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

NCT01786005 | Unknown Phase 4 DMC

• 1 other identifier: TMS-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Spasticity, Multiple Sclerosis, Stroke, Trauma

Outcome Measures

Primary Outcomes (2)

• Stroke

  20 days

• Epileptic seizure

  20 days

Secondary Outcomes (1)

• The patient is discharged from clinic

  20 days

Other Outcomes (1)

• Pregnancy

  20 days

Study Arms (4)

Sham

SHAM COMPARATOR

Imitation of stimulation.

Device: Transcranial magnetic stimulation

High-frequency stimulation

EXPERIMENTAL

High-frequency stimulation

Device: Transcranial magnetic stimulation

TBS Theta burst stimulation

EXPERIMENTAL

TBS Theta burst stimulation

Device: Transcranial magnetic stimulation

Low-frequency stimulation

EXPERIMENTAL

Low-frequency stimulation

Device: Transcranial magnetic stimulation

Interventions

Transcranial magnetic stimulation DEVICE

High-frequency stimulation; Low-frequency stimulation; Sham; TBS Theta burst stimulation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

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

Sponsors & Collaborators

• Russian Academy of Medical Sciences: lead

Study Sites (1)

Research center of neurology RAMS

Moscow, Volokolamskoe Shosse, 80, 125367, Russia

RECRUITING

Related Publications (21)

• Korniukhina EIu, Chrnikova LA, Ivanova-Smolenskaia IA, Karabanov AV. [Application of transcranial pulsed electrostimulation and an alternating electrostatic field to the treatment of "restless legs" syndrome in patients with Parkinson disease]. Vopr Kurortol Fizioter Lech Fiz Kult. 2010 Mar-Apr;(2):38-41. Russian.

  PMID: 21089214 BACKGROUND

• Kremneva EI, Chernikova LA, Konovalov RN, Krotenkova MV, Saenko IV, Kozlovskaia IB. [Activation of the sensorimotor cortex with the use of a device for the mechanical stimulation of the plantar support zones]. Fiziol Cheloveka. 2012 Jan-Feb;38(1):61-8. Russian.

  PMID: 22567837 BACKGROUND

• Valero-Cabre A, Pascual-Leone A. Impact of TMS on the primary motor cortex and associated spinal systems. IEEE Eng Med Biol Mag. 2005 Jan-Feb;24(1):29-35. doi: 10.1109/memb.2005.1384097. No abstract available.

  PMID: 15709533 BACKGROUND

• Mori F, Koch G, Foti C, Bernardi G, Centonze D. The use of repetitive transcranial magnetic stimulation (rTMS) for the treatment of spasticity. Prog Brain Res. 2009;175:429-39. doi: 10.1016/S0079-6123(09)17528-3.

  PMID: 19660671 BACKGROUND

• Young RR. Spasticity: a review. Neurology. 1994 Nov;44(11 Suppl 9):S12-20.

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• Katz R, Pierrot-Deseilligny E, Hultborn H. Recurrent inhibition of motoneurones prior to and during ramp and ballistic movements. Neurosci Lett. 1982 Aug 16;31(2):141-5. doi: 10.1016/0304-3940(82)90106-9. No abstract available.

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• Katz R, Pierrot-Deseilligny E. Recurrent inhibition in humans. Prog Neurobiol. 1999 Feb;57(3):325-55. doi: 10.1016/s0301-0082(98)00056-2.

  PMID: 10096844 BACKGROUND

• Valle AC, Dionisio K, Pitskel NB, Pascual-Leone A, Orsati F, Ferreira MJ, Boggio PS, Lima MC, Rigonatti SP, Fregni F. Low and high frequency repetitive transcranial magnetic stimulation for the treatment of spasticity. Dev Med Child Neurol. 2007 Jul;49(7):534-8. doi: 10.1111/j.1469-8749.2007.00534.x.

