[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626787":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":41,"collaborators":26,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":26,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":26,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":26},{"fullName":5,"class":6},"Assiut University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Hybrid Neuro-Chemodenervation (Phenol + BoNT-A)","EXPERIMENTAL","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 Carpi Radialis, Flexor Carpi Ulnaris, and Flexor Digitorum Profundus\u002FSublimis) to address wrist and finger spasticity.",[13,14],"Procedure: phenol neurolysis","Procedure: Botulinum Toxin - A injections",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard Chemodenervation (BoNT-A Alone)","ACTIVE_COMPARATOR","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.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","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.\n\nTargets: The pectoralis nerves (to address shoulder adduction and internal rotation) and the musculocutaneous nerve (to address elbow flexion).\n\nVolume: Typically 1-3 mL per nerve site, adjusted based on patient anatomy and US visualization of the spread.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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.\n\nTargets (Experimental Group): Distal muscles only (e.g., Flexor Carpi Radialis, Flexor Digitorum Superficialis\u002FProfundus).\n\nTargets (Comparator Group): Both proximal (Biceps, Pectoralis) and distal muscles.\n\nDosing: Total dose per muscle is determined based on the Modified Ashworth Scale (MAS) score and muscle volume, following international consensus guidelines.",[9,16],[32],{"name":33,"affiliation":5,"role":34},"Mohammad Korayem, Master's degree","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Mohammad Ahmad Korayem, Master's degree","CONTACT","+201021478054","Mohammadkorayem@aun.edu.eg",{"type":34,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Mohammad Ahmad Mohammad Korayem","Assistant lecturer","100626787","phase-4-phenol-and-botulinum-toxin-vs-botulinum-toxin-alone-for-post-stroke-upper-limb-spasticity-100626787",false,"NCT07440173","Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity","Combined Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Upper-Limb Spasticity After Stroke: A Randomized Trial","* Inclusion criteria :\n\n  * Adults aged 18 to 70 years.\n  * Diagnosis: Documented Ischemic or Hemorrhagic stroke (with a duration of at least 6 months post-stroke to ensure a chronic, stable phase).\n  * Spasticity Severity: A score of 2 on the Modified Ashworth Scale (MAS) in at least one proximal muscle group (Shoulder adductors or Elbow flexors).\n  * Functional Status: Evidence of upper limb motor impairment but with enough stability to participate in follow-up.\n  * Cognitive Ability: Ability to understand and follow instructions (Mini-Mental State Examination score typically 24) to ensure cooperation during TMS and functional testing.\n  * Consent: Signed informed consent provided by the patient or a legal guardian.\n* Exclusion Criteria :\n\n  * Fixed Contractures: Any permanent joint deformity or fixed contracture in the target limb that would prevent range of motion improvement.\n  * Prior Treatment: Received Botulinum Toxin or phenol injections in the affected limb within the last 6 months.\n  * TMS Contraindications: History of seizures.\n  * Presence of metallic implants in the head or neck (e.g., clips, shunts).\n  * Cardiac pacemakers or implanted medication pumps.\n  * Local Factors:Skin infection or inflammation at the planned injection sites.\n  * Medical Co-morbidities: Significant peripheral nerve disease (other than the stroke-related upper motor neuron lesion) or severe psychiatric disorders.\n  * Phenol Sensitivity: Known hypersensitivity to phenol or its derivatives.","ALL","18 Years","70 Years",{"count":55,"type":56},60,"ESTIMATED","INTERVENTIONAL",[59],"PHASE4","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 muscles.\n\nThe researchers will compare two treatment strategies in 60 adult stroke survivors:\n\nGroup A (Combined Therapy): Patients will receive ultrasound-guided phenol neurolysis for the proximal nerves (pectoralis and musculocutaneous nerves) and botulinum toxin for the distal forearm flexors.\n\nGroup B (Standard Care): Patients will receive botulinum toxin alone for all affected muscles in the upper limb.\n\nAll procedures will be performed under ultrasound guidance to ensure anatomical precision. The study will also utilize Transcranial Magnetic Stimulation (TMS) to assess changes in cortical excitability (RMT, MEPs, and cortical silent period). The primary goal is to determine if this combined approach effectively reduces muscle stiffness (measured by the Modified Ashworth Scale) while potentially reducing the total dose of botulinum toxin required per patient.",[62],"Spasticity as Sequela of Stroke",[64,65,66,67,68,69],"Phenol Neurolysis","Botulinum Toxin Type A","Transcranial Magnetic Stimulation (TMS)","Cortical Excitability","Upper Limb Rehabilitation","Ultrasound-Guided Injection","NOT_YET_RECRUITING","2026-02-25",{"date":73,"type":74},"2026-02-27","ACTUAL",{"date":76,"type":56},"2026-05-01",{"date":78,"type":56},"2027-07-15",{"name":5,"class":6}]