SpasticityEarly Phase 1EARLY BOT-SPASNCT06811142

Early Botulinum Toxin for Muscle Stiffness Reduction in First-Time Stroke Patients: Improving Recovery and Independence

A Early Phase 1 study testing Botulinum Toxin Type A (BoNT-A) in people with Spasticity and Stroke, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Spasticity, Stroke, Neurological Rehabilitation
What is being tested?: Botulinum Toxin Type A (BoNT-A)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 1 siteMexico
Study dates: 1 Dec 2026to 1 Feb 2030
Phase: Early Phase 1
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women ≥18 years old. Beneficiaries treated in the Emergency and/or Internal Medicine service at HGR No. 1, IMSS Mérida, Yucatán, with an acute stroke confirmed by clinical symptoms and a new ischemic lesion detected through magnetic resonance imaging or computed tomography within 7 days of onset.

Who cannot join

Severe cognitive deficits.
Severe language comprehension disorders.
Lack of capacity to give informed consent.
Physical disability already existing before the acute stroke.
Subarachnoid hemorrhage.
Transient ischemic attack.

Show all 10Show fewer

Any other neurological disorder that could affect muscle tone (Conditions related to the spine, brain infection and traumatic brain injury).
Any amputation of the limb on the affected side.
Peripheral neuropathy of the upper and/or lower limbs.
Patients who have suffered a previous stroke.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mexico1 site

Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.
Mérida, Yucatán, 97155
Roberto C Pech Arguelles, Master, 9991520786, drrobertopech@hotmail.com
Shilia Lisset SL Vargas Echeverría, Doctor

Other trials in Mexico

About this study

Official title: EVALUATION OF THE EFFECTS OF EARLY APPLICATION OF BOTULINUM TOXIN IN PATIENTS WITH A FIRST CEREBRAL VASCULAR EVENT.

This study examines the early use of botulinum toxin in patients recovering from their first stroke to help reduce muscle stiffness and improve mobility. Spasticity, a condition that causes abnormal muscle tightness, is a common complication following strokes. It can result in decreased independence, pain, joint contractures, and difficulty performing daily activities. Early intervention is critical to prevent long-term complications and improve recovery outcomes.The participants are men and women aged 18 and older who have recently experienced their first stroke. These patients, admitted to the Regional General Hospital No. 1 "Lic. Ignacio García Téllez" in Mérida, Yucatán, will receive botulinum toxin injections alongside a comprehensive rehabilitation program. Botulinum toxin, commonly known for its muscle-relaxing effects, will be administered within the first three months after the stroke. This early timeline aims to maximize recovery by addressing muscle tightness before it worsens.The study will evaluate how the combination of botulinum toxin and physical therapy affects muscle tone, functional independence, and overall quality of life. Key measurements include the Modified Ashworth Scale (MAS) to assess muscle stiffness, the Barthel Index to evaluate daily activity independence, and cognitive assessments to monitor brain recovery. Patients' progress will be tracked over several months to measure the intervention's short, medium, and long-term impact.Previous research suggests that early application of botulinum toxin can prevent long-lasting muscle contractures and improve mobility, but more studies are needed to confirm its benefits in stroke rehabilitation. The results of this research could help establish early botulinum toxin injections as a standard practice in stroke recovery programs, reducing disability and healthcare costs while improving the lives of stroke survivors.

Read the detailed description

This clinical study evaluates the impact of early application of botulinum toxin on patients experiencing their first cerebrovascular event. Spasticity, characterized by abnormal muscle stiffness and involuntary muscle contractions, is a frequent complication of strokes that can lead to reduced mobility, pain, joint deformities, and a diminished ability to perform daily activities. The study aims to determine whether early intervention with botulinum toxin, in combination with rehabilitation therapy, can mitigate the development and severity of post-stroke spasticity, improve muscle tone, and enhance functional outcomes.

Patients eligible for participation include men and women aged 18 and older, admitted with a confirmed diagnosis of a recent stroke within the first seven days of symptom onset. The intervention will involve botulinum toxin injections administered within the early subacute phase (up to 12 weeks post-stroke) to maximize the neuroplastic window and reduce the risk of permanent muscle contractures. The study will be conducted over three years at the Regional General Hospital No. 1 "Lic. Ignacio García Téllez," Mérida, Yucatán.

