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Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

Primary Purpose

Spastic Diplegia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Spastic Diplegia focused on measuring Cerebral Palsy

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No Selective Dorsal Rhizotomy surgery

Sites / Locations

  • UTHealth & Children's Memorial Hermann HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

3Tesla MRI with DTI-MRI and rsfcMRI

Arm Description

Patients will receive 2 post-operative MRI's with DTI and rsfcMRI at 2 months and 12 months.

Outcomes

Primary Outcome Measures

Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
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) sequences
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) sequences
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) sequences
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)

Secondary Outcome Measures

Full Information

First Posted
August 25, 2015
Last Updated
May 17, 2022
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02535936
Brief Title
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
Official Title
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 1, 2030 (Anticipated)
Study Completion Date
January 1, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spastic Diplegia
Keywords
Cerebral Palsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
3Tesla MRI with DTI-MRI and rsfcMRI
Arm Type
Other
Arm Description
Patients will receive 2 post-operative MRI's with DTI and rsfcMRI at 2 months and 12 months.
Intervention Type
Procedure
Intervention Name(s)
3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia
Intervention Description
2 post-operative MRI's at 2 months and 12 months
Primary Outcome Measure Information:
Title
Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Description
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR).
Time Frame
Baseline and 12 months
Title
Change in Mean Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Description
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract Selective Dorsal Rhizotomy (SDR).
Time Frame
Baseline and 12 months
Title
Change in Radial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Description
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)
Time Frame
Baseline and 12 months
Title
Change in Axial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Description
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)
Time Frame
Baseline and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children diagnosis with Spastic Diplegia and having Selective Dorsal Rhizotomy surgery Exclusion Criteria: No Selective Dorsal Rhizotomy surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manish N Shah, MD
Phone
713 500-7410
Email
Manish.N.Shah@uth.tmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Bangning L Yu, RN, PhD
Phone
713 500-7363
Email
Bangning.Yu@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish N Shah, MD
Organizational Affiliation
UTHealth Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UTHealth & Children's Memorial Hermann Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manish N Shah, MD
Phone
713-500-7410
Email
Manish.N.Shah@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Bangning L Yu, RN
Phone
713 500-7363
Email
Bangning.Yu@uth.tmc.edu

12. IPD Sharing Statement

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Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

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