US2014163070A1PendingUtilityA1

Treatment for cerebral palsy impaired speech in children

Assignee: ROSEMAN BRUCEPriority: May 17, 2012Filed: Feb 18, 2014Published: Jun 12, 2014
Est. expiryMay 17, 2032(~5.8 yrs left)· nominal 20-yr term from priority
A61K 31/4458A61B 5/4064A61B 5/055A61K 31/137A61B 5/4803A61K 45/06A61B 5/16
70
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Claims

Abstract

Cerebral palsy impaired speech in children and adolescents are effectively treated by administration of a psychostimulant. Low doses of the psychostimulant significantly (p=0.0025) increases the percentage of correctly pronounced intelligible syllables or words and the ability to more intelligibly communicate (p=0.0309). The improvement in speech persists after cessation of or prior to continued psychostimulant treatment.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A method for treating speech impairment secondary to cerebral palsy in a subject in need of such treatment, said method comprises:
 (a) providing a psychostimulant;   (b) administering the psychostimulant in a therapeutically effective dose to the subject;   whereby the speech impairment is improved.   
     
     
         2 . The method of  claim 1 , wherein the subject has a chronological age greater than the speech-language age equivalence prior to step (a) and the difference between the chronological age and speech language age equivalence is diminished after step (b). 
     
     
         3 . The method of  claim 1 , wherein there is a diminished difference in chronological age to speech-language age equivalence that persists after the psychostimulant is no longer efficaciously active in the subject. 
     
     
         4 . The method of  claim 1 , wherein the subject is unable to pronounce one or more of the bilabial consonants prior to step (a) and is able to pronounce the one or more bilabial consonants after step (b). 
     
     
         5 . The method of  claim 1 , wherein steps (a) and (b) are repeated periodically over a period of time and wherein the diminishment in the impaired speech continues over the period of time. 
     
     
         6 . The method of  claim 1 , wherein further comprising prior to step (a) determining the cognitive functional age of the subject through non-verbal means, and wherein the cognitive functional age is at least about two years. 
     
     
         7 . The method of  claim 1 , wherein the improved speech impairment comprises a percentage increase in correctly pronounced syllables and words of from at least about 1.2 fold to upwards of 5 fold. 
     
     
         8 . The method of  claim 1 , wherein the subject is a child or adolescent. 
     
     
         9 . The method of  claim 8 , wherein the speech impairment comprises severe dysarthric speech, and the child or adolescent prior to steps (a) and (b), has no or limited bilabial functionality, and after step (b) has improved bilabial functionality. 
     
     
         10 . The method of  claim 1  comprises a psychostimulant 
     
     
         11 . The method of  claim 1 , wherein the psychostimulant comprises an amphetamine. 
     
     
         12 . A method for evaluating a subject for the psychostimulant treatment of a speech impairment secondary to cerebral palsy, said method comprises:
 (a) diagnosing the subject as having cerebral palsy;   (b) determining the subject has a speech impairment secondary to the cerebral palsy;   (c) determining the subject has a threshold cognitive capacity; and wherein when the subject has cerebral palsy impaired speechand the threshold cognitive capacity, the subject is a candidate for psychostimulant treatment to diminish the speech impairment.   
     
     
         13 . The method of  claim 12 , step (c) further comprises determining the cognitive age of the subject, and wherein the chronological age is greater than the cognitive age. 
     
     
         14 . The method of  claim 12 , wherein the threshold cognitive capacity is at least about a 2 year old. 
     
     
         15 . The method of  claim 12 , wherein step (b) further comprises measuring the speech-language age equivalence of the subject; and wherein when the chronological age of the subject is greater than the speech-language age equivalence of the subject. 
     
     
         16 . The method of  claim 12 , wherein step (a) further comprises determining that the subject has a substantially intact frontal lobe. 
     
     
         17 . The method of  claim 16 , wherein step (a) further comprises determining that the subject has a damaged portion of the brain, and an undamaged portion extending from the substantially intact frontal lobe to the auditory cortex. 
     
     
         18 . The method of  claim 12 , wherein step (a) further comprises conducting a brain scan and determining that the subject has a substantially intact frontal lobe, a damaged portion, and an undamaged portion extending from the frontal lobe to the auditory cortex. 
     