The primary outcomes assessed will include changes in muscle tone, evaluated by the Modified Ashworth Scale (MAS), and functional independence, measured using the Barthel Index. Secondary outcomes will assess quality of life, cognitive performance, and overall rehabilitation progress through tools such as the Mini-Mental State Examination (MMSE) and the Fugl-Meyer Assessment Scale. The study design is a prospective, controlled clinical trial comparing patients receiving early botulinum toxin injections with those undergoing standard rehabilitation only.

This research aims to provide valuable clinical evidence regarding the effectiveness of early botulinum toxin application in preventing long-term disabilities, enhancing recovery, and reducing healthcare burdens associated with post-stroke spasticity. By identifying clinical predictors of spasticity, the study will contribute to the development of targeted, time-sensitive interventions that optimize stroke rehabilitation outcomes.

Conditions: Spasticity, Stroke, Neurological Rehabilitation
Being tested: Botulinum Toxin Type A (BoNT-A)
Keywords: NEUROPLASTICITY, Post-Stroke Spasticity, Stroke Rehabilitation, Early Intervention, Botulinum Toxin (BoNT-A), Modified Ashworth Scale
Medical subject headings: Muscle Spasticity, Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Botulinum Toxin Type A (BoNT-A)Drug
Also called Botulinum Neurotoxin A, BoNT-A, AbobotulinumtoxinA
This intervention involves the early administration of botulinum toxin type A (BoNT-A) within the first 12 weeks after a cerebrovascular event. The injections target muscles affected by spasticity, aiming to reduce abnormal tone, prevent contractures, and improve functional mobility. BoNT-A works by blocking acetylcholine release at the neuromuscular junction, resulting in muscle relaxation. Ultrasound guidance or anatomical landmarks will be used for accurate injection. This early intervention capitalizes on the neuroplastic window and is combined with standard rehabilitation to enhance motor recovery and prevent long-term complications.

Study groups in NCT06811142
Study group	Role	What they receive
intervention	Active comparator	Participants in the intervention group will receive early botulinum toxin type A (BoNT-A) injections in addition to a standard rehabilitation program. The botulinum toxin will be administered within the first 12 weeks following stroke onset, targeting muscles affected by spasticity. The injections aim to reduce abnormal muscle tone, prevent contractures, and improve functional mobility. Rehabilitation therapy will include physical exercises, range-of-motion activities, and muscle-strengthening interventions tailored to individual recovery needs. The combined therapy is designed to optimize motor function, promote neuroplasticity, and improve overall independence and quality of life. Receives: Drug: Botulinum Toxin Type A (BoNT-A)
control	No intervention	Participants in the control group will undergo a standard rehabilitation program without the early application of botulinum toxin. The rehabilitation will consist of physical therapy focused on improving muscle strength, range of motion, and functional independence. Treatment will be tailored to each participant's condition and recovery progress, following established post-stroke rehabilitation protocols. This group will serve as the comparator to evaluate the additional benefits of early botulinum toxin intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Ashworth Scale
The Modified Ashworth Scale (MAS) is a 6-point ordinal scale (0, 1, 1+, 2, 3, 4) used to assess spasticity by evaluating resistance during passive movement of a joint. The scoring system is as follows:
0: No increase in muscle tone.
1: Slight increase in tone, with a catch and release or minimal resistance at the end of the range of motion.
1+: Slight increase in tone, with a catch followed by minimal resistance throughout less than half of the range of motion.
2: More marked increase in tone through most of the range, but the joint moves easily.
3: Considerable increase in tone, making passive movement difficult. 4: Affected part is rigid in flexion or extension.
Measured: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
MODIFIED TARDIEU SCALE
The Modified Tardieu Scale (MTS) assesses spasticity by measuring muscle response to passive stretching at different velocities. It evaluates both the angle of muscle reaction (R1) and the final range of motion (R2). The key feature of the MTS is its sensitivity to velocity-dependent resistance, distinguishing it from the Modified Ashworth Scale. Joint movement is tested at three speeds: slow (V1), normal (V2), and fast (V3). The difference between R1 and R2 reflects dynamic spasticity and muscle stiffness.
The scale assigns qualitative scores (0-5) based on the severity of the muscle reaction:
0: No resistance throughout the movement.
1. Slight resistance with no clear catch.
2. Clear catch at a precise angle, followed by release.
3. Fatigable clonus with fewer than 10 seconds of contraction.
4. Unfatigable clonus lasting more than 10 seconds.
5. Joint is immobile.
Measured: Baseline (within 7 days post-stroke) 8 weeks post-intervention 12 weeks post-intervention 6 months post-intervention 12 months post-intervention