  PMID: 17593127 BACKGROUND

• Valero-Cabre A, Oliveri M, Gangitano M, Pascual-Leone A. Modulation of spinal cord excitability by subthreshold repetitive transcranial magnetic stimulation of the primary motor cortex in humans. Neuroreport. 2001 Dec 4;12(17):3845-8. doi: 10.1097/00001756-200112040-00048.

  PMID: 11726806 BACKGROUND

• Kumru H, Murillo N, Samso JV, Valls-Sole J, Edwards D, Pelayo R, Valero-Cabre A, Tormos JM, Pascual-Leone A. Reduction of spasticity with repetitive transcranial magnetic stimulation in patients with spinal cord injury. Neurorehabil Neural Repair. 2010 Jun;24(5):435-41. doi: 10.1177/1545968309356095. Epub 2010 Jan 6.

  PMID: 20053952 BACKGROUND

• Mori F, Ljoka C, Magni E, Codeca C, Kusayanagi H, Monteleone F, Sancesario A, Bernardi G, Koch G, Foti C, Centonze D. Transcranial magnetic stimulation primes the effects of exercise therapy in multiple sclerosis. J Neurol. 2011 Jul;258(7):1281-7. doi: 10.1007/s00415-011-5924-1. Epub 2011 Feb 1.

  PMID: 21286740 BACKGROUND

• Chen R, Classen J, Gerloff C, Celnik P, Wassermann EM, Hallett M, Cohen LG. Depression of motor cortex excitability by low-frequency transcranial magnetic stimulation. Neurology. 1997 May;48(5):1398-403. doi: 10.1212/wnl.48.5.1398.

  PMID: 9153480 BACKGROUND

• Chen JT, Chen CC, Kao KP, Wu ZA, Liao KK. Conditioning effect on the long latency potentials in the lower limb to transcranial magnetic stimulation. Acta Neurol Scand. 1998 Dec;98(6):412-21. doi: 10.1111/j.1600-0404.1998.tb07323.x.

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• Berardelli A, Inghilleri M, Rothwell JC, Romeo S, Curra A, Gilio F, Modugno N, Manfredi M. Facilitation of muscle evoked responses after repetitive cortical stimulation in man. Exp Brain Res. 1998 Sep;122(1):79-84. doi: 10.1007/s002210050493.

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• Touge T, Gerschlager W, Brown P, Rothwell JC. Are the after-effects of low-frequency rTMS on motor cortex excitability due to changes in the efficacy of cortical synapses? Clin Neurophysiol. 2001 Nov;112(11):2138-45. doi: 10.1016/s1388-2457(01)00651-4.

  PMID: 11682353 BACKGROUND

• Perez MA, Lungholt BK, Nielsen JB. Short-term adaptations in spinal cord circuits evoked by repetitive transcranial magnetic stimulation: possible underlying mechanisms. Exp Brain Res. 2005 Apr;162(2):202-12. doi: 10.1007/s00221-004-2144-2. Epub 2004 Dec 7.

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• Conte A, Belvisi D, Iezzi E, Mari F, Inghilleri M, Berardelli A. Effects of attention on inhibitory and facilitatory phenomena elicited by paired-pulse transcranial magnetic stimulation in healthy subjects. Exp Brain Res. 2008 Apr;186(3):393-9. doi: 10.1007/s00221-007-1244-1. Epub 2008 Jan 23.

  PMID: 18214454 BACKGROUND

• Di Lazzaro V, Pilato F, Oliviero A, Dileone M, Saturno E, Mazzone P, Insola A, Profice P, Ranieri F, Capone F, Tonali PA, Rothwell JC. Origin of facilitation of motor-evoked potentials after paired magnetic stimulation: direct recording of epidural activity in conscious humans. J Neurophysiol. 2006 Oct;96(4):1765-71. doi: 10.1152/jn.00360.2006. Epub 2006 Jun 7.

  PMID: 16760345 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis; Stroke; Wounds and Injuries

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Alexander V Chervyakov, PhD

CONTACT

+79161831088; tchervyakovav@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Russian academy of medical science

Study Record Dates

• First Submitted: February 5, 2013
• First Posted: February 7, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2015
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

RU (1)