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Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity 第IV相・フェーズ4 60

募集準備中
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治験番号 NCT07440173 は 治療 の研究で、脳卒中後の痙性 に関するものです。この 第IV相・フェーズ4 介入研究 臨床試験 は現在 募集準備中 で、2026年5月1日 に開始予定です。60 名の参加者 の募集が計画されています。この試験は アシュート大学 によって主導され、2027年7月15日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年2月27日 です。
概要
This study aims to evaluate the efficacy of a combined treatment approach for post-stroke upper limb spasticity using phenol neurolysis and botulinum toxin (BoNT). Spasticity is a common post-stroke complication that leads to muscle stiffness and significantly hinders functional recovery. While botulinum toxin is the standard treatment, its high cost often limits its application, particularly for large proximal muscl...もっと見る
詳細説明
Background and Rationale:

Post-stroke spasticity is a manifestation of Upper Motor Neuron Syndrome, characterized by reduced cortical inhibition and maladaptive plastic changes in both the ipsilesional and contralesional hemispheres. While Botulinum Toxin Type A (BoNT-A) provides focal chemodenervation, its effect on central neurophysiology is an area of active research. This study evaluates a hybrid approach-proxim...

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公式タイトル

Combined Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Upper-Limb Spasticity After Stroke: A Randomized Trial

疾患名
脳卒中後の痙性
刊行物
この臨床試験について発表された科学記事と研究論文：
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その他の研究識別子
  • NuroRehabSpasticity
NCT番号
NCT07440173
開始日
2026-05-01
最終更新日
2026-02-27
終了予定日
2027-07-15
目標参加者数
60
試験の種類
介入研究
治験の相・段階
第IV相・フェーズ4
状況
募集準備中
キーワード
Phenol Neurolysis
Botulinum Toxin Type A
Transcranial Magnetic Stimulation (TMS)
Cortical Excitability
Upper Limb Rehabilitation
Ultrasound-Guided Injection
主目的
治療
割付方法
無作為化
介入モデル
並行割当
盲検化
単盲検
群（アーム）／介入
参加グループ/群介入/治療法
実験的Hybrid Neuro-Chemodenervation (Phenol + BoNT-A)
Participants in this arm will receive a combined treatment approach. Phenol neurolysis (5% aqueous solution) will be administered under ultrasound guidance to the proximal nerves (specifically the pectoralis nerves for shoulder spasticity and the musculocutaneous nerve for elbow flexor spasticity). Concurrently, Botulinum Toxin Type A (BoNT-A) will be injected into the distal forearm flexor muscles (e.g., Flexor Carp...もっと見る
Phenol Neurolysis
A chemical neurolysis procedure using a 5% aqueous phenol solution. Under real-time ultrasound (US) guidance, the needle is advanced until it is adjacent to the target nerve trunk. The phenol is then injected to induce protein denaturation and axonal degeneration (Wallerian degeneration), effectively interrupting the spastic reflex arc. Targets: The pectoralis nerves (to address shoulder adduction and internal rotat...もっと見る
Botulinum Toxin - A injections
A focal chemodenervation procedure using Botulinum Toxin Type A. The toxin is reconstituted with 0.9% sterile saline. Using ultrasound guidance, the medication is injected directly into the motor points of the hypertonic muscles. The toxin acts by inhibiting the release of acetylcholine at the neuromuscular junction, resulting in localized muscle relaxation. Targets (Experimental Group): Distal muscles only (e.g., F...もっと見る
実薬対照薬Standard Chemodenervation (BoNT-A Alone)
Participants in this arm will receive the standard-of-care treatment consisting of Botulinum Toxin Type A (BoNT-A) injections alone. The toxin will be administered under ultrasound guidance to all clinically indicated upper limb muscles, including both proximal (e.g., Pectoralis major, Biceps brachii) and distal muscle groups (e.g., forearm flexors), following standard clinical dosing guidelines.
Botulinum Toxin - A injections
A focal chemodenervation procedure using Botulinum Toxin Type A. The toxin is reconstituted with 0.9% sterile saline. Using ultrasound guidance, the medication is injected directly into the motor points of the hypertonic muscles. The toxin acts by inhibiting the release of acetylcholine at the neuromuscular junction, resulting in localized muscle relaxation. Targets (Experimental Group): Distal muscles only (e.g., F...もっと見る
主要評価項目
評価指標指標の説明時間枠
Change from Baseline in the Modified Ashworth Scale (MAS) at 4 and 12 weeks.
The MAS is used to assess muscle spasticity on a scale from 0 to 4. We will calculate the mean change in scores from baseline to each follow-up point. Lower scores indicate a reduction in muscle tone.
Baseline, 4 weeks, and 12 weeks.
副次評価項目
評価指標指標の説明時間枠
Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (FMA-UE).
A stroke-specific scale to evaluate motor recovery. Scores range from 0 to 66, with higher scores indicating better motor function.
Baseline, 4 weeks, and 12 weeks.
Goal Attainment Scale (GAS).
Evaluates the achievement of individual functional goals set at baseline.
4 weeks and 12 weeks.
Change from Baseline in Resting Motor Threshold (RMT) of both hemispheres.
Change from Baseline in Resting Motor Threshold (RMT) of both hemispheres measured using single-pulse Transcranial Magnetic Stimulation (TMS). Resting Motor Threshold will be assessed using single-pulse transcranial magnetic stimulation delivered over the primary motor cortex (M1) with a figure-of-eight coil. Surface electromyography (EMG) will record motor-evoked potentials (MEPs) from the contralateral first dorsal interosseous (FDI) muscle. RMT is defined as the minimum stimulator intensity (% of maximum stimulator output) required to elicit MEPs ≥50 μV in at least 5 out of 10 consecutive trials. RMT will be measured separately for the ipsilesional and contralesional hemispheres. Values are expressed as a percentage of maximum stimulator output (% MSO). Lower RMT values indicate increased corticospinal excitability. Assessments will occur at baseline, 4 weeks, and 12 weeks.
Baseline, 4 weeks, and 12 weeks.
Change from Baseline in Cortical Silent Period (CSP) duration.
Change from Baseline in Cortical Silent Period (CSP) duration measured using transcranial magnetic stimulation (TMS). CSP duration will be assessed using single-pulse TMS delivered over the primary motor cortex during voluntary contraction (approximately 20% of maximal voluntary contraction) of the contralateral first dorsal interosseous muscle. CSP is defined as the duration (milliseconds) from the onset of the motor-evoked potential to the return of continuous EMG activity. CSP duration will be recorded for both hemispheres. Values are expressed in milliseconds (ms). Longer CSP duration reflects increased cortical inhibition.
Baseline, 4 weeks, and 12 weeks.
Total Dose of Botulinum Toxin Type A (BoNT-A) administered.
Comparison of the total units of BoNT-A used between the Hybrid group and the Standard group.
Day 0 (at time of injection).
参加アシスタント
適格基準

