Multiple Sclerosis Clinical Trial

Long-term Outcomes of Selective Dorsal Rhizotomy Among Individuals With Cerebral Palsy

Summary

Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Selective dorsal rhizotomy (SDR) is a surgical method used by some hospitals to permanently reduce spasticity in order to prevent further morbidities. Better understanding of the long-term outcomes of SDR is essential for clinicians and families. The results of this study will have direct clinical impact by equipping providers with the necessary information to counsel families during medical decision making.

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Full Description

Spasticity affects up to 80% of individuals diagnosed with cerebral palsy. Excessive spasticity is thought to be uncomfortable, reduce function, cause gait deviations (e.g. equinus), and contribute toward musculoskeletal deformity and an elevated energy cost while walking. As such, SDR is a surgical method used by some hospitals to permanently reduce spasticity in order to prevent the aforementioned morbidities.

Treatment philosophies differ widely in regards to how aggressively to manage spasticity. Some centers (e.g. Gillette) aggressively treat spasticity early in life through a variety of measures such as SDR, intrathecal baclofen pumps, and botulinum toxin injections. Other centers (e.g. Shriners Hospitals for Children - Salt Lake City and Spokane) offer little in the way of spasticity reduction treatments.

There are several compelling reasons to conduct the proposed research study. First, emerging evidence suggests that the elimination of spasticity during childhood via SDR does not prevent contractures and only partially explains poor gross motor function, both previously thought to be clear outcomes of the surgery. Additionally, many of the longitudinal cohort studies that examined SDR outcomes have shown many outcome measures peak 1-3 years after surgery, and then decline toward baseline (i.e. pre-SDR) levels. Lastly, the quality of the SDR outcome literature is poor. Rarely are outcomes looked at in context of a proper control group. Either a control group is absent or comprised of typically developing children. This limits our ability to understand how patients with cerebral palsy may age without undergoing an SDR.

Better understanding of the long-term outcomes of SDR is essential for clinicians and families. The surgery, in general, is costly to families (time, expense, risk, etc.) and clinicians should have every confidence in the intended outcomes for any intervention.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria for Controls (-SDR) and Cases (+SDR):

Able to speak and read English
Diagnosed with bilateral cerebral palsy (i.e. no hemiplegics)
Minimum age of 21 years presently
Had a baseline gait and motion analysis

Controls (-SDR):

No SDR
No history of intrathecal baclofen (ITB) pump implantation for > 1 year
No ITB pump at time of long-term follow-up (explant > or = 6 months)
No history of oral baclofen for > 1 year
No oral baclofen use at time of long-term follow-up
No more than 10 sessions on botulinum toxin, phenol, or alcohol injection

Cases (+SDR):

History of SDR > 5 years ago
Had a baseline gait analysis < or = 18 months before SDR

Exclusion Criteria:

none

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

78

Study ID:

NCT03789786

Recruitment Status:

Completed

Sponsor:

Gillette Children's Specialty Healthcare

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There are 3 Locations for this study

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Gillette Children's Specialty Healthcare
Saint Paul Minnesota, 55101, United States
Shriners Hospitals for Children - Salt Lake City
Salt Lake City Utah, 84103, United States
Shriners Hospitals for Childrens - Spokane
Spokane Washington, 99204, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

78

Study ID:

NCT03789786

Recruitment Status:

Completed

Sponsor:


Gillette Children's Specialty Healthcare

How clear is this clinincal trial information?

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