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Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01829763
Recruitment Status : Unknown
Verified July 2014 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : April 11, 2013
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Spasticity is a motor disorder characterized by a velocity-dependent increase in tonic stretch reflex with exaggerated tendon jerk (Lance 1980). Patients with brain lesion often display spasticity due to the interruption of the descending pathways that control the spinal reflex networks, which results in hyperexcitability of the monosynaptic reflex triggered by stretch of the muscle spindles. Spasticity in lower limb muscle impairs the gait, especially in strokes that are the main cause of neurological disability. While 80% of the stroke survivors recover the ability to walk, the poor quality of their gait constitutes a serious handicap in daily life (Bensoussan et al. 2004; Bensoussan et al. 2006).

Local injection of Botulinum toxin (BTx) has become a mainstay of the treatment of focal spasticity, particularly in post-stroke patients. BTx weakens the excessive muscle contraction by blocking the release of acethylcholine from motoneuron terminals at the neuromuscular junction and transiently paralyzing the muscle for several months. Besides this peripheral action, BTx is assumed to have also a central effect (Curra et al. 2004; Gracies 2004; Krishnan 2005; Palomar and Mir 2012). In particular, by affecting also the fusimotor synapses on intrafusal muscles fibers (Rosales and Dressler 2010; Trompetto et al. 2008; Trompetto et al. 2006), BTx may reduce the discharge from muscle spindles, which may be indirectly responsible for functional changes in central motor mechanisms at both spinal and supraspinal levels. Animal experiments also suggested that BTx is carried by retrograde axonal transport to motoneuron soma and possibly transynaptically, and can affect the spinal cholinergic synaptic transmission in the spinal cord. Until now, electrophysiological findings are limited and controversial, probably due to the various motor disorders investigated, the physiological mechanisms tested and the different toxin injection protocols used in the few studies available (Frascarelli et al. 2011; Girlanda et al. 1997; Modugno et al. 1998; Naumann and Reiners 1997; Pauri et al. 2000; Priori et al. 1995; Wohlfarth et al. 2001). Hence, the central action of the toxin in spasticity remains uncertain.


Condition or disease Intervention/treatment Phase
Hemiplegic Patients Post-AVC Drug: injection botox Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Central Effects of Botulinum Toxin: Neurophysiological Study in Stroke Patients With Spastic Lower Limb
Study Start Date : April 2013
Estimated Primary Completion Date : April 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
Experimental: botox Drug: injection botox



Primary Outcome Measures :
  1. injection Botulinum toxin type-A (BTx-A) [ Time Frame: 24 MONTHS ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • More than 18-years-old Patient
  • Patient presenting a hemiplegia séquellaire of an AVC above - tentoriel dating more than 12 months
  • Patient presenting a spasticité of the muscles of the leg
  • Patient for him(it) ( a ) which an indication of treatment(processing) by botulinal toxin is carried(worn)
  • Patient not having received from treatment(processing) by botulinal toxin at the level of the lower limb for six months
  • Patient not having benefited from alcoholization or surgical gesture(movement) at the level of the lower limb for twelve months
  • Spasticité focused the muscles of leg: soleus, gastrocnémiens, with score of Ashworth > or = 2 on the concerned muscles and/or the presence of a clonus on the soleus or gastrocnémiens,

Exclusion Criteria:

  • Patient for him(it) ( a ) which the upright posture and/or the walking(step) are impossible
  • Patient presenting a contraindication to the use of the botulinal toxin
  • Patient presenting a contraindication to the use of the intramuscular way
  • Patient susceptible not to participate in the totality of the study
  • Woman pregnant or susceptible to be pregnant during the year
  • Patient who can not give himself(itself) his consent (held(detained), major under guardianship)
  • Patient incapable to understand(include) the nature and the purposes of the study, or presenting difficulties of understanding which can compromise the good progress of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01829763


Contacts
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Contact: laurent BENSOUSSAN laurent.bensoussan@ap-hm.fr

Locations
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France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: laurent bensoussan       laurent.bensoussan@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: LOIC MONDOLONI Assistance Publique Hopitaux De Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01829763    
Other Study ID Numbers: 2013-000600-42
2013-02 ( Other Identifier: AP HM )
First Posted: April 11, 2013    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases