Medical Device for Magnetic Therapy for Spinal Cord Injuries (SCI)
SCIMAG
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 5, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 7, 2015
January 1, 2015
7 months
January 5, 2015
January 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction Hiperrelexia
30 days
Secondary Outcomes (3)
Stimulate an erection
45 days
Stimulate bowel movements
30 days
Stimulate bladder emptying
30 days
Other Outcomes (2)
Reduce muscle spasticity following upper motor neuron lesions
45 days
Induce cough to prevent respirator infections.
45 days
Study Arms (1)
Spinal Magnetic Stimulation
EXPERIMENTALSpinal 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- informed consent;
- persons with confirmed and verified lesion of the central nervous system
You may not qualify if:
- Identification of the study a total intolerance to a pulsed magnetic field;
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaviota Clinic
Newark, New Jersey, 07105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Garis Silega, MD
America Society of thermalism
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 5, 2015
First Posted
January 7, 2015
Study Start
January 1, 2015
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
January 7, 2015
Record last verified: 2015-01