None listed
Conditions
Interventions
EXPERIMENTAL TREATMENT GROUP Type of group
This group will be submitted to the standard treatment with the NTS laser system, within 24 hours of the cerebral infarction. A standard treatment of NTS consists of the application in 20 points on the scalp, 2 minutes at each point, of the NTS laser. Which has a power of 5 watts, a continuous wave output with a wavelength of 808 nanometers (+/- 10) and a nominal diameter of the beam of 30 millimeters (approximately 7 cm2).
Group name:PLACEBO CONTROL GROUP Type of group
This group will be submitted to the standard treatment with a NTS Placebo laser system, within 24 hours of the cerebral infarction. Nl NTS Placebo, will be applied in 20 points on the scalp, 2 minutes at each point.
Sponsors
PHOTOTHERA INC.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The Subject is at least 40 years old at the time of detection, but less than 91 years old. 2. The Subject suffers from acute ischemic stroke and presents to the community hospital to receive treatment with NTS within the first 24 hours of the onset of his symptoms. 3. Clinical diagnosis of ischemic stroke as a cause of measurable neurological deficit. 4. Total score on the NIHSS scale of ≥ 7 and ≤ 22 on the NIH ACV Scale evaluated at the time of admission to the Community Hospital. 5. Negative pregnancy test in women with potential risk of pregnancy. 6. The subject and / or their legal representative give their informed consent before enrolling in the study. 7. The Subject wishes to participate in this study for at least 3 months after the start of the ACV. 8. It is the opinion of the Principal Investigator that the Subject is an appropriate candidate for the management of the LCA using an NTS.
Exclusion criteria
Exclusion criteria: 1. The Subject has been presented to the Community hospital more than 24 hours after the start of the ACV. 2. Evidence of intracranial, subdural or subarachnoid hemorrhage on CT or MRI. 3. Clinical picture of the subject suggestive of primary intracranial hemorrhage. 4. Presence of cerebral infarction of the brainstem or cerebellum. 5. Rapid deterioration of neurological status. 6. Subject with presence of value ≥ 3 on the scale of mRS prior to the ACV. 7. The subject had seizures at the beginning of the stroke or seizures were observed in the 7 days prior to enrollment in the study. 8. Serum glucose greater than 400 mg / dl or less than 60 mg / dl. 9. Sustained hypertension or the need for aggressive treatment for the reduction of blood pressure during the initial period. 10. Sustained hypotension. 11. Presumed and / or confirmed septic plunger. 12. CNS tumors. 13. The subject has an alteration of the skin at the chosen site for the application of infrared energy. 14. The subject is a candidate for the administration of intravenous or intraarterial thrombolytic medication for the treatment of acute ischemic stroke and will be given thrombolytic therapy. 15. The subject has previously participated in another study of experimental drugs or devices in the previous 4 weeks. 16. Subject is a woman who is pregnant, breastfeeding or has the potential to become pregnant, unless it is surgically sterile, or she and her partner use a medically acceptable method of contraception. 17. Implant prosthesis in the head. 18. Use of light activated drugs within 14 days prior to enrollment in the study. 19. Coexistence of severe terminal systemic disease. 20. It has been determined by the Investigator that the subject is medically not suitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation according to the Rankin Modified Scale (mRS), which evaluates as success when it has a value of 0-2 and as a failure if the value is 3-6. Measure:Success or failure in the binary mRS scale. Timepoints:90 days after treatment or the last evaluation. ; Outcome name:Criterion 1: The Scale of the National Institute of Health (NIHSS) will evaluate the severity of cerebral infarction in 3 levels (7-10, 11-15 and 16-22) Criterion 2: The TFSO, will be divided into 2: less than 12 hours and 12 to 24 hours. Measure:Primary covariables: 1) Initial value of the NIHSS. 2) Time of onset of symptoms (TFSO) until the moment of randomization. Timepoints:Before starting the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The Scale of the National Institute of Health (NIHSS) will evaluate the severity of cerebral infarction in 3 levels (7-10, 11-15 and 16-22). Measure:Changes in the value of the NIHSS scale between the baseline and the 90-day scale. Timepoints:90 days after treatment. ; Outcome name:Criterion 1: Success in the change of the Measure of binary representation of the store scale of the National Institute of Health (bNIH), which is composed of a) Improvement of 9 or more points in the scale of NIHSS or b) Final score in the NIHSS of 0 or 1. Criterion 2: Modified rankin scale (mRS), evaluating its change from 0 to 6. Criterion 3: The Scale of the National Institute of Health (NIHSS) will evaluate the severity of cerebral infarction in 3 levels (7-10, 11-15 and 16-22). Criterion 4: The Stroke 16 Impact Scale (SIS-16). Criterion 5: Determination of the death of subjects from the randomization. Measure:Tertiary efficacy: 1) Neurological function. 2) Total improvement in the mRS scale. 3) Average value of the NIHSS. 4) SIS-16. 5) Mortality. Timepoints:Criteria 1, 3, and 5: At 30, 60 and / or 90 days. Criteria 2 and 4: At 90 days. ; Outcome name:Criterion 1: Clinical evaluation of any harmful effect, any dangerous problem for life or death caused or associated to the device under investigation. Criterion 2: Any adverse event that occurs during the procedure of using the NTS or 7 days thereafter. Criterion 3: Clinical evaluation of any harmful effect, any problem dangerous to life or death after the start of the use of the device under investigation. Measure:Security: 1) Free survival of adverse events related to the device 2) Free survival of adverse events related to the procedure. 3) Number and percentage of adverse events. Timepoints:At 90 days. | — |
Countries
Germany, Peru, Sweden, United States
Outcome results
None listed