Spastic/Dystonic QuadriplegiaNCT07817745
Outcomes of Neurosurgical Tone Management
An observational study of Spastic/Dystonic Quadriplegia and Cerebral Palsy (CP), run by Boston Children's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 25 years
- Conditions the study is for
- Spastic/Dystonic Quadriplegia, Cerebral Palsy (CP)
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2024to 1 Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients will be recruited from the Cerebral Palsy and multidisciplinary tone management clinic.
Who may be able to join
- 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
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Adam Porter, MPH, 617-919-6013, adam.porter@childrens.harvard.edu
Weston Northam, MD
About this study
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.
- Conditions
- Spastic/Dystonic Quadriplegia, Cerebral Palsy (CP)
- Keywords
- CP, Cerebral Palsy, Tone Management, Dystonic, Spastic, Spasticity, Intrathecal Baclofen Pump, Combined Dorsal/Ventral Rhizotomy
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Spasticity Score
We will study changes in Spasticity using the Modified Ashworth Scale in participants over the course of this study.
Measured: From enrollment to 5 years
Improved Dystonia Score
We will use the Barry Albright Dystonia Scale to measure changes in dystonia in participants over the course of this study.
Measured: From enrollment to 5 years.
Secondary outcomes (2)
Overall Quality of Life Improvements
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.
Measured: From enrollment to 5 years
Reduced Surgical Complications
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.
Measured: From enrollment to 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start26 Jun 2024
- Primary completion1 Jul 2030 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spastic/Dystonic QuadriplegiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weston Thomas Northam, Boston Children's Hospital
- Investigators
- Weston Northam, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817745
- Sponsor's protocol ID
- IRB-P00048225
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The study is currently undecided about IPD sharing due to IRB and participant confidentiality considerations, entity-level legal requirements, and the ongoing status of the study.
Publications
Ahluwalia R, Bass P, Flynn L, Martin E, Riordan H, Lawrence A, Naftel RP. Conus-level combined dorsal and ventral lumbar rhizotomy for treatment of mixed hypertonia: technical note and complications. J Neurosurg Pediatr. 2020 Oct 9;27(1):102-107. doi: 10.3171/2020.6.PEDS20295. Print 2021 Jan 1.
PubMed 33036004Abdel Ghany WA, Nada M, Mahran MA, Aboud A, Mahran MG, Nasef MA, Gaber M, Sabry T, Ibrahim MH, Taha MH. Combined Anterior and Posterior Lumbar Rhizotomy for Treatment of Mixed Dystonia and Spasticity in Children With Cerebral Palsy. Neurosurgery. 2016 Sep;79(3):336-44. doi: 10.1227/NEU.0000000000001271.
PubMed 27244465Albright AL, Tyler-Kabara EC. Combined ventral and dorsal rhizotomies for dystonic and spastic extremities. Report of six cases. J Neurosurg. 2007 Oct;107(4 Suppl):324-7. doi: 10.3171/PED-07/10/324.
PubMed 17941499
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Neurosurgical Tone Management
- ClinicalTrials.gov ID
- NCT07817745
- Acronym / sponsor ID
- IRB-P00048225
- Conditions
- Spastic/Dystonic Quadriplegia, Cerebral Palsy (CP)
- Keywords
- CP, Cerebral Palsy, Tone Management, Dystonic, Spastic, Spasticity, Intrathecal Baclofen Pump, Combined Dorsal/Ventral Rhizotomy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 1 Jul 2030 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients will be recruited from the Cerebral Palsy and multidisciplinary tone management clinic.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
2 secondary outcomes
Overall Quality of Life Improvements
Time frame: From enrollment to 5 years
Reduced Surgical Complications
Time frame: From enrollment to 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 33036004Ahluwalia R, Bass P, Flynn L, Martin E, Riordan H, Lawrence A, Naftel RP. Conus-level combined dorsal and ventral lumbar rhizotomy for treatment of mixed hypertonia: technical note and complications. J Neurosurg Pediatr. 2020 Oct 9;27(1):102-107. doi: 10.3171/2020.6.PEDS20295. Print 2021 Jan 1.
- Background: PubMed 27244465Abdel Ghany WA, Nada M, Mahran MA, Aboud A, Mahran MG, Nasef MA, Gaber M, Sabry T, Ibrahim MH, Taha MH. Combined Anterior and Posterior Lumbar Rhizotomy for Treatment of Mixed Dystonia and Spasticity in Children With Cerebral Palsy. Neurosurgery. 2016 Sep;79(3):336-44. doi: 10.1227/NEU.0000000000001271.
- Background: PubMed 17941499Albright AL, Tyler-Kabara EC. Combined ventral and dorsal rhizotomies for dystonic and spastic extremities. Report of six cases. J Neurosurg. 2007 Oct;107(4 Suppl):324-7. doi: 10.3171/PED-07/10/324.
- Individual participant dataSharing planned: Undecided. The study is currently undecided about IPD sharing due to IRB and participant confidentiality considerations, entity-level legal requirements, and the ongoing status of the study.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weston Northam, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spastic/Dystonic Quadriplegia and Cerebral Palsy (CP), run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Porter, Research Manager, MPH (617-919-6013, adam.porter@childrens.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved Spasticity Score (time frame: From enrollment to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07817745, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.