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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,962 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

Spastic Diplegia Research Study Groups: 3Tesla MRI with DTI-MRI and rsfcMRI

Spastic Diplegia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are recruitment efforts underway for this research endeavor?

"The data available on clinicaltrials.gov confirms that the study is actively searching for participants, first having been posted in August 2015 and last updated May 17th 2022."

Answered by AI

Are middle-aged individuals eligible for the research?

"As stated in the rules of enrollment, individuals aged 3 to 18 can join this clinical trial."

Answered by AI

What are the eligibility requirements for participation in this medical trial?

"To meet the entry requirements for this clinical trial, applicants must have spastic diplegia and be aged between 3 to 18 years old. As of now, 15 spots are still available."

Answered by AI

What is the participation rate of this medical experiment?

"Affirmative. Clinicaltrials.gov has the pertinent details regarding this clinical trial; it was initially listed on August 1st 2015 and updated as recently as May 17th 2022. There is a need for 15 participants at one research site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy

Manish Narendra Shah 2015. "Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02535936.

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