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Amantadine in Treating Cognitive & Motor Impairments in Adolescents and Adults With Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT04273737
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Heakyung Kim, Columbia University

Brief Summary:
Cerebral palsy (CP) is a common childhood-onset disability associated with motor and cognitive impairments, however most research is focused on motor outcomes. The aim of this study is to determine the effects of Amantadine, a dopaminergic agonist, on cognitive function in adolescents and adults with CP.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: Amantadine Hydrochloride Phase 4

Detailed Description:
CP is a heterogeneous condition due to injury to the developing brain. It is a condition that is often marked by both cognitive and motor disorders as well as increased prevalence of depression and anxiety. While most studies have focused on improving motor dysfunction, fewer have investigated cognitive impairments associated with CP. Dedicating a study to research the pharmacotherapeutic effect of Amantadine on cognitive function in adolescents and adults with cerebral palsy fills an important gap in development of a potential innovative treatment for cognitive deficits. The investigators hope to determine the effects of Amantadine on cognitive function in adolescents and adults with CP. The investigators will also evaluate secondary goals of improving gross and fine motor skills and mood.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of Amantadine in Treating Cognitive and Motor Impairments in Adolescents and Adults With Cerebral Palsy
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Amantadine
Daily regimen of amantadine hydrochloride tablets for 6 weeks: dosing of 5mg/kg divided by two daily doses (max daily dose of 300 mg)
Drug: Amantadine Hydrochloride
6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
Other Names:
  • Symmetrel
  • Symadine
  • Osmolex ER
  • Gocovri




Primary Outcome Measures :
  1. Change in Oral Symbol-Digit Modalities Test Score [ Time Frame: Baseline and 6 weeks ]

    The Symbol Digit Modalities Test (SDMT) detects cognitive impairment in less than 5 minutes. This simple, economical test is an ideal way for busy clinicians to screen for organic cerebral dysfunction in both children (8 years and older) and adults.The final score is the correct number of substitutions in 90 seconds, and scores range between 0 and 110. A lower score indicates greater cognitive impairment (worse outcome).

    Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.


  2. Change in Stroop Test Score [ Time Frame: Baseline and 6 weeks ]

    The Stroop Color and Word Test (SCWT) is a neuropsychological test. It assesses the ability to inhibit cognitive interference, which occurs when the processing of a stimulus feature affects the simultaneous processing of another attribute of the same stimulus.

    Subjects are required to read three different tables as fast as possible in 45 seconds. For the first two, participants are required to read names of colors printed in black ink (W) and name different color patches (C). In the third, color-words (CW) are printed in an inconsistent color ink (for instance the word "red" is printed in green ink). Participants are required to name the color of the ink instead of reading the word.

    Interference score (IG) = CW - [(W × C)/(W + C)]

    A greater IG score indicates a higher ability to inhibit cognitive interference (better outcome).

    Word, color, and color-word T-Scores above 40 or are considered "normal", while below 40 is considered "low".


  3. Change in Controlled Oral Word Association Test (COWAT) Score [ Time Frame: Baseline and 6 weeks ]

    The Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency and is a subtest of the Multilingual Aphasia Examination. The COWAT uses the three letter set of C, F, and L to assess phonemic fluency. Individuals are given 1 minute to name as many words as possible beginning with one of the letters. The procedure is then repeated for the remaining two letters.

    The higher the overall score, or number of words listed for each letter, the better their ability to retrieve specific information.


  4. Change in Montreal Cognitive Assessment (MoCA) Score [ Time Frame: Baseline and 6 weeks ]

    The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuo-constructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes.

    The total possible score is 30 points and can range from 0 to 30; a score of 26 or above is considered normal (high score is a better outcome).

    Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.



Secondary Outcome Measures :
  1. Change in PHQ-9 Score [ Time Frame: Baseline and 6 weeks ]

    The Patient Health Questionnaire (PHQ-9) is a self-administered, nine-item depression scale of the patient health questionnaire. The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV.

    The PHQ-9 is the depression module, which scores each of the 9 DSM-IV criteria as "0" (not at all) to "3" (nearly every day). Total scores can range from 0 to 27.

    A total score of 0-4 indicates minimal depression severity, 5-9 indicates mild depression severity, 10-14 indicates moderate depression severity, 15-19 indicates moderately severe, 20-27 indicates severe depression severity. Therefore, a high score indicates a worse outcome.

    Outcome measures will be assessing a change in scores pre- and post- prescription of Amantadine.




Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Cerebral Palsy

Exclusion Criteria:

  • Currently pregnant
  • Unstable seizure condition
  • Currently taking methadone
  • Currently taking other dopamine agonists
  • Currently taking anti-psychotic medication
  • Previously taken amantadine
  • Diagnosed with Chronic Kidney Disease (CKD)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04273737


Contacts
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Contact: Heakyung Kim, MD 212-342-1395 hk2641@cumc.columbia.edu
Contact: Nancy Lee, MS 212-305-9416 nl2674@cumc.columbia.edu

Locations
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United States, New York
Columbia Irving Medical Center Recruiting
New York, New York, United States, 10032
Contact: Heakyung Kim, MD    212-342-1395    hk2641@cumc.columbia.edu   
Contact: Nancy Lee, MS    212-305-9416    nl2674@cumc.columbia.edu   
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Heakyung Kim, MD Columbia Irving Medical Center
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Responsible Party: Heakyung Kim, Professor of Rehabilitation and Regenerative Medicine and Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT04273737    
Other Study ID Numbers: AAAS1907
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Heakyung Kim, Columbia University:
cerebral palsy
amantadine
cognitive function
gross motor skills
fine motor skills
mood
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Antiviral Agents
Anti-Infective Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents