FIRST Site Planning

We have reached a next milestone in our resubmission for Functional Improvements Related to Spasticity Treatments (FIRST) to NIH on July 18. We need to (re)collect preliminary data from each of your sites to plan the study budget and enrollment. Please download this document which describes the inclusion / exclusion criteria in the form below. Please fill in the form using chart review or whatever tracking mechanisms you use for your SDR case load for the calendar years 2018 and 2019 (intentionally pre-COVID). For the matched controls, please comment on your anticipated ability to enroll controls matching these criteria 2:1 with each patient enrolled for an SDR.

FIRST Site Preliminary Data
IMPORTANT NOTE:

The inclusion criteria for this study has changed from the first submission. Please use the following inclusion / exclusion criteria for children that received SDRs at your institution for you answers.

Inclusion:

  • Ages <18 years old
  • GMFCS I-III
  • Primary Movement Disorder: Spastic
  • Topography: Bilateral

Exclusion:

  • Unilateral or hemiplegic cerebral palsy
  • Hereditary or Suspected Hereditary causes of cerebral palsy (i.e. Hereditary Spastic Paraparesis)
  • Spinal causes of cerebral palsy (i.e. spinal cord injury, transverse myelitis)
  • Traumatic Brain Injury
  • Brain tumors
  • Developmental brain lesion (i.e. lissencephaly, polymicrogyria)
  • Drowning
  • Congenital or postnatal infectious etiology
Do you believe your site would be able to enroll two (2) control patients matched for GMFCS and spastic movement for each child <= 8 years old receiving an SDR?
Do you believe your site would be able to enroll two (2) control patients matched for GMFCS and spastic movement for each child <= 8 years old receiving an SDR?
Does your site use the GMFM annually to assess children with CP?
Does your site use the GMFM as a pre and post measure prior to SDR?