Secondary outcomes (7)

MINI MENTAL STATE EXAMINATION
The Mini-Mental State Examination (MMSE) is a widely used screening tool to assess cognitive function, often employed in stroke rehabilitation studies to monitor neurological recovery. The test evaluates five cognitive domains: orientation, immediate memory, attention and calculation, recall, and language. It includes tasks such as recalling objects, following commands, and answering orientation questions. The MMSE is scored out of 30 points, with higher scores indicating better cognitive function.
A score of 24 or higher is generally considered normal, while scores below this threshold suggest varying degrees of cognitive impairment. The MMSE will be administered at different intervals to assess how early intervention with botulinum toxin and rehabilitation affects patients' cognitive recovery. Its role as a secondary outcome helps determine whether improvements in motor function correlate with cognitive benefits during stroke rehabilitation.
Measured: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
BARTHEL INDEX
The Barthel Index is a standardized tool used to assess a patient's level of independence in performing basic activities of daily living (ADLs). It evaluates 10 tasks, including feeding, bathing, dressing, using the toilet, walking, and controlling bladder and bowel movements. Each task is scored based on the patient's ability to perform the activity independently or with assistance. The total score ranges from 0 to 100, with higher scores indicating greater independence.
0 points: Complete dependence 100 points: Full independence
Measured: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
NIHSS SCALE
The NIHSS Scale is a clinical tool used to assess the severity of neurological deficits in patients who have experienced a stroke. It evaluates multiple domains, including level of consciousness, motor function, sensory abilities, language, coordination, and visual fields. The scale consists of 15 items, each scored from 0 to 4, with a maximum score of 42 indicating severe stroke and a score of 0 indicating no neurological deficits.
Key categories assessed include:
Motor Function: Arm and leg movement Sensory Function: Response to tactile stimuli Language and Speech: Aphasia or dysarthria Level of Consciousness: Alertness and responsiveness
Measured: BASELINE 1 month post-intervention
Modified Rankin Scale
The Modified Rankin Scale (mRS) is a 7-point ordinal scale used to measure functional status and the degree of disability or dependence in activities of daily living following a stroke. It evaluates outcomes ranging from no symptoms (0) to severe disability or death (6). The scale is widely used in stroke rehabilitation to monitor recovery and assess long-term functional outcomes.
Scoring:
0: No symptoms.
1. No significant disability; able to carry out all usual activities.
2. Slight disability; unable to perform all previous activities but manages without assistance.
3. Moderate disability; requires some help but can walk without assistance.
4. Moderately severe disability; unable to walk or attend to bodily needs without assistance.
5. Severe disability; requires constant nursing care and attention.
6. Death.
Measured: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
Fugl-Meyer Upper and Lower Extremity Scale
The Fugl-Meyer Assessment (FMA) for Upper and Lower Extremities is a widely used, validated tool to evaluate motor recovery after stroke. It assesses motor function, balance, sensation, and joint movement through a series of tasks designed to measure impairments in the affected limbs. The assessment is divided into two parts:
1. Upper Extremity (FMA-UE) Focuses on shoulder, elbow, wrist, hand, and coordination tasks. Tasks are scored from 0 (no function) to 2 (normal function) based on movement ability, precision, and control. Maximum score: 66 points for the upper limb.
2. Lower Extremity (FMA-LE) Evaluates hip, knee, and ankle movement, including weight-bearing tasks and reflex activity.
Similar scoring from 0 to 2 per task, with a maximum score of 34 points for the lower limb.
Key Areas Assessed:
Voluntary Movement: Flexion, extension, and joint movement. Coordination and Speed: Smoothness and accuracy of movements.
Measured: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
Goal Attainment Scaling
Goal Attainment Scaling (GAS) is an individualized, patient-centered tool used to measure the extent to which a patient achieves predetermined rehabilitation goals. It involves setting specific, measurable goals tailored to the patient's condition, which can include improvements in motor function, independence, pain reduction, or daily activities. Each goal is rated on a 5-point scale, ranging from -2 to +2, where:
- 2: Much less than expected outcome.
- 1: Somewhat less than expected outcome. 0: Expected outcome achieved.
- 1: Somewhat better than expected outcome.
- 2: Much better than expected outcome.
Measured: Baseline (within 7 days post-stroke) 6 months post-intervention 12 months post-intervention
MEDICAL RESEARCH COUNCIL
The MRC Scale is a validated clinical tool used to assess muscle strength in patients with neurological or muscular impairments, such as after a stroke. It evaluates the ability of specific muscle groups to generate force against resistance. Each muscle group is tested, and strength is graded on a 6-point ordinal scale (0 to 5):
0: No muscle contraction observed.
1. Flicker of contraction, but no visible joint movement.
2. Active movement possible only with gravity eliminated.
3. Active movement against gravity, but no resistance.
4. Active movement against gravity and some resistance.
5. Normal strength, full movement against maximum resistance.
Measured: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20261 Feb 2030

