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

This study is currently recruiting participants.
Verified April 2013 by Russian Academy of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Chervyakov Alexander, Russian Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01786005
First received: February 5, 2013
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention Phase
Spasticity, Multiple Sclerosis, Stroke, Trauma
Device: Transcranial magnetic stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Antispastic Effect of Transcranial Magnetic Stimulation in Patients With Cerebral and Spinal Spasticity

Resource links provided by NLM:


Further study details as provided by Russian Academy of Medical Sciences:

Primary Outcome Measures:
  • Stroke [ Time Frame: 20 days ] [ Designated as safety issue: Yes ]
  • Epileptic seizure [ Time Frame: 20 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The patient is discharged from clinic [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Pregnancy [ Time Frame: 20 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2013
Estimated Study Completion Date: February 2015
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
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
Study First Received: February 5, 2013
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration
Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Multiple Sclerosis
Muscle Spasticity
Sclerosis
Stroke
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
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 21, 2014