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NCT Number: NCT02535936

Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

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

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Key information

Conditions

Spastic Diplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No Selective Dorsal Rhizotomy surgery

Treatment and study plan

3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia

Procedure

2 post-operative MRI's at 2 months and 12 months

Primary outcomes

  1. Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences

    Time frame: Baseline and 12 months

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

  2. Change in Mean Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences

    Time frame: Baseline and 12 months

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

  3. Change in Radial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences

    Time frame: Baseline and 12 months

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

  4. Change in Axial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences

    Time frame: Baseline and 12 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Bangning L Yu, RN, PhD

CONTACT

[email protected]

713 500-7363

Manish N Shah, MD

CONTACT

[email protected]

713 500-7410

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Important dates

Study start
2015
Primary completion
2030
Study completion
2031
First posted
Aug 31, 2015
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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