First posted6 Feb 2025
Study start1 Dec 2026 (estimated)
Primary completion1 Feb 2027 (estimated)
Study completion1 Feb 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (16)Papers the sponsor has linked to this study.
Other trials for SpasticityStudies of the same condition, open and under way.
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: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: This study uses a Parallel Assignment Model with two groups: an intervention group receiving early botulinum toxin (BoNT-A) injections and a control group undergoing standard rehabilitation without the toxin. The intervention aims to prevent spasticity-related complications by leveraging early treatment during the neuroplastic phase, within 12 weeks post-stroke. Randomized and controlled conditions will ensure unbiased results, with outcomes measured over short, medium, and long-term follow-up periods.
Masking: None (open label)
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06811142
Sponsor's protocol ID: R-2024-3201-072
Acronym: EARLY BOT-SPAS
Status last verified: Nov 2026
First submitted: 31 Jan 2025
Last updated: 4 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Kong KH, Lee J, Chua KS. Occurrence and temporal evolution of upper limb spasticity in stroke patients admitted to a rehabilitation unit. Arch Phys Med Rehabil. 2012 Jan;93(1):143-8. doi: 10.1016/j.apmr.2011.06.027.
PubMed 22200394
Opheim A, Danielsson A, Alt Murphy M, Persson HC, Sunnerhagen KS. Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study. Neurology. 2015 Sep 8;85(10):873-80. doi: 10.1212/WNL.0000000000001908. Epub 2015 Aug 14.
PubMed 26276377
Sunnerhagen KS. Predictors of Spasticity After Stroke. Curr Phys Med Rehabil Rep. 2016;4:182-185. doi: 10.1007/s40141-016-0128-3. Epub 2016 Jul 22.
PubMed 27547509
Zeng H, Chen J, Guo Y, Tan S. Prevalence and Risk Factors for Spasticity After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Jan 20;11:616097. doi: 10.3389/fneur.2020.616097. eCollection 2020.
PubMed 33551975
Rosales RL, Efendy F, Teleg ES, Delos Santos MM, Rosales MC, Ostrea M, Tanglao MJ, Ng AR. Botulinum toxin as early intervention for spasticity after stroke or non-progressive brain lesion: A meta-analysis. J Neurol Sci. 2016 Dec 15;371:6-14. doi: 10.1016/j.jns.2016.10.005. Epub 2016 Oct 11.
PubMed 27871449
Patel AT, Ward AB, Geis C, Jost WH, Liu C, Dimitrova R. Impact of early intervention with onabotulinumtoxinA treatment in adult patients with post-stroke lower limb spasticity: results from the double-blind, placebo-controlled, phase 3 REFLEX study. J Neural Transm (Vienna). 2020 Dec;127(12):1619-1629. doi: 10.1007/s00702-020-02251-6. Epub 2020 Oct 27.
PubMed 33106968
11. Stephen, AD (sf). Spasticity in adults: management using botulinum toxin. Royal College of Physicians, 3-22.
Francisco GE, Balbert A, Bavikatte G, Bensmail D, Carda S, Deltombe T, Draulans N, Escaldi S, Gross R, Jacinto J, Ketchum N, Molteni F, Moraleda S, ODell MW, Reebye R, Satero P, Verduzco-Gutierrez M, Walker H, Wissel J. A practical guide to optimizing the benefits of post-stroke spasticity interventions with botulinum toxin A: An international group consensus. J Rehabil Med. 2021 Jan 1;53(1):jrm00134. doi: 10.2340/16501977-2753.
PubMed 33057730
Sunnerhagen KS, Opheim A, Alt Murphy M. Onset, time course and prediction of spasticity after stroke or traumatic brain injury. Ann Phys Rehabil Med. 2019 Nov;62(6):431-434. doi: 10.1016/j.rehab.2018.04.004. Epub 2018 May 16.
PubMed 29753889
Ganguly J, Kulshreshtha D, Almotiri M, Jog M. Muscle Tone Physiology and Abnormalities. Toxins (Basel). 2021 Apr 16;13(4):282. doi: 10.3390/toxins13040282.
PubMed 33923397
Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.
PubMed 33978513
Glaess-Leistner S, Ri SJ, Audebert HJ, Wissel J. Early clinical predictors of post stroke spasticity. Top Stroke Rehabil. 2021 Oct;28(7):508-518. doi: 10.1080/10749357.2020.1843845. Epub 2020 Nov 6.
PubMed 33156735
4. Marlenne, RS (2015). In-hospital mortality due to cerebrovascular diseases in the main public health institutions in Mexico. CONAMED-PAHO BULLETIN, 7-11
3. Cuadrado, A. (2009). Stroke rehabilitation: assessment, prognosis and treatment. Galicia Clinic/Galician Society of Internal Medicine, 25-34.
Cantu-Brito C, Majersik JJ, Sanchez BN, Ruano A, Quinones G, Arzola J, Morgenstern LB. Hospitalized stroke surveillance in the community of Durango, Mexico: the brain attack surveillance in Durango study. Stroke. 2010 May;41(5):878-84. doi: 10.1161/STROKEAHA.109.577726. Epub 2010 Apr 1.
PubMed 20360543

