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US-20260124234-A1 - METHOD FOR TREATING A NEUROLOGICAL DISORDER IN AN ANIMAL

US20260124234A1US 20260124234 A1US20260124234 A1US 20260124234A1US-20260124234-A1

Abstract

A method for treating a neurological disorder in an animal. A chitosan Fragmented Physical Hydrogel Suspension (C fphs ) is administered to the animal at a site of spinal cord injury (SCI). Thereafter both (1) cerebral cortex neuromodulation and (2) spinal cord direct current stimulation (tsDCS) are performed on the animal.

Inventors

  • John H. Martin
  • Fatiha Nothias-Chahir

Assignees

  • RESEARCH FOUNDATION OF THE CITY UNIVERSITY OF NEW YORK
  • CENTRE NATIONAL DE LA RECHERCHE SCIENTIFIQUE

Dates

Publication Date
20260507
Application Date
20251008

Claims (15)

  1. 1 . A method for treating a neurological disorder in an animal, the method comprising steps of: administering chitosan Fragmented Physical Hydrogel Suspension (C fphs ) to the animal at a site of spinal cord injury (SCI); performing both (1) cerebral cortex neuromodulation and (2) spinal cord direct current stimulation (tsDCS) on the animal for at least 10 minutes per day; and repeating the step of performing for at least 10 days.
  2. 2 . The method as recited in claim 1 , wherein the step of performing is performed for at least 20 minutes per day.
  3. 3 . The method as recited in claim 1 , wherein the step of performing is performed for at least 28 minutes per day.
  4. 4 . The method as recited in claim 1 , wherein the step of performing is performed for less than 1 hour per day.
  5. 5 . The method as recited in claim 1 , wherein the at least 10 days are 10 sequential days.
  6. 6 . The method as recited in claim 1 , wherein the cerebral cortex neuromodulation is motor cortex (MCX) neuromodulation.
  7. 7 . The method as recited in claim 1 , wherein the step of administering is performed within 56 days of an injury to the site of spinal cord injury (SCI).
  8. 8 . The method as recited in claim 1 , wherein the step of administering is performed within 5 days of an injury to the site of spinal cord injury (SCI).
  9. 9 . A method for treating a neurological disorder in an animal, the method comprising steps of: administering chitosan Fragmented Physical Hydrogel Suspension (C fphs ) to the animal at a site of spinal cord injury (SCI), wherein the C fphs comprises chitosan hydrogel microparticles with a median size d50, obtained from a number distribution, of from 1 to 500 μm, a degree of acetylation of less than or equal to 20%, wherein chitosan in the hydrogel microparticles is from 0.25 to 5% concentration by weight, based on the total weight of the C fphs ; performing both (1) motor cortex (MCX) neuromodulation and (2) spinal cord direct current stimulation (tsDCS) on the animal for at least 10 minutes per day; and repeating the step of performing for at least 10 days.
  10. 10 . The method as recited in claim 9 , wherein the step of performing is performed for at least 20 minutes per day.
  11. 11 . The method as recited in claim 9 , wherein the step of performing is performed for at least 28 minutes per day.
  12. 12 . The method as recited in claim 9 , wherein the step of performing is performed for less than 1 hour per day.
  13. 13 . The method as recited in claim 9 , wherein the at least 10 days are 10 sequential days.
  14. 14 . The method as recited in claim 9 , wherein the step of administering is performed within 56 days of an injury to the site of spinal cord injury (SCI).
  15. 15 . The method as recited in claim 9 , wherein the step of administering is performed within 5 days of an injury to the site of spinal cord injury (SCI).

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to, and is a non-provisional of, U.S. Patent Applications 63/704,770 (filed Oct. 8, 2024) and 63/894,367 (filed Oct. 6, 2025), the entirety of which is incorporated herein by reference. STATEMENT OF FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT This invention was made with Government support under grant number 1R21NS116550 awarded by the National Institutes of Health. The government has certain rights in the invention. BACKGROUND OF THE INVENTION The subject matter disclosed herein relates to treatments for neurological damage and to treatments for spinal cord injury (SCI) in particular. SCI produces extensive damage at the trauma site, leading to neural cell loss, axon injury, and cystic cavitation. Combined injury site damage and interruption of ascending, descending and local axons produces motor, sensory, and autonomic impairments. Several factors contribute to the complexity of SCI physiopathology including breakdown of the blood-spinal cord barrier, inflammation spread, free radicals and glutamate excitotoxicity—limiting spontaneous repair. The initial trauma leads to secondary structural damage that spreads to adjacent spinal segments, characterized by axon dieback, demyelination and neural cell death. This is largely due to persistent inflammation enlarging the lesion caudally and rostrally. The developing cavities become walled off by the astrocytic scar, creating a physical-chemical barrier to axon growth, in addition to potent growth inhibitory factors (e.g., myelin debris and chondroitin sulfate proteoglycans). The progressive damage at the injury site expands the loss of neural connections with associated functional consequences. Although a variety of treatment methods have been tested, they remain limited in their ability to achieve synergistically both tissue repair and promoting projections for adequate neuronal connectivity. Alternative treatment mods are therefore desirable. The discussion above is merely provided for general background information and is not intended to be used as an aid in determining the scope of the claimed subject matter. SUMMARY A method for treating a neurological disorder in an animal. A chitosan Fragmented Physical Hydrogel Suspension (Cfphs) is administered to the animal at a site of spinal cord injury (SCI). Thereafter both (1) cerebral cortex neuromodulation and (2) spinal cord direct current stimulation (tsDCS) are performed on the animal. An advantage that may be realized in the practice of some disclosed embodiments of the method is that corticospinal tract (CST) gray matter axon density is significantly enhanced. This only occurred when the combined Cfphs and neuromodulation treatment is performed. Furthermore, when only the neuromodulation treatment is performed, only 12.5% axon growth was found below the lesion (see Exp Neurol. 2017 November; 297: 179-189). In contrast, when the combined Cfphs and neuromodulation treatment is performed, axon growth increases two-fold. In a first embodiment, a method for treating a neurological disorder in an animal is provided. The method comprising steps of: administering chitosan Fragmented Physical Hydrogel Suspension (Cfphs) to the animal at a site of spinal cord injury (SCI); performing both (1) cerebral cortex neuromodulation and (2) spinal cord direct current stimulation (tsDCS) on the animal for at least 10 minutes per day; and repeating the step of performing for at least 10 days. In a second embodiment, a method for treating a neurological disorder in an animal is provided. The methods comprising steps of: administering chitosan Fragmented Physical Hydrogel Suspension (Cfphs) to the animal at a site of spinal cord injury (SCI), wherein the Cfphs comprises chitosan hydrogel microparticles with a median size d50, obtained from a number distribution, of from 1 to 500 μm, a degree of acetylation of less than or equal to 20%, wherein chitosan in the hydrogel microparticles is from 0.25 to 5% concentration by weight, based on the total weight of the Cfphs; performing both (1) motor cortex (MCX) neuromodulation and (2) spinal cord direct current stimulation (tsDCS) on the animal for at least 10 minutes per day; and repeating the step of performing for at least 10 days. This brief description of the invention is intended only to provide a brief overview of subject matter disclosed herein according to one or more illustrative embodiments and does not serve as a guide to interpreting the claims or to define or limit the scope of the invention, which is defined only by the appended claims. This brief description is provided to introduce an illustrative selection of concepts in a simplified form that are further described below in the detailed description. This brief description is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used as an aid in determining the scope of the claimed subj