     
         19 . The method of  claim 12 , wherein step (a) further comprises analyzing a brain scan of the subject. 
     
     
         20 . A pharmaceutical intervention for the treatment of speech impairment secondary to cerebral palsy in a subject in need of such said intervention, said pharmaceutical intervention comprises a therapeutically effective dose of a psychostimulant. 
     
     
         21 . The pharmaceutical intervention of  claim 20 , wherein the dose is administered periodically and the treatment persists after the psychostimulant is no longer efficaciously active in the body of the subject and in the absence of or prior to a subsequent dose. 
     
     
         22 . The pharmaceutical intervention of  claim 20 , wherein in the subject is a child or adolescent. 
     
     
         23 . A dosage regimen for treating cerebral palsy impaired speech in a subject comprising;
 a therapeutically effective dose of a psychostimulant that effects a alternate neural pathway in the brain; and   wherein there is at least about a 20% to several hundred per unit increase in the percent of correctly pronounced intelligible syllables or words after administration of the psychostimulant and an increase in the speech-language age equivalence of the subject.   
     
     
         24 . The dosage regimen of  claim 23 , wherein the subject is a child or adolescent. 
     
     
         25 . The dosage regimen of  claim 24 , wherein the psychostimulant comprises a methylphenidate. 
     
     
         26 . The dosage regimen of  claim 23 , wherein the increase in speech-language persists after the psychostimulant is no longer efficaciously active in the subject. 
     
     
         27 . The dosage regimen of  claim 26 , wherein the psychostimulant comprises an amphetamine. 
     
     
         28 . A method for evaluating a subject for psychostimulant treatment of a speech impairment secondary to cerebral palsy, said method comprises:
 (a) diagnosing the subject as having a speech impairment secondary to cerebral palsy; and   (b) determining the cognitive functional age of the subject, wherein the cognitive functional age is at least about 2 years, and wherein when the chronological age of the subject is greater than the cognitive functional age of the subject, the subject is determined to be a suitable subject for said treatment.   
     
     
         29 . The method of  claim 28 , wherein step (a) comprises analyzing a brain scan. 
     
     
         30 . The method of  claim 29 , wherein analyzing the brain scan comprises determining (i) a damaged portion, (ii) a substantially intact frontal lobe and (iii) an undamaged portion extending from the substantially intact frontal lobe to the auditory cortex. 
     
     
         31 . The method of  claim 28 , wherein step (b)
 comprises: Determining;   (i) in the subject that the subject is following two-step related commands; and   (ii) in a non-verbal subject determining that the subject
 is: (A) sequencing limited vocalizations; and 
 (B) sequencing the vocalizations to the rhythm of the body movements. 
   
     
     
         32 . The method of  claim 31 , wherein the speech impairment secondary to cerebral palsy comprises dysarthric speech. 
     
     
         33 . The method of  claim 32 , wherein the dysarthric speech comprises non-bilabial speech. 
     
     
         34 . A method for treating a subject having a speech impairment secondary to cerebral palsy, said method comprises:
 a) diagnosing the subject as having a speech impairment secondary to cerebral palsy;   (b) determining the cognitive functional age of the subject, wherein the cognitive functional age is at least about 2 years, and wherein when the chronological age of the subject is greater than the cognitive functional age, the subject is determined to be a suitable subject for said treatment; and   (c) administering a therapeutically effective dose of a psychostimulant to the suitable subject;   whereby the speech-language age equivalence of the subject is increased.   
     
     
         35 . The method of  claim 34 , wherein step (a) comprises analyzing a brain scan. 
     
     
         36 . The method of  claim 35 , wherein analyzing the brain scan comprises determining (i) a damaged portion, (ii) a substantially intact frontal lobe and (iii) an undamaged portion extending from the substantially intact frontal lobe to the auditory cortex. 
     
     
         37 . The method of  claim 34 , wherein the subject is a child or adolescent. 
     
     
         38 . The method of  claim 34 , wherein step (b)
 comprises: Determining;   (i) in the subject that the subject is following two-step related commands; and (ii) in a verbal subject, determining that the subject is using basic two-word combinations; and   (iii) in a non-verbal subject determining that the
 subject is: (A) sequencing limited vocalizations; and 
 (B) moving the body to a rhythm when modeled.

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