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Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

NCT ID: NCT02535936

Last Updated: 2024-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2031-01-01

Brief Summary

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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

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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.

Conditions

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Spastic Diplegia

Keywords

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Cerebral Palsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

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

Intervention Type PROCEDURE

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

Interventions

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

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No Selective Dorsal Rhizotomy surgery
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Manish Narendra Shah

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manish N Shah, MD

Role: PRINCIPAL_INVESTIGATOR

UTHealth Medical School

Locations

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UTHealth & Children's Memorial Hermann Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manish N Shah, MD

Role: CONTACT

Phone: 713 500-7410

Email: [email protected]

Bangning L Yu, RN, PhD

Role: CONTACT

Phone: 713 500-7363

Email: [email protected]

Facility Contacts

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Manish N Shah, MD

Role: primary

Bangning L Yu, RN

Role: backup

Other Identifiers

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HSC-MS-15-0335

Identifier Type: -

Identifier Source: org_study_id