Outcomes of Neurosurgical Tone Management

ClinicalTrials.gov ID: NCT07817745

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ClinicalTrials.gov public records Last synced Nov 15, 2026, 9:31 AM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07817745
Recruitment status: Recruiting
Study type: Observational
Phase: Not listed
Lead sponsor: Boston Children's Hospital; Other
Enrollment: 100 participants

Conditions and interventions

Conditions

Interventions

Not listed

Eligibility (public fields only)

Age range: 6 Years to 25 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jun 26, 2024 (Actual)
Primary completion: Jul 1, 2030 (Estimated)
Completion: Jan 1, 2031 (Estimated)
Last update posted: Sep 14, 2026

2024 – 2031

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Boston Children's Hospital	Boston	Massachusetts	02115	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07817745, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Sep 14, 2026 · Synced Nov 15, 2026