RecruitingNCT07817745

Outcomes of Neurosurgical Tone Management


Sponsor

Boston Children's Hospital

Enrollment

100 participants

Start Date

Jun 26, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Patients with spastic/dystonic quadriplegia (GMFCS IV/V) are often severely disabled by their tone, and require surgical tone management to improve quality of life, allow for better function, improve comfort, and range of motion. This has historically been limited to Intrathecal Baclofen (ITB) pumps, which are effective for up to 85% of patients but carry significant morbidity / complications and are not appropriate for many patients. More recently, combined dorsal/ventral rhizotomy (CR) has emerged as an alternative means for tone control, a one-time surgery with no required hardware implantation. However, more information is needed regarding long-term outcomes of this procedure in addition to comparative outcomes of ITB. This information will lead to improved patient selection, counseling, and care. This is a prospectively enrolled, single-center study, involving survey administration and clinical observation of outcomes pre- and post-surgery.


Eligibility

Min Age: 6 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a new treatment for people with cerebral palsy (cp) and spastic/dystonic quadriplegia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 6 Years to 25 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Boston Children's Hospital

Boston, Massachusetts, United States

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NCT07817745


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