Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
2026年8月19日 更新者：Dr. Priya Kannan、The Hong Kong Polytechnic University
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke: a Randomized Controlled Pilot Trial
Neurogenic overactive bladder (nOAB) is a common and distressing sequela following stroke, significantly impairing quality of life and imposing a substantial financial burden.
Existing pharmacological options often present adverse effects, while standard non-pharmacological treatments, such as pelvic floor muscle training (PFMT), face compliance and efficacy limitations in individuals with functional impairments.
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique capable of modulating neuronal excitability and cortical plasticity.
Targeting the supplementary motor area (SMA) via tDCS may regulate pelvic floor muscle (PFM) and detrusor activities.
However, clinical evidence evaluating tDCS as an adjuvant to PFMT for stroke survivors with nOAB is lacking.
This randomized controlled pilot trial aims to evaluate the feasibility, preliminary effectiveness, and cost-utility of active tDCS combined with PFMT compared to sham tDCS plus PFMT in stroke survivors suffering from nOAB.
調査の概要
状態
まだ募集していません
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
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：Daniel KY Zheng, PhD
- 電話番号：+852 53205956
- メール：daniel.zheng@polyu.edu.hk
研究連絡先のバックアップ
- 名前：Daniel KY Zheng, PhD
- 電話番号：+852 53205956
- メール：kangyong.zheng@connect.polyu.hk
研究場所
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Hong Kong
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Hong Kong、Hong Kong、中国、999077
- The Hong Kong Polytechnic University
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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
説明
Inclusion Criteria:
- Aged between 18-80 years with onset of stroke within one and twelve months of enrollment and having overactive bladder (OAB) symptoms;
- Experiencing moderate (scoring 6-11 points on the Overactive Bladder Symptom Score [OABSS]) to severe OAB (scoring ≥ 12 points on OABSS);
- Obtaining a Mini-Mental State Examination (MMSE) score of ≥ 24.
Exclusion Criteria:
- Presence of metallic implants in the cranium, intracardiac lines, increased intracranial pressure, cardiac pacemaker, cochlear implants, tumour, and skull abnormalities;
- Family history of epilepsy/seizures;
- Contraindications to transcranial magnetic stimulation.
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
- 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：ダブル
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：Active transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
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Participants will receive active tDCS (1.5 mA for 20 minutes; current density 0.06 mA/cm²) 3 times per week for 8 weeks.
tDCS will be conducted using two 5 x 7 cm² surface electrodes connected to a battery-powered stimulator (Neuroelectrics Instrument Controller, v 2.0).
The anodal electrode will be placed over the supplementary motor area, and the cathodal electrode over the contralateral supraorbital region.
Immediately following tDCS, participants will receive supervised, individual (1:1) PFMT for 30 minutes per session, consisting of pelvic floor contraction exercises (contracting the urethra/shortening the penis and controlling passage of gas), each held for 10 seconds and followed by 10 seconds of relaxation.
PFMT will be performed 3 times per week for 8 weeks.
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偽コンパレータ：Sham transcranial direct current stimulation (tDCS) + pelvic floor muscle training (PFMT)
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Immediately following tDCS, participants will receive supervised, individual (1:1) PFMT for 30 minutes per session, consisting of pelvic floor contraction exercises (contracting the urethra/shortening the penis and controlling passage of gas), each held for 10 seconds and followed by 10 seconds of relaxation.
PFMT will be performed 3 times per week for 8 weeks.
Participants will receive sham tDCS (active current for 30 seconds, then turned off) 3 times per week for 8 weeks.
tDCS will be conducted using two 5 x 7 cm² surface electrodes connected to a battery-powered stimulator (Neuroelectrics Instrument Controller, v 2.0).
The anodal electrode will be placed over the supplementary motor area, and the cathodal electrode over the contralateral supraorbital region.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Overactive bladder symptoms severity
時間枠：Baseline and post-intervention at 8 weeks
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Overactive bladder symptoms severity will be assessed using Overactive Bladder Symptom Score (OABSS).
The total score of OABSS ranges from 0 to 15, with a higher score indicating higher symptom severity.
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Baseline and post-intervention at 8 weeks
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment Rate
時間枠：Through study completion, an average of 1 year.
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Number of participants recruited and screened per week during the recruitment period.
The unit of measure is participants/week.
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Through study completion, an average of 1 year.
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Time to Complete Recruitment
時間枠：Through study completion, an average of 1 year.
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Total time required to recruit the full study sample.
The unit of measure is weeks.
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Through study completion, an average of 1 year.
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Retention Rate
時間枠：Baseline to 8 weeks
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Percentage of enrolled participants who complete assessments at 8 weeks post-intervention, calculated as (number completing 8-week assessment / number enrolled) × 100.
The unit of measure is %.
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Baseline to 8 weeks
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Adherence to Intervention
時間枠：Baseline to 8 weeks
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Percentage of total prescribed intervention sessions attended, calculated as (number of sessions attended / number of sessions prescribed) × 100.
The unit of measure is %.
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Baseline to 8 weeks
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Adverse Events
時間枠：Baseline to 8 weeks
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Number of participants in each group who experience adverse events, monitored throughout the intervention.
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Baseline to 8 weeks
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Detrusor Wall Thickness
時間枠：Baseline and post-intervention at 8 weeks
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Detrusor wall thickness measured using the Mindray Consona N9 ultrasound system (Sonos Medical Limited) with a convex transducer of 3-6 MHz.
An increase in detrusor wall thickness indicates detrusor overactivity.
The unit of measure is millimeter (mm).
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Baseline and post-intervention at 8 weeks
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Bladder Neck Elevation
時間枠：Baseline and post-intervention at 8 weeks
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Bladder neck elevation, a surrogate measure of pelvic floor muscle strength, will be measured using the Mindray Consona N9 ultrasound system (Sonos Medical Limited).
Greater bladder neck elevation indicates stronger pelvic floor muscle strength.
The unit of measure is millimeter (mm).
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Baseline and post-intervention at 8 weeks
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Health-Related Quality of Life
時間枠：Baseline and post-intervention at 8 weeks
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Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire.
The score ranges from -0.864 to 1.0, where 1.0 indicates full health and higher scores indicate better health-related quality of life.
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Baseline and post-intervention at 8 weeks
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Healthcare Costs
時間枠：Baseline and post-intervention at 8 weeks.
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Healthcare Costs will be collected using the Client Service Receipt Inventory (CSRI) to calculate total healthcare-related costs per participant from both healthcare provider and societal perspectives.
The unit of measure is Hong Kong Dollars (HKD).
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Baseline and post-intervention at 8 weeks.
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Incontinence-related quality of life
時間枠：Baseline and post-intervention at 8 weeks
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Incontinence-related quality of life will be assessed using the Incontinence Quality of Life Questionnaire (I-QoL).
The I-QoL score ranges from 0-100, with higher scores indicating higher quality of life.
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Baseline and post-intervention at 8 weeks
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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。
捜査官
- 主任研究者：Priya Kannan, PhD、The Hong Kong Polytechnic University
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14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2日
QC基準を満たした最初の提出物
2026年8月12日
最初の投稿 (実際)
2026年8月17日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月21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19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
- HSEARS20260727002
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
IPD プランの説明
Because the IPD will contain sensitive privacy data of the participants, it will not be suitable to be shared.
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米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
はい
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