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Recruiting NCT02535936

Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

No phase Interventional Spastic Diplegia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia.
Who it may be relevant to
Registry conditions: Spastic Diplegia. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The purpose of this study is to characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.

Detailed description

To establish the structural changes in the corticopyramidal tract using diffusion tractography imaging (DTI) due to selective dorsal rhizotomy and compare the resting state functional connectivity(rsfcMRI) temporal latency differences of spastic diplegics for Selective Dorsal Rhizotomy.

Interventions

  • Procedure 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia
    2 post-operative MRI's at 2 months and 12 months

Primary outcome measures

  • Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences [Time frame: Baseline and 12 months]
  • Change in Mean Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences [Time frame: Baseline and 12 months]
  • Change in Radial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences [Time frame: Baseline and 12 months]
  • Change in Axial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences [Time frame: Baseline and 12 months]

Eligibility criteria

Inclusion criteria

  • Children diagnosis with Spastic Diplegia and having Selective Dorsal Rhizotomy surgery

Exclusion criteria

  • No Selective Dorsal Rhizotomy surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • UTHealth & Children's Memorial Hermann Hospital — Houston

Identifiers

NCT: NCT02535936 · HSC-MS-15-0335

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