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

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 |

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 |
- Stroke [ Time Frame: 20 days ]
- Epileptic seizure [ Time Frame: 20 days ]
- The patient is discharged from clinic [ Time Frame: 20 days ]
- Pregnancy [ Time Frame: 20 days ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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;

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