Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07817745

Outcomes of Neurosurgical Tone Management

Sponsor: Boston Children's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - 25 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-06-26

Completion Date

2031-01-01

Last Updated

2026-09-14

Healthy Volunteers

No

Locations (1)

Boston Children's Hospital

Boston, Massachusetts, United States