Selective Dorsal Rhizotomy for Cerebral Palsy

Overseen By Manish N Shah, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: No surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to characterize the cortical connectivity changes in the brain of spastic diplegic children after Selective Dorsal Rhizotomy.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Selective Dorsal Rhizotomy for Cerebral Palsy?

Research shows that Selective Dorsal Rhizotomy (SDR) can reduce spasticity (muscle stiffness) in children with cerebral palsy, and long-term studies indicate improvements in gross motor function, pain, and quality of life years after the procedure. ^{1 2 3 4 5}

Is it safe to undergo MRI with general anesthesia for cerebral palsy?

Research indicates that MRI scans, even with general anesthesia, can be performed safely in patients with cerebral palsy, as long as proper monitoring and precautions are taken. Studies have shown that MRI-related procedures, including those with deep brain stimulation devices, do not result in significant adverse events when safety guidelines are followed. ^{6 7 8 9 10}

How is the 3-Tesla MRI with DTI-MRI and rsfcMRI treatment for cerebral palsy different from other treatments?

The 3-Tesla MRI with DTI-MRI and rsfcMRI treatment is unique because it uses advanced imaging techniques to assess brain connectivity and structure under general anesthesia, which may provide detailed insights into the brain's function and help tailor interventions for cerebral palsy, unlike traditional treatments that focus solely on reducing spasticity through surgery or medication. ^{2 4 11 12 13}

Research Team

Manish N Shah, MD

Principal Investigator

UTHealth Medical School

Eligibility Criteria

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.

Inclusion Criteria

My child has Spastic Diplegia and will undergo Selective Dorsal Rhizotomy surgery.

Exclusion Criteria

I have not had Selective Dorsal Rhizotomy surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Intervention

Participants undergo Selective Dorsal Rhizotomy surgery

1 week

Post-operative MRI Assessments

Participants receive 2 post-operative MRI's with DTI and rsfcMRI at 2 months and 12 months

12 months

2 visits (in-person)

Follow-up

Participants are monitored for changes in cortical connectivity and corticopyramidal tract

12 months

Treatment Details

Interventions

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

Trial Overview 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.

Participant Groups

Group I: 3Tesla MRI with DTI-MRI and rsfcMRI Experimental Treatment 1 Intervention

Patients will receive 2 post-operative MRI's with DTI and rsfcMRI at 2 months and 12 months.

3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia is already approved in United States, European Union, Japan, Canada for the following indications:

Approved in United States as 3-Tesla MRI with DTI-MRI and rsfcMRI for:

• Diagnostic imaging for neurological conditions

Approved in European Union as 3T MRI with diffusion tensor imaging and resting-state functional connectivity MRI for:

• Diagnostic imaging for neurological conditions

Approved in Japan as 3-Tesla MRI with DTI-MRI and rsfcMRI for:

• Diagnostic imaging for neurological conditions

Approved in Canada as 3T MRI with diffusion tensor imaging and resting-state functional connectivity MRI for:

• Diagnostic imaging for neurological conditions

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Findings from Research

The study used diffusion tensor imaging (DTI) to identify significant radiological differences in the corticospinal tract (CST) between quadriplegic cerebral palsy patients (QCP), diplegic cerebral palsy patients (DCP), and normal controls, highlighting the potential of DTI in assessing cerebral palsy.

QCP patients exhibited decreased fractional anisotropy (FA) and increased apparent diffusion coefficient (ADC) values in the CST compared to DCP and normal controls, indicating that DTI results align with the clinical manifestations of different types of cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diffusion tensor imaging demonstrated radiologic differences between diplegic and quadriplegic cerebral palsy. Chang, MC., Jang, SH., Yoe, SS., et al.[2022]

In a study of 38 patients with cerebral palsy undergoing single-level selective dorsal rhizotomy (SDR), it was found that ventral roots activated more muscles at lower stimulus thresholds compared to dorsal roots, indicating a clear physiological distinction that can guide surgical procedures.

The study established that approximately 64.72% of each rootlet was transected during SDR, and emphasized the need for individualized treatment plans due to variability in physiological responses among patients, including some with abnormal response characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiology of Sensory and Motor Nerve Root Fibers in Selective Dorsal Rhizotomies. Martinez, V., Browd, S., Osorio, M., et al.[2020]

In a study of 36 children with bilateral spastic paresis, those with normal MRI results showed the best improvement in gross motor function after selective dorsal rhizotomy (SDR), while those with hydrocephalus had minimal improvements.

The severity of periventricular leucomalacia (PVL) correlated with pre-surgery gross motor function scores but did not predict the functional outcomes after SDR, indicating that MRI characteristics can influence expected recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preoperative MRI findings and functional outcome after selective dorsal rhizotomy in children with bilateral spasticity. Grunt, S., Becher, JG., van Schie, P., et al.[2021]

In a study of 140 children with cerebral palsy undergoing selective dorsal rhizotomy (SDR), obesity was identified as a significant predictor of complications, including prolonged wound healing and superficial surgical site infections, with a notable odds ratio of 24.4 for wound healing issues.

The study found that while SDR is generally safe across all Gross Motor Functional Classification System (GMFCS) levels, non-ambulatory children (GMFCS IV and V) were more likely to require extended epidural pain management, highlighting the need for careful monitoring in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of postoperative complications after selective dorsal rhizotomy. Wach, J., Yildiz, ÖC., Sarikaya-Seiwert, S., et al.[2021]

Selective dorsal rhizotomy (SDR) in children with bilateral spastic cerebral palsy showed sustained reduction in muscle tone for up to 17 years post-surgery, but did not lead to long-term improvements in gross motor function or prevent contractures.

While SDR did not enhance overall physical functioning, it may help reduce pain levels in individuals with cerebral palsy, as half of the participants reported low-intensity pain and interference after the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective cohort study investigating gross motor function, pain, and health-related quality of life 17 years after selective dorsal rhizotomy in cerebral palsy. Tedroff, K., Löwing, K., Åström, E.[2022]

In a study of 102 participants with active deep brain stimulation (DBS) systems, no short- or long-term adverse events were reported during MRI scans at both 1.5 T and 3 T, indicating that DBS patients can safely undergo MRI procedures.

While DBS hardware caused some imaging artifacts, these only obscured a small portion of the brain (1.4% at 1.5 T and 2.1% at 3 T), primarily affecting areas near the electrode contacts, which suggests that MRI can still provide useful information in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional MRI Safety and Artifacts during Deep Brain Stimulation: Experience in 102 Patients. Boutet, A., Rashid, T., Hancu, I., et al.[2020]

A study involving 47 infants under 3 months old demonstrated that brain MRI can be successfully performed without general anesthesia, achieving a success rate of 89% in the imaging studies.

The technique, which involved feeding infants to induce sleep and using an immobilizing pillow, was found to be safe with no reported safety issues, and it helped avoid the risks associated with anesthesia in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain MRI without anesthesia in children less than 3 months old. Caro-Domínguez, P., Sánchez-Garduño, JJ., Martínez-Moya, M., et al.[2021]

A study involving 47 infants under 3 months old demonstrated that brain MRI can be successfully performed without general anesthesia, achieving a success rate of 89% in the imaging studies.

The 'feed and sleep' technique, combined with immobilization using a pillow, was safe and resulted in no safety issues, allowing for effective imaging while avoiding the risks associated with anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain MRI without anesthesia in children less than 3 months old. Caro-Domínguez, P., Sánchez-Garduño, JJ., Martínez-Moya, M., et al.[2022]

A 65-year-old man with athetoid cerebral palsy successfully underwent an MRI of the cervical spine under general anesthesia, highlighting the need for careful management in patients with involuntary movements.

