Botulinum Toxin A Adult Gastrocnemius Muscle Study

Stroke Clinical Trial

— BTX-A  

Official title:

An Efficacy Comparison of Botulinum Toxin A Injection Into Two Different Sites in Gastrocnemius Muscle for the Treatment of Spastic Patients, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01278576
• Other study ID #: BCMC10AH07
• Status: Completed
• Phase: Phase 4
• First received: January 10, 2011
• Last updated: May 14, 2012
• Start date: January 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2011
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the effectiveness of BOTOX-A® (botulinun toxin A) placed between two different injection sites, namely at the proximal portion of the gastrocnemius(GCM) versus at the midbelly of the GCM.

Description:

Previous studies have used the midbelly of a muscle as the position where the motor endplates are most densely located. The reasoning behind this method was based on the previous works that showed most bands of cholinesterase activity to be located in specific topographical patterns at the center of the muscle fiber. These results have been used as landmarks to place the injections. Current standard guidelines recommend that botulinum toxin be placed at the 4 quadrants of the midbelly portion of the gastrocnemius (GCM) muscle. However, recent cadaveric research studies on the distribution of the intramuscular endings of the GCM suggest that the highest branch density is found within the upper 20-30% length of the calf. Therefore, in accordance to the theory that effect of botulinum toxin are greatest at sites where the intramuscular endings are most dense, the location where these toxins should be placed would be at these proximal sites of the GCM rather than at the midbelly.

40 recruited patients will be allocated into either the intramuscular ending targeted (ie.upper portion of calf) or midbelly targeted group.

Each subject will undergo a total number of 4 assessments; prior to the injection and 2,4and 8 weeks post injection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male or female, 20 < age < 70 year old

• Hemiplegia documented after ischemic or hemorrhagic stroke, documented by CT (computed tomography) or MRI (magnetic resonance imaging) scan

• Time between the onset of stroke < 24 months

• Individuals who have been medically stable for at least 4 weeks prior to study enrollment

• Confirmed equinovarus with spastic hypertonia of the ankle

• Spasticity as defined by a MAS greater than grade 1 +

• Botulinum toxin -naive patients

• Participants who can complete the 10 meter walking test with caregiver or walking tool assistance within 8 and 45 seconds, on 2 occasions

• Participants who will have stable treatment regimen and concomitant medication during the trial period

Exclusion Criteria:

• The patient has any of the following medical conditions that is contraindication to botulinum toxin exposure; pregnancy, lactation, neuromuscular disease, aminoglycoside, antibiotic concurrent to botulinum toxin treatment

• Fixed contracture of the ankle, previous history of surgical procedure performed on the ankle

• Cognitive deficit that disables patients to give informed consent to the procedure

• Concomitant progression of any CNS (central nervous system) or PNS (peripheral nervous system), or myopathy, or uncontrolled seizure. Underlying CNS insult should be controlled and in stable condition with no further risk of progression and further deterioration of patient's current neurological status. Those with multiple sclerosis or multiple systemic atrophy are to be excluded

• Significant cutaneous or joint inflammation

• URI or other systemic infection that would mandate the use of antibiotic concurrent to botulinum toxin injection

• Anticoagulation treatment with INR (International Normalized Ratio) greater than 3.0

• Upper extremity spasticity greater than MAS grade 4 that may limit gait function

• Subjects with previous episodes of motor point block injection using phenol or other chemodenervating agents

• Subjects with intrathecal baclofen pump

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Spasticity
• Stroke

Intervention

Drug:
• BOTOX-A®
200 units, single treatment only

Locations

Country	Name	City	State
Korea, Republic of	Department of Rehabilitation Medicine Bucheon St Mary's Hospital, Catholic University of Korea, College of Medicine	Bucheon	Kyounggido
Korea, Republic of	Bobath Memorial Hospital	Songnam	Kyoungido

Sponsors (2)

Lead Sponsor	Collaborator
The Catholic University of Korea	Bobath Memorial Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline for EMG (electromyogram) activity	Surface EMG	week 8	No
Secondary	Change from baseline of GCM tone a measured on the Modified Ashworth Scale (MAS)		Change from baseline at 8 weeks	No
Secondary	Change from baseline of Ankle Range of motion	Passive range of motion of the ankle at resting state with the use of goniometer	Change from baseline at 8 weeks	No
Secondary	Change from baseline of gait speed with 10 meters walk test	Change from baseline at 8 weeks	Change from baseline at 8 weeks	No
Secondary	Change from baseline of ABILOCO scale		Change from baseline at 8 weeks	No
Secondary	Change from baseline of Disability Assessment Scale		Change from baseline at 8 weeks	No
Secondary	Change from baseline of Functional Ambulation Category Scale		Change from baseline at 8 weeks	No
Secondary	Change of baseline of Lindmark Modified Fugyl Meyer Scale		Change from baseline at 8 weeks	No
Secondary	Change from baseline of Tardieu angle of ankle		Change from baseline at 8 weeks	No