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Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCI) (SCIMAG)

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ClinicalTrials.gov Identifier: NCT02333695
Recruitment Status : Unknown
Verified January 2015 by American Society Of Thermalism And Climatology Inc.
Recruitment status was:  Recruiting
First Posted : January 7, 2015
Last Update Posted : January 7, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A medical device for magnetic therapy for spinal cord injuries (SCI) will be disclosed. The apparatus comprises a combination of several magnets enclosed in a supportive cover. The magnets are placed in a proper position and their polarity can be changed at any time without any difficulty.

Condition or disease Intervention/treatment
Spinal Cord Injury Stroke Device: Spinal Magnetic Stimulation

Detailed Description:

A medical device for magnetic therapy for spinal cord injuries (SCI) will be disclosed. The apparatus comprises a combination of several magnets enclosed in a supportive cover. The magnets are placed in a proper position and their polarity can be changed at any time without any difficulty.

The device provides a source of stimulation for the nerve to achieve therapeutic results and rehabilitation of patients with spinal trauma or stroke.

A spinal cord injury — damage to any part of the spinal cord or nerves at the end of the spinal canal — often causes permanent changes in strength, sensation and other body functions below the site of the injury.

Many scientists are optimistic that advances in research will someday make the repair of spinal cord injuries possible. Research studies are ongoing around the world. In the meantime, treatments and rehabilitation allow many people with a spinal cord injury to lead productive, independent lives.

The effects of SCI depend on the type of injury and the level of the injury. SCI can be divided into two types of injury - complete and incomplete.

Complete: A complete injury means that there is no function below the level of the injury; no sensation and no voluntary movement. Both sides of the body are equally affected.

Incomplete: An incomplete injury means that there is some functioning below the primary level of the injury. A person with an incomplete injury may be able to move one limb more than another, may be able to feel parts of the body that cannot be moved, or may have more functioning on one side of the body than the other. With the advances in acute treatment of SCI, incomplete injuries are becoming more common.

Spinal Magnetic Stimulation (SMS) is a relatively new way to use magnetism to affect the spinal cord. It is non-invasive, meaning that the procedure does not require any type of surgery; rather, it is conducted by transmitting magnetic pulses through the Spinal Cord by pressing a machine against the back.

The Long term goal of this research project is the implementation of an effective, inexpensive therapy in patients with spinal cord injury. Another objective is the development of a cheap, presentable and comfortable magnetic device that causes neural stimulation to stop and reversing the signs and symptoms of Spinal Cord injury.

The short-term objective is to prove that magneto stimulation is an intervention that reverses the signs and symptoms of Spinal Cord injury in an early and moderate State


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCIMAG)
Study Start Date : January 2015
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Spinal Magnetic Stimulation
Spinal Magnetic Stimulation (SMS) is a relatively new way to use magnetism to affect the spinal cord. It is non-invasive, meaning that the procedure does not require any type of surgery; rather, it is conducted by transmitting magnetic pulses through the Spinal Cord by pressing a machine against the back.
Device: Spinal Magnetic Stimulation
Spinal Magnetic Stimulation (SMS) is a relatively new way to use magnetism to affect the spinal cord. It is non-invasive, meaning that the procedure does not require any type of surgery; rather, it is conducted by transmitting magnetic pulses through the Spinal Cord by pressing a machine against the back.
Other Name: SMS


Outcome Measures

Primary Outcome Measures :
  1. Reduction Hiperrelexia [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Stimulate an erection [ Time Frame: 45 days ]
  2. Stimulate bowel movements [ Time Frame: 30 days ]
  3. Stimulate bladder emptying [ Time Frame: 30 days ]

Other Outcome Measures:
  1. Reduce muscle spasticity following upper motor neuron lesions [ Time Frame: 45 days ]
  2. Induce cough to prevent respirator infections. [ Time Frame: 45 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • informed consent;
  • persons with confirmed and verified lesion of the central nervous system

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 ;
  • Failure of the patient to continue participation in the study;
Contacts and Locations

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): NCT02333695


Contacts
Contact: Garis Silega, MD 9738426230 drsilega@aol.com

Locations
United States, New Jersey
Gaviota Clinic Recruiting
Newark, New Jersey, United States, 07105
Contact: Garis Silega, Dr    973-842-6230    drsilega@aol.com   
Principal Investigator: Garis Silega, Dr         
Sponsors and Collaborators
American Society Of Thermalism And Climatology Inc
Investigators
Principal Investigator: Garis Silega, MD America Society of thermalism
More Information

Responsible Party: American Society Of Thermalism And Climatology Inc
ClinicalTrials.gov Identifier: NCT02333695     History of Changes
Other Study ID Numbers: Gavionerrvemag
First Posted: January 7, 2015    Key Record Dates
Last Update Posted: January 7, 2015
Last Verified: January 2015

Keywords provided by American Society Of Thermalism And Climatology Inc:
SCI, Spinal Cord Injury, Stroke

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System