Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

May 17, 2022 updated by: Manish Narendra Shah, The University of Texas Health Science Center, Houston
The purpose of this study is to characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No Selective Dorsal Rhizotomy surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 3Tesla MRI with DTI-MRI and rsfcMRI
Patients will receive 2 post-operative MRI's with DTI and rsfcMRI at 2 months and 12 months.
Procedure: 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia
2 post-operative MRI's at 2 months and 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract Selective Dorsal Rhizotomy (SDR).
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
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)
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
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)
Baseline and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Manish N Shah, MD, UTHealth Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

January 1, 2030

Study Completion (Anticipated)

January 1, 2031

Study Registration Dates

First Submitted

August 25, 2015

First Submitted That Met QC Criteria

August 28, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Actual)

May 19, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-MS-15-0335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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