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Antispastic Effect of Transcranial Magnetic Stimulation in Patients With Cerebral and Spinal Spasticity (ANTMS)

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ClinicalTrials.gov Identifier: NCT01786005
Recruitment Status : Unknown
Verified November 2014 by Chervyakov Alexander, Russian Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : February 7, 2013
Last Update Posted : November 7, 2014
Sponsor:
Information provided by (Responsible Party):
Chervyakov Alexander, Russian Academy of Medical Sciences

Study Description
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Brief Summary:
Spasticity - movement disorder, which is part of the syndrome of defeat top motor-neuron, characterized by the rate-dependent increase in muscle tone and increased dry-core reflections from hyperexcitability of stretch receptors (Lance, 1980). Spasticity - a frequent symptom of neurological diseases (Valero-Cabre, Pascual-Leone, 2005) and may be accompanied by such a disorders consequences of stroke, multiple sclerosis, head trauma and spinal cord, cerebral palsy, etc. The magnitude and severity of spasticity depends on the level of the lesion, the duration of its existence from the time before the disease, and possible plastic changes in axons and synapses on the affected level. There are two basic models of spasticity: cerebral (hemiplegic) and spinal (paraplegicheskaya) (Nikitin, 2005). Cerebral model appears with the direct injury of the brain and is characterized by increased excitability of monosynaptic reflexes with the rapid development of pathological ref-plexes and characteristic hemiplegic posture. Model is characterized by spinal spasticity opposite lower segmental inhibition polysynaptic reflexes slow increase of nervous excitability due to the mechanism of cumulative excitation perevozbuzhdeniem flexor and razgibate-ing, as well as expansion of the area of segmental responses (Nikitin, 2005). As spinal and cerebral spasticity are extremely difficult corrected by standard medical clinic and physiotherapy methods. In this regard, in the world literature actively searched for addi-tional search correct this symptom. A new modern methods that could affect the syndrome of spasticity is rhythmic transcranial magnetic stimulation (Mori et al., 2009).

Condition or disease Intervention/treatment Phase
Spasticity, Multiple Sclerosis, Stroke, Trauma Device: Transcranial magnetic stimulation Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Antispastic Effect of Transcranial Magnetic Stimulation in Patients With Cerebral and Spinal Spasticity
Study Start Date : February 2013
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Sham
Imitation of stimulation.
 Device: Transcranial magnetic stimulation
Experimental: High-frequency stimulation
High-frequency stimulation
 Device: Transcranial magnetic stimulation
Experimental: TBS Theta burst stimulation
TBS Theta burst stimulation
 Device: Transcranial magnetic stimulation
Experimental: Low-frequency stimulation
Low-frequency stimulation
 Device: Transcranial magnetic stimulation


Outcome Measures
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Primary Outcome Measures :
  1. Stroke [ Time Frame: 20 days ]
  2. Epileptic seizure [ Time Frame: 20 days ]

Secondary Outcome Measures :
  1. The patient is discharged from clinic [ Time Frame: 20 days ]

Other Outcome Measures:
  1. Pregnancy [ Time Frame: 20 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

The age of the patients and healthy volunteers from 18 to 70 years

  • persons with confirmed and verified lesion of the central nervous system (the effects of CVD, multiple sclerosis, traumatic brain injury, SMC) with symptoms of spasticity any vyrazhenngosti;
  • informed consent;
  • healthy volunteers who gave informed consent to participate in the study.

The criteria included:

  • The presence of an implanted pacemaker, intracardiac catheters, electronic pumps;
  • The difficult patient, requiring the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats), including an increase of neurological symptoms after 8 days from the start of CVD, acute myocardial infarction, venous thrombosis of the lower extremities, episodes of pulmonary embolism;
  • The severity of the neurological deficit, which does not allow the patient to go through 10 meters (you can use an additional support);
  • Pregnancy or possibility of pregnancy in women of childbearing age (before menopause), according to a pregnancy test;
  • The presence of metal implants or in the head area, located closer than 20 cm from the edge of the surface coil magnetic stimulator, with the exception of the mouth (metal brackets, vascular sutures, metal plate covering defects in the skull, metallic foreign body in the cavity of the skull);
  • Identification of epileptiform activity during the screening EEG prior to the study;
  • Epilepsy or seizures in history;
  • Failure of a patient to participate in the study;

Exclusion Criteria:

  • Identification of the study a total intolerance to a pulsed magnetic field;

    • Development after inclusion of acute myocardial infarction and acute ischemic;
    • Installation of the pacemaker, intracardiac catheters or operations on the brain, requiring the abandonment of metal objects in the cranial cavity;
    • Pregnancy;
    • Enhancement of the patient, which requires the maintenance of vital functions by hardware (mechanical ventilation, continuous application infusomats);
    • The emergence of an epileptic seizure in response to rhythmic TMS;
    • Failure of the patient to continue participation in the study;
Contacts and Locations
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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): NCT01786005


Contacts
Contact: Alexander V Chervyakov, PhD +79161831088 tchervyakovav@gmail.com

Locations
Russian Federation
Research center of neurology RAMS Recruiting
Moscow, Volokolamskoe shosse, 80, Russian Federation, 125367
Contact: Michael A Piradov, professor         
Contact: Ludmila A Chernikova, professor         
Principal Investigator: Alexander V Chervyakov, PhD         
Principal Investigator: Anastasia V Perresedova, PdD, MD         
Principal Investigator: Savitskaya G Natalia, PhD         
Sponsors and Collaborators
Russian Academy of Medical Sciences
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Chervyakov Alexander, Russian academy of medical science, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT01786005     History of Changes
Other Study ID Numbers: TMS-002
TMS-002
First Posted: February 7, 2013    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Multiple Sclerosis
Muscle Spasticity
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms