Evaluation of Neuroinflammation in Children With Infantile Spasms

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Brief Title

Evaluation of Neuroinflammation in Children With Infantile Spasms

Official Title

Neuroinflammation in Children With Infantile Spasms Measured With 11C-PK11195 Positron Emission Tomography: Response to ACTH

Brief Summary

      The purpose of this study was to investigate the presence of neuroinflammation in children
      with infantile spasms using 11C-PK11195 positron emission tomography (PK PET) scan, and its
      response to ACTH treatment by repeating the PK PET scan after treatment.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Neuroinflammation in cortical and/or subcortical structures


Condition

Infantile Spasms

Intervention

ACTH

Study Arms / Comparison Groups

 Infantile Spasms
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

8

Start Date

March 2013

Completion Date

July 2017

Primary Completion Date

July 2016

Eligibility Criteria

        Inclusion Criteria:

          -  A clinical diagnosis of 'cryptogenic IS'

          -  Normal MRI

          -  No other neurological disorder

        Exclusion Criteria:

          -  Abnormal MRI

          -  No anti-inflammatory medication 48 hrs prior to PK PET scans

          -  Parent/guardian unable to give written consent
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02092883

Organization ID

25QNC


Responsible Party

Principal Investigator

Study Sponsor

Wayne State University


Study Sponsor

, , 


Verification Date

November 2017