Spasticity as Sequela of StrokePhase 4NCT07440173
Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Post-Stroke Upper-Limb Spasticity
A Phase 4 study testing phenol neurolysis and Botulinum Toxin - A injections in people with Spasticity as Sequela of Stroke, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spasticity as Sequela of Stroke
- What is being tested?
- phenol neurolysis and Botulinum Toxin - A injections
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 15 Jul 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Combined Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Upper-Limb Spasticity After Stroke: A Randomized Trial
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.
The researchers will compare two treatment strategies in 60 adult stroke survivors:
Read more
Group 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.
Group B (Standard Care): Patients will receive botulinum toxin alone for all affected muscles in the upper limb.
All 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.
Read the detailed description
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-proximal Phenol neurolysis combined with distal BoNT-A-compared to standard BoNT-A alone. By utilizing Transcranial Magnetic Stimulation (TMS), we aim to investigate how reducing peripheral spasticity influences central motor excitability and interhemispheric inhibition.
Methodology and Procedures:
Participants (n=60) will be randomized 1:1 into:
Group A (Hybrid): Ultrasound-guided Phenol neurolysis (5% aqueous) of the pectoralis and musculocutaneous nerves + distal BoNT-A.
Group B (Standard): Ultrasound-guided BoNT-A for all affected upper limb muscles.
Bilateral TMS Assessment \& Rationale:
Single-pulse TMS will be performed on both the ipsilesional and contralesional hemispheres to evaluate the entire motor network.
Ipsilesional Assessment: To measure corticospinal integrity via Resting Motor Threshold (RMT) and Motor Evoked Potential (MEP) amplitude.
Contralesional Assessment: To evaluate compensatory over-activity or maladaptive plasticity.
Rationale: the investigators hypothesize that effective reduction of spasticity via the hybrid approach will lead to a reduction in the Cortical Silent Period (CSP) and a shift toward normalized interhemispheric balance, potentially reflecting decreased "noise" from the spastic periphery to the cortex. If the ipsilesional MEP is absent, the contralesional hemisphere's excitability will serve as the primary neurophysiological marker.
Assessment Time Points:
All participants will undergo a comprehensive battery of assessments (Clinical, Functional, and Neurophysiological) at three specific intervals:
T0 (Baseline): prior to injection. T1 (Early Follow-up): 4 weeks post-injection (to capture peak BoNT-A and Phenol effect).
T2 (Late Follow-up): 12 weeks post-injection (to assess the sustainability of the clinical effect and central plastic changes).
Functional \& Clinical Outcomes:
Clinical response is measured via the Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS). Functional recovery is assessed through the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Goal Attainment Scale (GAS).
- Conditions
- Spasticity as Sequela of Stroke
- Being tested
- phenol neurolysis, Botulinum Toxin - A injections
- Keywords
- Phenol Neurolysis, Botulinum Toxin Type A, Transcranial Magnetic Stimulation (TMS), Cortical Excitability, Upper Limb Rehabilitation, Ultrasound-Guided Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phenol neurolysisProcedure or surgery
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 rotation) and the musculocutaneous nerve (to address elbow flexion).
Volume: Typically 1-3 mL per nerve site, adjusted based on patient anatomy and US visualization of the spread.
Botulinum Toxin - A injectionsProcedure or surgery
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., Flexor Carpi Radialis, Flexor Digitorum Superficialis/Profundus).
Targets (Comparator Group): Both proximal (Biceps, Pectoralis) and distal muscles.
Dosing: Total dose per muscle is determined based on the Modified Ashworth Scale (MAS) score and muscle volume, following international consensus guidelines.
| Study group | Role | What they receive |
|---|---|---|
| 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/Sublimis) to address wrist and finger spasticity. Receives: Procedure: phenol neurolysis; Procedure: Botulinum Toxin - A injections |
| 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. Receives: Procedure: Botulinum Toxin - A injections |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks, and 12 weeks.
Secondary outcomes (5)
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.
Measured: Baseline, 4 weeks, and 12 weeks.
Goal Attainment Scale (GAS).
Evaluates the achievement of individual functional goals set at baseline.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 0 (at time of injection).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 May 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion15 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spasticity as Sequela of StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A prospective, randomized, parallel-group, assessor-blinded controlled trial. A total of 60 participants will be recruited and randomized using a computer-generated randomization sequence into two equal groups (n=30 each). Group A (Experimental): Participants receive a combination of ultrasound-guided phenol neurolysis for proximal upper limb spasticity and Botulinum Toxin Type A (BoNT-A) for distal muscle spasticity. Group B (Active Comparator): Participants receive ultrasound-guided BoNT-A injections for all affected upper limb muscles (both proximal and distal). Clinical, functional, and neurophysiological (TMS) assessments are conducted at baseline, 4 weeks, and 12 weeks post-intervention. To ensure scientific rigor, the clinical and TMS assessments will be performed by a blinded investigator who is unaware of the group allocation.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ahmad Mohammad Korayem, Assiut University
- Investigators
- Mohammad Korayem, Master's degree, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07440173
- Sponsor's protocol ID
- NuroRehabSpasticity
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made publicly available to protect the privacy and confidentiality of the participants, in accordance with the ethical guidelines of the Assiut University Hospital Institutional Review Board. Furthermore, the data is being utilized for a Doctoral (PhD) thesis. Summary results and aggregated data will be shared through peer-reviewed publications and the final thesis dissertation upon completion of the study.
Publications
Anwar F, Ramanathan S. Combined Botulinum Toxin Injections and Phenol Nerve / Motor Point Blocks to Manage Multifocal Spasticity in Adults. British Journal of Medical Practitioners. March 2017;10(1):a1002.
Murase N, Duque J, Mazzocchio R, Cohen LG. Influence of interhemispheric interactions on motor function in chronic stroke. Ann Neurol. 2004 Mar;55(3):400-9. doi: 10.1002/ana.10848.
PubMed 14991818Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
PubMed 25797650Gonnade N, Lokhande V, Ajij M, Gaur A, Shukla K. Phenol Versus Botulinum Toxin A Injection in Ambulatory Cerebral Palsy Spastic Diplegia: A Comparative Study. J Pediatr Neurosci. 2017 Oct-Dec;12(4):338-343. doi: 10.4103/jpn.JPN_123_17.
PubMed 29675072Wissel J, Ward AB, Erztgaard P, Bensmail D, Hecht MJ, Lejeune TM, Schnider P, Altavista MC, Cavazza S, Deltombe T, Duarte E, Geurts AC, Gracies JM, Haboubi NH, Juan FJ, Kasch H, Katterer C, Kirazli Y, Manganotti P, Parman Y, Paternostro-Sluga T, Petropoulou K, Prempeh R, Rousseaux M, Slawek J, Tieranta N. European consensus table on the use of botulinum toxin type A in adult spasticity. J Rehabil Med. 2009 Jan;41(1):13-25. doi: 10.2340/16501977-0303.
PubMed 19197564
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Phenol and Botulinum Toxin vs Botulinum Toxin Alone for Upper-Limb Spasticity After Stroke: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07440173
- Acronym / sponsor ID
- NuroRehabSpasticity
- Conditions
- Spasticity as Sequela of Stroke
- Keywords
- Phenol Neurolysis, Botulinum Toxin Type A, Transcranial Magnetic Stimulation (TMS), Cortical Excitability, Upper Limb Rehabilitation, Ultrasound-Guided Injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 15 Jul 2027 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The researchers will compare two treatment strategies in 60 adult stroke survivors:
Group 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.
Group B (Standard Care): Patients will receive botulinum toxin alone for all affected muscles in the upper limb.
All 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.
Detailed description
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-proximal Phenol neurolysis combined with distal BoNT-A-compared to standard BoNT-A alone. By utilizing Transcranial Magnetic Stimulation (TMS), we aim to investigate how reducing peripheral spasticity influences central motor excitability and interhemispheric inhibition.
Methodology and Procedures:
Participants (n=60) will be randomized 1:1 into:
Group A (Hybrid): Ultrasound-guided Phenol neurolysis (5% aqueous) of the pectoralis and musculocutaneous nerves + distal BoNT-A.
Group B (Standard): Ultrasound-guided BoNT-A for all affected upper limb muscles.
Bilateral TMS Assessment \& Rationale:
Single-pulse TMS will be performed on both the ipsilesional and contralesional hemispheres to evaluate the entire motor network.
Ipsilesional Assessment: To measure corticospinal integrity via Resting Motor Threshold (RMT) and Motor Evoked Potential (MEP) amplitude.
Contralesional Assessment: To evaluate compensatory over-activity or maladaptive plasticity.
Rationale: the investigators hypothesize that effective reduction of spasticity via the hybrid approach will lead to a reduction in the Cortical Silent Period (CSP) and a shift toward normalized interhemispheric balance, potentially reflecting decreased "noise" from the spastic periphery to the cortex. If the ipsilesional MEP is absent, the contralesional hemisphere's excitability will serve as the primary neurophysiological marker.
Assessment Time Points:
All participants will undergo a comprehensive battery of assessments (Clinical, Functional, and Neurophysiological) at three specific intervals:
T0 (Baseline): prior to injection. T1 (Early Follow-up): 4 weeks post-injection (to capture peak BoNT-A and Phenol effect).
T2 (Late Follow-up): 12 weeks post-injection (to assess the sustainability of the clinical effect and central plastic changes).
Functional \& Clinical Outcomes:
Clinical response is measured via the Modified Ashworth Scale (MAS) and Modified Tardieu Scale (MTS). Functional recovery is assessed through the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Goal Attainment Scale (GAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective, randomized, parallel-group, assessor-blinded controlled trial. A total of 60 participants will be recruited and randomized using a computer-generated randomization sequence into two equal groups (n=30 each). Group A (Experimental): Participants receive a combination of ultrasound-guided phenol neurolysis for proximal upper limb spasticity and Botulinum Toxin Type A (BoNT-A) for distal muscle spasticity. Group B (Active Comparator): Participants receive ultrasound-guided BoNT-A injections for all affected upper limb muscles (both proximal and distal). Clinical, functional, and neurophysiological (TMS) assessments are conducted at baseline, 4 weeks, and 12 weeks post-intervention. To ensure scientific rigor, the clinical and TMS assessments will be performed by a blinded investigator who is unaware of the group allocation.
| Arm | Type | Receives |
|---|---|---|
| Hybrid Neuro-Chemodenervation (Phenol + BoNT-A) | Experimental | Procedure: phenol neurolysis, Procedure: Botulinum Toxin - A injectionsParticipants 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/Sublimis) to address wrist and finger spasticity. |
| Standard Chemodenervation (BoNT-A Alone) | Active comparator | Procedure: Botulinum Toxin - A injectionsParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
Key exclusion criteria (8 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phenol neurolysisA 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 rotation) and the musculocutaneous nerve (to address elbow flexion). Volume: Typically 1-3 mL per nerve site, adjusted based on patient anatomy and US visualization of the spread. | Procedure or surgery | Hybrid Neuro-Chemodenervation (Phenol + BoNT-A) |
| Botulinum Toxin - A injectionsA 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., Flexor Carpi Radialis, Flexor Digitorum Superficialis/Profundus). Targets (Comparator Group): Both proximal (Biceps, Pectoralis) and distal muscles. Dosing: Total dose per muscle is determined based on the Modified Ashworth Scale (MAS) score and muscle volume, following international consensus guidelines. | Procedure or surgery | Hybrid Neuro-Chemodenervation (Phenol + BoNT-A), Standard Chemodenervation (BoNT-A Alone) |
Primary outcome
Change from Baseline in the Modified Ashworth Scale (MAS) at 4 and 12 weeks.
Time frame: Baseline, 4 weeks, 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.
5 secondary outcomes
Change from Baseline in Fugl-Meyer Assessment for Upper Extremity (FMA-UE).
Time frame: Baseline, 4 weeks, and 12 weeks.
Goal Attainment Scale (GAS).
Time frame: 4 weeks and 12 weeks.
Change from Baseline in Resting Motor Threshold (RMT) of both hemispheres.
Time frame: Baseline, 4 weeks, and 12 weeks.
Change from Baseline in Cortical Silent Period (CSP) duration.
Time frame: Baseline, 4 weeks, and 12 weeks.
Total Dose of Botulinum Toxin Type A (BoNT-A) administered.
Time frame: Day 0 (at time of injection).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- BackgroundAnwar F, Ramanathan S. Combined Botulinum Toxin Injections and Phenol Nerve / Motor Point Blocks to Manage Multifocal Spasticity in Adults. British Journal of Medical Practitioners. March 2017;10(1):a1002.
- Background: PubMed 14991818Murase N, Duque J, Mazzocchio R, Cohen LG. Influence of interhemispheric interactions on motor function in chronic stroke. Ann Neurol. 2004 Mar;55(3):400-9. doi: 10.1002/ana.10848.
- Results publication: PubMed 25797650Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.
- Results publication: PubMed 29675072Gonnade N, Lokhande V, Ajij M, Gaur A, Shukla K. Phenol Versus Botulinum Toxin A Injection in Ambulatory Cerebral Palsy Spastic Diplegia: A Comparative Study. J Pediatr Neurosci. 2017 Oct-Dec;12(4):338-343. doi: 10.4103/jpn.JPN_123_17.
- Results publication: PubMed 19197564Wissel J, Ward AB, Erztgaard P, Bensmail D, Hecht MJ, Lejeune TM, Schnider P, Altavista MC, Cavazza S, Deltombe T, Duarte E, Geurts AC, Gracies JM, Haboubi NH, Juan FJ, Kasch H, Katterer C, Kirazli Y, Manganotti P, Parman Y, Paternostro-Sluga T, Petropoulou K, Prempeh R, Rousseaux M, Slawek J, Tieranta N. European consensus table on the use of botulinum toxin type A in adult spasticity. J Rehabil Med. 2009 Jan;41(1):13-25. doi: 10.2340/16501977-0303.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made publicly available to protect the privacy and confidentiality of the participants, in accordance with the ethical guidelines of the Assiut University Hospital Institutional Review Board. Furthermore, the data is being utilized for a Doctoral (PhD) thesis. Summary results and aggregated data will be shared through peer-reviewed publications and the final thesis dissertation upon completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammad Korayem, Master's degree principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing phenol neurolysis and Botulinum Toxin - A injections in people with Spasticity as Sequela of Stroke, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Ahmad Korayem, Master's degree (+201021478054, Mohammadkorayem@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Modified Ashworth Scale (MAS) at 4 and 12 weeks. (time frame: Baseline, 4 weeks, and 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07440173, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.