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NCT Number: NCT07817745

Outcomes of Neurosurgical Tone Management

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.

Recruiting

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Key information

Conditions

Spastic/Dystonic Quadriplegia Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Cerebral Palsy (CP) Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Adam Porter, MPH

CONTACT

[email protected]

617-919-6013

Carley Vuillermin, MBBS, MPH, FRACS

SUB_INVESTIGATOR

Juliani Mariani, MD

SUB_INVESTIGATOR

Kristin Buxton, PNP

SUB_INVESTIGATOR

Scellig Stone, MD, PhD

SUB_INVESTIGATOR

Weston Northam, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patients undergoing intrathecal baclofen pump insertion or combined dorsal ventral rhizotomy at Boston Children's Hospital.
  • Must be at least 6 years of age at time of enrollment

Exclusion criteria

-

Treatment and study plan

Primary outcomes

  1. Improved Spasticity Score

    Time frame: From enrollment to 5 years

    We will study changes in Spasticity using the Modified Ashworth Scale in participants over the course of this study.

  2. Improved Dystonia Score

    Time frame: From enrollment to 5 years.

    We will use the Barry Albright Dystonia Scale to measure changes in dystonia in participants over the course of this study.

Secondary outcomes

  1. Overall Quality of Life Improvements

    Time frame: From enrollment to 5 years

    We will use the CP-Child survey to measure quality of life changes in participants over the course of this study. Specifically looking at trends in caregiver satisfaction with hygiene, and comfort.

  2. Reduced Surgical Complications

    Time frame: From enrollment to 5 years.

    We will review outcomes for our participants to quantify surgical complications such as infection, malfunction, re-operation, spinal fluid leak, prolonged urinary retention, muscle wasting, and decubitus ulcer formation.

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Porter, Research Manager, MPH

CONTACT

[email protected]

617-919-6013

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2030
Study completion
2031
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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