Recruiting

Selective Dorsal Rhizotomy

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT02535936

Conditions

Spastic Diplegia

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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.

Conditions

Spastic Diplegia

Study ID

NCT02535936

Start date

Aug, 2015

Status verified date

Dec, 2024

Completion date

Jan 1, 2031

Anticipated

Primary completion date

Jan 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 18

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • No Selective Dorsal Rhizotomy surgery

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

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

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Manish N Shah, MD

713 500-7410Manish.N.Shah@uth.tmc.edu

Bangning L Yu, RN, PhD

713 500-7363Bangning.Yu@uth.tmc.edu

Locations

UTHealth & Children's Memorial Hermann Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Manish N Shah, MD

713-500-7410Manish.N.Shah@uth.tmc.edu

Bangning L Yu, RN

713 500-7363Bangning.Yu@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 11, 2024

Last verified

Dec, 2024

Keywords

  • Cerebral Palsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-12-11.