Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

This study is looking at how the brain changes in children with spastic diplegia (a type of cerebral palsy affecting leg movement) after they have Selective Dorsal Rhizotomy surgery. Researchers want to understand how the connections in the brain's outer layer (cortex) are affected by this surgery. You might be able to join if you are between 3 and 18 years old, have spastic diplegia, and are having Selective Dorsal Rhizotomy surgery. The study will measure changes in specific brain imaging markers (Fractional Anisotropy, Mean Diffusivity, and Radial Diffusivity) using special MRI scans at the beginning and 12 months after surgery to see if the surgery changes brain structure. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 15 participants. It is not specified if it is randomized or blinded.
What's involved
You would undergo two 3Tesla MRI scans with DTI-MRI and rsfcMRI under general anesthesia, at 2 months and 12 months after your surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after their surgery, with the final MRI scan at that time.

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NCT02535936

Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

Recruiting
NAAges 3–18InterventionalDiagnostic
The University of Texas Health Science Center, Houston
~15 participants
Updated 2024-12-11 on ClinicalTrials.gov
What's tested:3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Measured over Baseline and 12 months
+3 more outcomes measured
Spastic Diplegia
1 sites across 1 states
Texas1
  • Manish N Shah, MD · PRINCIPAL_INVESTIGATOR · UTHealth Medical School

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Eligibility criteria

Inclusion

Children diagnosis with Spastic Diplegia and having Selective Dorsal Rhizotomy surgery

Exclusion

No Selective Dorsal Rhizotomy surgery
  • Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequencesBaseline and 12 months

    This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR).

  • Change in Mean Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequencesBaseline and 12 months

    This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract Selective Dorsal Rhizotomy (SDR).

  • Change in Radial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequencesBaseline and 12 months

    This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)

  • Change in Axial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequencesBaseline and 12 months

    This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)