The procedure was uneventful, demonstrating that with appropriate monitoring and airway management, MRI scans under general anesthesia can be safely performed, even though such cases are rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Case of General Anaesthesia Using an I-gel Airway for MRI of an Adult Patient With Athetoid Cerebral Palsy. Takechi, K., Yamashita, A., Shimizu, I.[2023]

Functional MRI (fMRI) can be safely performed in human subjects with fully implanted deep brain stimulation (DBS) systems, as temperature changes during typical MRI sequences were within safe limits, showing no significant risk of overheating.

The study found that even at higher specific absorption rates (SARs), the temperature increases were still manageable, indicating that DBS equipment performance is minimally affected during fMRI, thus reducing the likelihood of experimental confounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional MRI with active, fully implanted, deep brain stimulation systems: safety and experimental confounds. Carmichael, DW., Pinto, S., Limousin-Dowsey, P., et al.[2022]

In a study of 145 children undergoing selective dorsal rhizotomy (SDR) for spastic cerebral palsy, the authors developed a robust electrophysiological technique to accurately identify and guide the division of afferent nerve roots, which is crucial for reducing spasticity.

No new motor or sphincter deficits were observed post-surgery, indicating that the technique effectively spares important nerve functions while achieving the desired therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative electrophysiology during single-level selective dorsal rhizotomy: technique, stimulation threshold, and response data in a series of 145 patients. De Vloo, P., Huttunen, TJ., Forte, D., et al.[2020]

Selective dorsal rhizotomy significantly alleviates spasticity in children with cerebral palsy, as evidenced by improved knee and hip ranges of motion that approached normal limits after 10 years.

The study, which involved 11 children with spastic diplegia and used quantitative gait analysis over a long-term follow-up, demonstrated lasting functional benefits in gait, although step length and velocity remained below normal levels after a decade.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait before and 10 years after rhizotomy in children with cerebral palsy spasticity. Subramanian, N., Vaughan, CL., Peter, JC., et al.[2022]

Selective dorsal rhizotomy (SDR) effectively reduces lower extremity spasticity in cerebral palsy, and in one patient, it led to a significant enhancement of the hand sensory representation in the brain after the procedure.

In two other patients, SDR did not cause extensive reorganization of the upper limb sensory cortex, indicating that while SDR alleviates spasticity, it may not significantly alter cortical representation for those without upper limb involvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hand somatosensory cortex activity following selective dorsal rhizotomy: report of three cases with fMRI. Ojemann, JG., McKinstry, RC., Mukherjee, P., et al.[2018]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Diffusion tensor imaging demonstrated radiologic differences between diplegic and quadriplegic cerebral palsy. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Electrophysiology of Sensory and Motor Nerve Root Fibers in Selective Dorsal Rhizotomies. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Preoperative MRI findings and functional outcome after selective dorsal rhizotomy in children with bilateral spasticity. [2021]

4. Austria pubmed.ncbi.nlm.nih.gov

Predictors of postoperative complications after selective dorsal rhizotomy. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A prospective cohort study investigating gross motor function, pain, and health-related quality of life 17 years after selective dorsal rhizotomy in cerebral palsy. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Functional MRI Safety and Artifacts during Deep Brain Stimulation: Experience in 102 Patients. [2020]

7. Spain pubmed.ncbi.nlm.nih.gov

Brain MRI without anesthesia in children less than 3 months old. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

Brain MRI without anesthesia in children less than 3 months old. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

A Case of General Anaesthesia Using an I-gel Airway for MRI of an Adult Patient With Athetoid Cerebral Palsy. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Functional MRI with active, fully implanted, deep brain stimulation systems: safety and experimental confounds. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Intraoperative electrophysiology during single-level selective dorsal rhizotomy: technique, stimulation threshold, and response data in a series of 145 patients. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Gait before and 10 years after rhizotomy in children with cerebral palsy spasticity. [2022]

13. Germany pubmed.ncbi.nlm.nih.gov

Hand somatosensory cortex activity following selective dorsal rhizotomy: report of three cases with fMRI. [2018]