Spastic DiplegiaNCT02535936
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
A study testing 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia in people with Spastic Diplegia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Spastic Diplegia
- What is being tested?
- 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 1 Jan 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children diagnosis with Spastic Diplegia and having Selective Dorsal Rhizotomy surgery
Who cannot join
- No Selective Dorsal Rhizotomy surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UTHealth & Children's Memorial Hermann Hospital
Houston, Texas, 77030
Manish N Shah, MD, 713-500-7410, Manish.N.Shah@uth.tmc.edu
Bangning L Yu, RN, 713 500-7363, Bangning.Yu@uth.tmc.edu
About this study
The purpose of this study is to characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.
Read the detailed 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.
- Conditions
- Spastic Diplegia
- Being tested
- 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia
- Keywords
- Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesiaProcedure or surgery
2 post-operative MRI's at 2 months and 12 months
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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)
Measured: 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)
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study startAug 2015
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic DiplegiaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manish Narendra Shah, The University of Texas Health Science Center, Houston
- Investigators
- Manish N Shah, MD, Principal investigator, UTHealth Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535936
- Sponsor's protocol ID
- HSC-MS-15-0335
- Status last verified
- Dec 2024
- First submitted
- 25 Aug 2015
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- ClinicalTrials.gov ID
- NCT02535936
- Acronym / sponsor ID
- HSC-MS-15-0335
- Conditions
- Spastic Diplegia
- Keywords
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3Tesla MRI with DTI-MRI and rsfcMRI | Other | Procedure: 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesiaPatients will receive 2 post-operative MRI's with DTI and rsfcMRI at 2 months and 12 months. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children diagnosis with Spastic Diplegia and having Selective Dorsal Rhizotomy surgery
Key exclusion criteria (1 listed)
- No Selective Dorsal Rhizotomy surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia2 post-operative MRI's at 2 months and 12 months | Procedure or surgery | 3Tesla MRI with DTI-MRI and rsfcMRI |
Primary outcome
Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Time frame: Baseline and 12 months
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR).
Change in Mean Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Time frame: Baseline and 12 months
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract Selective Dorsal Rhizotomy (SDR).
Change in Radial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Time frame: Baseline and 12 months
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)
Change in Axial Diffusivity as assessed by brain MRI with diffusion tractography imaging (DTI) sequences
Time frame: Baseline and 12 months
This measure will be used to assess changes in the lower extremity fibers corticopyramidal tract after Selective Dorsal Rhizotomy (SDR)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Manish N Shah, MD principal investigator
UTHealth Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia in people with Spastic Diplegia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manish N Shah, MD (713 500-7410, Manish.N.Shah@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fractional Anisotropy as assessed by brain MRI with diffusion tractography imaging (DTI) sequences (time frame: Baseline and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.