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Procedure

Selective Dorsal Rhizotomy for Cerebral Palsy

N/A
Recruiting
Led By Manish N Shah, MD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children diagnosis with Spastic Diplegia and having Selective Dorsal Rhizotomy surgery
Be younger than 65 years old
Must not have
No Selective Dorsal Rhizotomy surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at how a surgery that cuts some nerves in the spine affects brain activity in kids with a certain kind of cerebral palsy.

Who is the study for?
This trial is for children diagnosed with Spastic Diplegia, a form of Cerebral Palsy characterized by muscle spasms. Participants must be undergoing Selective Dorsal Rhizotomy surgery to qualify.
What is being tested?
The study aims to understand how brain connections change after Selective Dorsal Rhizotomy in kids with Spastic Diplegia using advanced MRI techniques under general anesthesia.
What are the potential side effects?
General anesthesia may cause side effects like nausea, vomiting, sore throat, confusion upon waking up, and rare but serious risks such as allergic reactions or breathing difficulties.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child has Spastic Diplegia and will undergo Selective Dorsal Rhizotomy surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not had Selective Dorsal Rhizotomy surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Axial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Change in Mean Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: 3Tesla MRI with DTI-MRI and rsfcMRIExperimental Treatment1 Intervention
Patients will receive 2 post-operative MRI's with DTI and rsfcMRI at 2 months and 12 months.

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,845 Total Patients Enrolled
Manish N Shah, MDPrincipal InvestigatorUTHealth Medical School

Media Library

3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02535936 — N/A
Cerebral palsy Research Study Groups: 3Tesla MRI with DTI-MRI and rsfcMRI
Cerebral palsy Clinical Trial 2023: 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia Highlights & Side Effects. Trial Name: NCT02535936 — N/A
3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02535936 — N/A
~5 spots leftby Jan 2030
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