Spinal Cord InjurySCIMAGNCT02333695
Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCI)
A study testing Spinal Magnetic Stimulation in people with Spinal Cord Injury and Stroke, run by American Society Of Thermalism And Climatology Inc at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Stroke
- What is being tested?
- Spinal Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed consent;
- persons with confirmed and verified lesion of the central nervous system
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Gaviota Clinic
Newark, New Jersey, 07105
Garis Silega, Dr, 973-842-6230, drsilega@aol.com
Garis Silega, Dr
About this study
Official title: Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCIMAG)
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.
Read the 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
- Conditions
- Spinal Cord Injury, Stroke
- Being tested
- Spinal Magnetic Stimulation
- Keywords
- SCI, Spinal Cord Injury, Stroke
- Medical subject headings
- Spinal Cord Injuries, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Magnetic StimulationDevice
Also called SMS
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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Magnetic Stimulation | Experimental | 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. Receives: Device: Spinal Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction Hiperrelexia
Measured: 30 days
Secondary outcomes (3)
Stimulate an erection
Measured: 45 days
Stimulate bowel movements
Measured: 30 days
Stimulate bladder emptying
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Society Of Thermalism And Climatology Inc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Garis Silega, MD, Principal investigator, America Society of thermalism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333695
- Sponsor's protocol ID
- Gavionerrvemag
- Acronym
- SCIMAG
- Status last verified
- Jan 2015
- First submitted
- 5 Jan 2015
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCIMAG)
- ClinicalTrials.gov ID
- NCT02333695
- Acronym / sponsor ID
- SCIMAG / Gavionerrvemag
- Conditions
- Spinal Cord Injury, Stroke
- Keywords
- SCI, Spinal Cord Injury, Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- American Society Of Thermalism And Climatology IncUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 7 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Magnetic Stimulation | Experimental | Device: Spinal Magnetic StimulationSpinal 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- informed consent;
- persons with confirmed and verified lesion of the central nervous system
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Magnetic StimulationAlso: SMSSpinal 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 |
Primary outcome
Reduction Hiperrelexia
Time frame: 30 days
3 secondary outcomes
Stimulate an erection
Time frame: 45 days
Stimulate bowel movements
Time frame: 30 days
Stimulate bladder emptying
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
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Brief Prolonged Exposure Therapy Versus Clinical Standard to Reduce Posttraumatic Stress Post Spinal Cord Injury
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Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Garis Silega, MD principal investigator
America Society of thermalism
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Magnetic Stimulation in people with Spinal Cord Injury and Stroke, run by American Society Of Thermalism And Climatology Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Garis Silega, MD (9738426230, drsilega@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction Hiperrelexia (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.