NCT02535936

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
57mo left

Started Aug 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Aug 2015Jan 2031

Study Start

First participant enrolled

August 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

14.4 years

First QC Date

August 25, 2015

Last Update Submit

December 5, 2024

Conditions

Spastic Diplegia

Keywords

Cerebral Palsy

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (1)

3Tesla MRI with DTI-MRI and rsfcMRI

OTHER

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

Interventions

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

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

3Tesla MRI with DTI-MRI and rsfcMRI

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • No Selective Dorsal Rhizotomy surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTHealth & Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

NeuroimagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Manish N Shah, MD

    UTHealth Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Manish N Shah, MD

CONTACT

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

Bangning L Yu, RN, PhD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2015

First Posted

August 31, 2015

Study Start

August 1, 2015

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2031

Last Updated

December 11, 2024

Record last verified: 2024-12

Locations

US(1)