Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

Spastic Diplegia Clinical Trial

Official title:

Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02535936
• Other study ID #: HSC-MS-15-0335
• Status: Recruiting
• Phase: N/A
• Start date: August 2015
• Est. completion date: January 1, 2031

Study information

• Verified date: May 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: Manish N Shah, MD
• Phone: 713 500-7410
• Email: Manish.N.Shah[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: January 1, 2031
• Est. primary completion date: January 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• No Selective Dorsal Rhizotomy surgery

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Spastic Diplegia

Intervention

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

Locations

Country	Name	City	State
United States	UTHealth & Children's Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 12 months
Primary	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).	Baseline and 12 months
Primary	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)	Baseline and 12 months
Primary	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)	Baseline and 12 months