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

Stroke Clinical Trial

— SCIMAG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02333695
• Other study ID #: Gavionerrvemag
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2015
• Last updated: January 6, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: January 2015
• Source: American Society Of Thermalism And Climatology Inc
• Contact: Garis Silega, MD
• Phone: 9738426230
• Email: drsilega[@]aol.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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;

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	Gaviota Clinic	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
American Society Of Thermalism And Climatology Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reduce muscle spasticity following upper motor neuron lesions		45 days	No
Other	Induce cough to prevent respirator infections.		45 days	Yes
Primary	Reduction Hiperrelexia		30 days	Yes
Secondary	Stimulate an erection		45 days	Yes
Secondary	Stimulate bowel movements		30 days	Yes
Secondary	Stimulate bladder emptying		30 days	Yes