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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EVALUATION OF THE EFFECTS OF EARLY APPLICATION OF BOTULINUM TOXIN IN PATIENTS WITH A FIRST CEREBRAL VASCULAR EVENT.
ClinicalTrials.gov ID: NCT06811142
Acronym / sponsor ID: EARLY BOT-SPAS / R-2024-3201-072
Conditions: Spasticity, Stroke, Neurological Rehabilitation
Keywords: NEUROPLASTICITY, Post-Stroke Spasticity, Stroke Rehabilitation, Early Intervention, Botulinum Toxin (BoNT-A), Modified Ashworth Scale
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: Instituto Mexicano del Seguro SocialOther government
Study start: 1 Dec 2026 (estimated)
Primary completion: 1 Feb 2027 (estimated)
Study completion: 1 Feb 2030 (estimated)
First posted: 6 Feb 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: This study uses a Parallel Assignment Model with two groups: an intervention group receiving early botulinum toxin (BoNT-A) injections and a control group undergoing standard rehabilitation without the toxin. The intervention aims to prevent spasticity-related complications by leveraging early treatment during the neuroplastic phase, within 12 weeks post-stroke. Randomized and controlled conditions will ensure unbiased results, with outcomes measured over short, medium, and long-term follow-up periods.

Arm	Type	Receives
intervention	Active comparator	Drug: Botulinum Toxin Type A (BoNT-A)Participants in the intervention group will receive early botulinum toxin type A (BoNT-A) injections in addition to a standard rehabilitation program. The botulinum toxin will be administered within the first 12 weeks following stroke onset, targeting muscles affected by spasticity. The injections aim to reduce abnormal muscle tone, prevent contractures, and improve functional mobility. Rehabilitation therapy will include physical exercises, range-of-motion activities, and muscle-strengthening interventions tailored to individual recovery needs. The combined therapy is designed to optimize motor function, promote neuroplasticity, and improve overall independence and quality of life.
control	No intervention	–Participants in the control group will undergo a standard rehabilitation program without the early application of botulinum toxin. The rehabilitation will consist of physical therapy focused on improving muscle strength, range of motion, and functional independence. Treatment will be tailored to each participant's condition and recovery progress, following established post-stroke rehabilitation protocols. This group will serve as the comparator to evaluate the additional benefits of early botulinum toxin intervention.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Men and women ≥18 years old. Beneficiaries treated in the Emergency and/or Internal Medicine service at HGR No. 1, IMSS Mérida, Yucatán, with an acute stroke confirmed by clinical symptoms and a new ischemic lesion detected through magnetic resonance imaging or computed tomography within 7 days of onset.