対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
  • Adults aged 18 to 70 years.
    • Diagnosis: Documented Ischemic or Hemorrhagic stroke (with a duration of at least 6 months post-stroke to ensure a chronic, stable phase).
    • Spasticity Severity: A score of 2 on the Modified Ashworth Scale (MAS) in at least one proximal muscle group (Shoulder adductors or Elbow flexors).
    • Functional Status: Evidence of upper limb motor impairment but with enough stability to participate in follow-up.
    • Cognitive Ability: Ability to understand and follow instructions (Mini-Mental State Examination score typically 24) to ensure cooperation during TMS and functional testing.
    • Consent: Signed informed consent provided by the patient or a legal guardian.

  • Fixed Contractures: Any permanent joint deformity or fixed contracture in the target limb that would prevent range of motion improvement.
    • Prior Treatment: Received Botulinum Toxin or phenol injections in the affected limb within the last 6 months.
    • TMS Contraindications: History of seizures.
    • Presence of metallic implants in the head or neck (e.g., clips, shunts).
    • Cardiac pacemakers or implanted medication pumps.
    • Local Factors:Skin infection or inflammation at the planned injection sites.
    • Medical Co-morbidities: Significant peripheral nerve disease (other than the stroke-related upper motor neuron lesion) or severe psychiatric disorders.
    • Phenol Sensitivity: Known hypersensitivity to phenol or its derivatives.
Assiut University logoアシュート大学
責任者
Mohammad Ahmad Mohammad Korayem, 主任研究者, Assistant lecturer, Assiut University
試験中央連絡先
連絡先: Mohammad Ahmad Korayem, Master's degree, +201021478054, [email protected]
位置情報がありません。