Wearable for Assessing Tremor and Continuous Health in Parkinson's Disease and Essential Tremor (PD-WATCH)
2026年8月26日 更新者：Anne Bernassau、Heriot-Watt University
Wearable for Assessing Tremor and Continuous Health in Parkinson's and Essential Tremor Diseases
This prospective observational study will examine tremor and upper-limb movement in adults with Parkinson's disease or essential tremor using non-invasive wearable sensors.
Participants will attend one clinic visit and may then wear sensors at home for 3, 7, or 21 days.
Clinic assessments will be scheduled around participants' usual medication times; the study will not change or delay treatment.
Sensor data will be analysed offline for research and will not be used to make clinical decisions.
調査の概要
詳細な説明
The study will recruit up to 60 adults through NHS Lothian: 40 with Parkinson's disease and 20 with essential tremor.
During the clinic visit, participants will complete clinical assessments and movement tasks while wearing the PD-WATCH research sensor and comparator wearable sensors.
Participants allocated to home monitoring will wear the sensors during usual daily activities and complete brief medication, symptom, and activity logs.
The study will describe wearable-derived movement features, explore their relationships with clinical assessments and medication timing, and assess the feasibility and acceptability of wearable monitoring.
The study is exploratory and is not designed to evaluate diagnostic accuracy, treatment effects, or device performance.
研究の種類
観察的
入学 (推定)
60
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Gordon Duncan
- 電話番号：+44 131 537 3804
- メール：gordon.duncan2@nhs.scot
研究連絡先のバックアップ
- 名前：Anne Bernassau
- 電話番号：+44 131 451 3358
- メール：a.bernassau@hw.ac.uk
研究場所
-
-
Edinburgh
-
Edinburgh、Edinburgh、イギリス、EH4 2XU
- Clinical Research Facility, Western General Hospital, NHS Lothian
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adults with a clinical diagnosis of idiopathic Parkinson's disease or essential tremor receiving care through NHS Lothian services.
Potential participants will be identified through relevant NHS clinical pathways.
説明
Inclusion Criteria:
- Aged 18 years or older.
- Clinical diagnosis of idiopathic Parkinson's disease (Hoehn and Yahr stage I-III) or essential tremor.
- Motor or tremor symptoms confirmed on clinical assessment.
- Able to walk at least 4 metres independently, with or without a walking aid.
- Able to provide written informed consent and comply with study procedures.
- Willing and able to wear the study sensors in clinic and, where applicable, at home.
- Able to understand study information and complete study materials in English.
Exclusion Criteria:
- A recent major cardiovascular or cerebrovascular event, or another unstable condition that would make participation unsafe.
- An uncontrolled psychiatric disorder, ongoing substance misuse, active systemic cancer treatment, or another serious illness likely to interfere with participation.
- Pregnancy at enrolment.
- Active skin disease or known allergy to adhesive plaster at anticipated sensor sites.
- Dementia with Lewy Bodies, atypical, vascular, or drug-induced parkinsonism.
- Previous invasive neuromodulation or neurosurgery for a movement disorder, including deep brain stimulation.
- Current or recent participation in another interventional study that could affect safety or study outcomes.
- In the investigator's opinion, unable to complete the study procedures safely.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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 |
介入・治療 |
|---|---|
|
Parkinson's disease cohort (n=40)
Adults with idiopathic Parkinson's disease who complete clinic-based assessment and wearable monitoring, with home monitoring for 3, 7, or 21 days.
|
PD-WATCH and comparator wearable sensors are used only to collect research data.
Both cohorts continue their usual medication and clinical care; no treatment is assigned or changed by the study.
|
|
Essential Tremor cohort (n=20)
Adults with essential tremor who complete clinic-based assessment and wearable monitoring, with home monitoring for 3, 7, or 21 days.
|
PD-WATCH and comparator wearable sensors are used only to collect research data.
Both cohorts continue their usual medication and clinical care; no treatment is assigned or changed by the study.
|
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 |
|---|---|---|
|
Wearable sensor data completeness for tremor and upper-limb movement analysis
時間枠：Day 1 through completion of home monitoring, up to 22 days.
|
Percentage of participants with sufficient valid wearable sensor data to extract predefined tremor and upper-limb movement features for descriptive analysis.
This will be calculated as the number of participants with usable sensor recordings divided by the number of participants who started the relevant clinic or home-monitoring assessment, multiplied by 100.
|
Day 1 through completion of home monitoring, up to 22 days.
|
|
Completeness of paired wearable and clinical assessment data
時間枠：Day 1.
|
Percentage of participants with usable paired wearable sensor recordings and clinician-rated motor assessment data available for exploratory correlation analysis.
This will be calculated as the number of participants with both valid wearable data and relevant clinical assessment data divided by the number of participants completing the clinic visit, multiplied by 100.
|
Day 1.
|
|
Participant-rated device comfort and usability score
時間枠：Day 1 and at completion of home monitoring, up to 22 days.
|
Mean participant-rated device comfort and usability score, calculated from study questionnaire items scored from 1 to 5. A score of 1 indicates "not satisfied" and 5 indicates "very satisfied".
Higher scores indicate better comfort, usability, perceived safety, and acceptability.
Scores will be reported separately for Day 1 and for completion of home monitoring, where available.
|
Day 1 and at completion of home monitoring, up to 22 days.
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Completeness of paired home wearable and diary data
時間枠：Home monitoring period, up to 21 days.
|
Percentage of participants with sufficient paired home wearable sensor data and participant diary data available for time-aligned descriptive analysis.
This will be calculated as the number of participants with usable wearable recordings and corresponding medication, symptom, or activity diary entries divided by the number of participants who started home monitoring, multiplied by 100.
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Home monitoring period, up to 21 days.
|
|
Completeness of paired pre-dose and post-dose wearable data
時間枠：Day 1.
|
Percentage of participants with usable wearable sensor recordings at both pre-dose and post-dose clinic assessments available for within-participant descriptive comparison.
This will be calculated as the number of participants with valid wearable data at both clinic timepoints divided by the number of participants completing both clinic assessments, multiplied by 100.
|
Day 1.
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- スタディチェア：Anne Bernassau、Heriot-Watt University
- 主任研究者：Gordon Duncan、NHS Lothian
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年9月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年8月14日
QC基準を満たした最初の提出物
2026年8月21日
最初の投稿 (実際)
2026年8月26日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月31日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 26/NS/0032
- 361292 (その他の識別子：Integrated Research Application System (IRAS))
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?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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