herzog J, Seifert E, Stolze H, Falk D, Reese R, Volkmann J, Deuschl G. Modulation of gait coordination by subthalamic stimulation improves freezing of gait. Mov Disord. 2011 Apr;26(5):844-51. doi: 10.1002/mds.23583. Epub 2011 Mar 2.
- Lizarraga KJ, Jagid JR, Luca CC. Comparative effects of unilateral and bilateral subthalamic nucleus deep brain stimulation on gait kinematics in Parkinson's disease: a randomized, blinded study. J Neurol. 2016 Aug;263(8):1652-6. doi: 10.1007/s00415-016-8191-3. Epub 2016 Jun 8.
- Lizarraga KJ, Luca CC, De Salles A, Gorgulho A, Lang AE, Fasano A. Asymmetric neuromodulation of motor circuits in Parkinson's disease: The role of subthalamic deep brain stimulation. Surg Neurol Int. 2017 Oct 24;8:261. doi: 10.4103/sni.sni_292_17. eCollection 2017.
- Lizarraga KJ, Gnanamanogaran B, Al-Ozzi TM, Cohn M, Tomlinson G, Boutet A, Elias GJB, Germann J, Soh D, Kalia SK, Hodaie M, Munhoz RP, Marras C, Hutchison WD, Lozano AM, Lang AE, Fasano A. Lateralized Subthalamic Stimulation for Axial Dysfunction in Parkinson's Disease: A Randomized Trial. Mov Disord. 2022 May;37(5):1079-1087. doi: 10.1002/mds.28953. Epub 2022 Feb 13.
研究記録日
主要日程の研究
研究開始 (実際)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
本研究に関する用語
キーワード
その他の研究ID番号
- 17-5785
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- 研究プロトコル
- 統計分析計画 (SAP)
- インフォームド コンセント フォーム (ICF)
- 臨床試験報告書(CSR)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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
Asymmetric STN-DBSの臨床試験
-
Xuanwu Hospital, BeijingPeking University; Beijing Tiantan Hospital; Qilu Hospital of Shandong University; Beijing Sanbo...まだ募集していません
-
University of FloridaNational Institute of Neurological Disorders and Stroke (NINDS)完了
-
Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS)募集
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Istituto Neurologico Nazionale IRCCS Casimiro Mondino, Pavia, Italy完了パーキンソン病
-
St. Joseph's Hospital and Medical Center, Phoenix終了しました
-
Tsinghua UniversityBeijing Tsinghua Changgeng Hospital募集