Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCI) (SCIMAG)
Primary Purpose
Spinal Cord Injury, Stroke
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Magnetic Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injury focused on measuring SCI, Spinal Cord Injury, Stroke
Eligibility 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;
Sites / Locations
- Gaviota ClinicRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal Magnetic Stimulation
Arm Description
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.
Outcomes
Primary Outcome Measures
Reduction Hiperrelexia
Secondary Outcome Measures
Stimulate an erection
Stimulate bowel movements
Stimulate bladder emptying
Full Information
NCT ID
NCT02333695
First Posted
January 5, 2015
Last Updated
January 6, 2015
Sponsor
American Society Of Thermalism And Climatology Inc
1. Study Identification
Unique Protocol Identification Number
NCT02333695
Brief Title
Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCI)
Acronym
SCIMAG
Official Title
Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCIMAG)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Society Of Thermalism And Climatology Inc
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Stroke
Keywords
SCI, Spinal Cord Injury, Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spinal Magnetic Stimulation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Spinal Magnetic Stimulation
Other Intervention Name(s)
SMS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction Hiperrelexia
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Stimulate an erection
Time Frame
45 days
Title
Stimulate bowel movements
Time Frame
30 days
Title
Stimulate bladder emptying
Time Frame
30 days
Other Pre-specified Outcome Measures:
Title
Reduce muscle spasticity following upper motor neuron lesions
Time Frame
45 days
Title
Induce cough to prevent respirator infections.
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Garis Silega, MD
Phone
9738426230
Email
drsilega@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Garis Silega, MD
Organizational Affiliation
America Society of thermalism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaviota Clinic
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Garis Silega, Dr
Phone
973-842-6230
Email
drsilega@aol.com
First Name & Middle Initial & Last Name & Degree
Garis Silega, Dr
12. IPD Sharing Statement
Learn more about this trial
Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCI)
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