Key exclusion criteria (10 listed)

Severe cognitive deficits.

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
Botulinum Toxin Type A (BoNT-A)Also: Botulinum Neurotoxin A, BoNT-A, AbobotulinumtoxinAThis intervention involves the early administration of botulinum toxin type A (BoNT-A) within the first 12 weeks after a cerebrovascular event. The injections target muscles affected by spasticity, aiming to reduce abnormal tone, prevent contractures, and improve functional mobility. BoNT-A works by blocking acetylcholine release at the neuromuscular junction, resulting in muscle relaxation. Ultrasound guidance or anatomical landmarks will be used for accurate injection. This early intervention capitalizes on the neuroplastic window and is combined with standard rehabilitation to enhance motor recovery and prevent long-term complications.	Drug	intervention

Primary outcome

Modified Ashworth Scale
Time frame: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
The Modified Ashworth Scale (MAS) is a 6-point ordinal scale (0, 1, 1+, 2, 3, 4) used to assess spasticity by evaluating resistance during passive movement of a joint. The scoring system is as follows: 0: No increase in muscle tone. 1: Slight increase in tone, with a catch and release or minimal resistance at the end of the range of motion. 1+: Slight increase in tone, with a catch followed by minimal resistance throughout less than half of the range of motion. 2: More marked increase in tone through most of the range, but the joint moves easily. 3: Considerable increase in tone, making passive movement difficult. 4: Affected part is rigid in flexion or extension.
MODIFIED TARDIEU SCALE
Time frame: Baseline (within 7 days post-stroke) 8 weeks post-intervention 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
The Modified Tardieu Scale (MTS) assesses spasticity by measuring muscle response to passive stretching at different velocities. It evaluates both the angle of muscle reaction (R1) and the final range of motion (R2). The key feature of the MTS is its sensitivity to velocity-dependent resistance, distinguishing it from the Modified Ashworth Scale. Joint movement is tested at three speeds: slow (V1), normal (V2), and fast (V3). The difference between R1 and R2 reflects dynamic spasticity and muscle stiffness. The scale assigns qualitative scores (0-5) based on the severity of the muscle reaction: 0: No resistance throughout the movement. 1. Slight resistance with no clear catch. 2. Clear catch at a precise angle, followed by release. 3. Fatigable clonus with fewer than 10 seconds of contraction. 4. Unfatigable clonus lasting more than 10 seconds. 5. Joint is immobile.

7 secondary outcomes

MINI MENTAL STATE EXAMINATION
Time frame: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
BARTHEL INDEX
Time frame: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
NIHSS SCALE
Time frame: BASELINE 1 month post-intervention
Modified Rankin Scale
Time frame: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
Fugl-Meyer Upper and Lower Extremity Scale
Time frame: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention
Goal Attainment Scaling
Time frame: Baseline (within 7 days post-stroke) 6 months post-intervention 12 months post-intervention
MEDICAL RESEARCH COUNCIL
Time frame: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention

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 4 Nov 2026.
Results publication: PubMed 22200394Kong KH, Lee J, Chua KS. Occurrence and temporal evolution of upper limb spasticity in stroke patients admitted to a rehabilitation unit. Arch Phys Med Rehabil. 2012 Jan;93(1):143-8. doi: 10.1016/j.apmr.2011.06.027.
Results publication: PubMed 26276377Opheim A, Danielsson A, Alt Murphy M, Persson HC, Sunnerhagen KS. Early prediction of long-term upper limb spasticity after stroke: part of the SALGOT study. Neurology. 2015 Sep 8;85(10):873-80. doi: 10.1212/WNL.0000000000001908. Epub 2015 Aug 14.
Results publication: PubMed 27547509Sunnerhagen KS. Predictors of Spasticity After Stroke. Curr Phys Med Rehabil Rep. 2016;4:182-185. doi: 10.1007/s40141-016-0128-3. Epub 2016 Jul 22.
Results publication: PubMed 33551975Zeng H, Chen J, Guo Y, Tan S. Prevalence and Risk Factors for Spasticity After Stroke: A Systematic Review and Meta-Analysis. Front Neurol. 2021 Jan 20;11:616097. doi: 10.3389/fneur.2020.616097. eCollection 2020.
Results publication: PubMed 27871449Rosales RL, Efendy F, Teleg ES, Delos Santos MM, Rosales MC, Ostrea M, Tanglao MJ, Ng AR. Botulinum toxin as early intervention for spasticity after stroke or non-progressive brain lesion: A meta-analysis. J Neurol Sci. 2016 Dec 15;371:6-14. doi: 10.1016/j.jns.2016.10.005. Epub 2016 Oct 11.
Results publication: PubMed 33106968Patel AT, Ward AB, Geis C, Jost WH, Liu C, Dimitrova R. Impact of early intervention with onabotulinumtoxinA treatment in adult patients with post-stroke lower limb spasticity: results from the double-blind, placebo-controlled, phase 3 REFLEX study. J Neural Transm (Vienna). 2020 Dec;127(12):1619-1629. doi: 10.1007/s00702-020-02251-6. Epub 2020 Oct 27.
Results publication11. Stephen, AD (sf). Spasticity in adults: management using botulinum toxin. Royal College of Physicians, 3-22.
Results publication: PubMed 33057730Francisco GE, Balbert A, Bavikatte G, Bensmail D, Carda S, Deltombe T, Draulans N, Escaldi S, Gross R, Jacinto J, Ketchum N, Molteni F, Moraleda S, ODell MW, Reebye R, Satero P, Verduzco-Gutierrez M, Walker H, Wissel J. A practical guide to optimizing the benefits of post-stroke spasticity interventions with botulinum toxin A: An international group consensus. J Rehabil Med. 2021 Jan 1;53(1):jrm00134. doi: 10.2340/16501977-2753.
Results publication: PubMed 29753889Sunnerhagen KS, Opheim A, Alt Murphy M. Onset, time course and prediction of spasticity after stroke or traumatic brain injury. Ann Phys Rehabil Med. 2019 Nov;62(6):431-434. doi: 10.1016/j.rehab.2018.04.004. Epub 2018 May 16.
Results publication: PubMed 33923397Ganguly J, Kulshreshtha D, Almotiri M, Jog M. Muscle Tone Physiology and Abnormalities. Toxins (Basel). 2021 Apr 16;13(4):282. doi: 10.3390/toxins13040282.
Results publication: PubMed 33978513Li S, Francisco GE, Rymer WZ. A New Definition of Poststroke Spasticity and the Interference of Spasticity With Motor Recovery From Acute to Chronic Stages. Neurorehabil Neural Repair. 2021 Jul;35(7):601-610. doi: 10.1177/15459683211011214. Epub 2021 May 12.
Results publication: PubMed 33156735Glaess-Leistner S, Ri SJ, Audebert HJ, Wissel J. Early clinical predictors of post stroke spasticity. Top Stroke Rehabil. 2021 Oct;28(7):508-518. doi: 10.1080/10749357.2020.1843845. Epub 2020 Nov 6.
Individual participant dataSharing planned: No

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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.

Hospital General Regional No.1 "Lic. Ignacio García Téllez" IMSS, Calle 41 101, Fénix, 97155 Mérida, Yuc.

Mérida, Mexico

9991520786

drrobertopech@hotmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Botulinum Toxin Type A (BoNT-A) in people with Spasticity and Stroke, run by Instituto Mexicano del Seguro Social at 1 site in Mexico.

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 1 inclusion and 10 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 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Ashworth Scale (time frame: Baseline (within 7 days post-stroke) 12 weeks post-intervention 6 months post-intervention 12 months post-intervention). The study lists 2 primary outcomes in all. 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 NCT06811142, which also lists 16 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 4 Nov 2026.