{
  "abstract": "Introduction: Dystonia, a form of elevated muscle tone in CP, significantly impairs function and quality of life. Multiple neurosurgical interventions are used to reduce dystonia, including intrathecal baclofen (ITB) and ventral dorsal rhizotomy (VDR). ITB is used most often for moderate to severe generalised dystonia in CP; however, the evidence supporting its effectiveness is weak due to patient variability and study limitations. Further, VDR is becoming more prevalent but there is minimal data available on its outcomes. This proposal aims to evaluate ITB and VDR’s ability to reduce quantitative and functionally impactful dystonia as well as reduce spasticity, improve motor function, improve mood and improve quality of life. Secondary analysis will focus on identifying child characteristics of a positive response to ITB and VDR to allow for better patient selection.\n\nMethods and analysis: We will conduct a prospective observational study of 52 children with CP and moderate-severe dystonia (Barry Albright Dystonia Scale (BADS) greater than 14) who receive ITB (n=35) and VDR (n=17). Children will be enrolled at three sites in the USA: Texas Children’s Hospital (Houston), Lurie Children’s Hospital (Chicago) and C.S. Mott Children’s Hospital (Ann Arbor). Changes will be measured in dystonia, spasticity, gross and fine motor function and multiple patient-reported outcomes related to quality of life, participation, depression, anxiety and pain. Children enrolled in the study will undergo detailed characterisation of brain malformation and injury patterns. The primary analysis will use repeated measures models to estimate changes from baseline in BADS scores at 3, 6 and 12 months. Secondary analyses will apply the same strategies to the other outcome measures. Subgroup analyses will investigate unique characteristics of children with a positive response to either intervention. A multidimensional or composite measure will also be created.\n\nEthics and dissemination: Primary ethics approval was provided by the Baylor College of Medicine Institutional Review Board (H-54449). Primary caregivers of all participants were consented for the study. Participants with capacity were asked to assent. Results of the study will be disseminated via peer-reviewed presentations at scientific conferences and open access publication.\n\nTrial registration number: NCT06606574 .",
  "abstract_shown": true,
  "affiliations": [
    "H.Ben Taub Department of Physical Medicine and Rehabilitation, Baylor College of Medicine, Houston, Texas, USA",
    "Department of Psychiatry and Behavioral Health, Virginia Tech Carilion School of Medicine, Roanoke, Virginia, USA",
    "Division of Translational Research and Applied Statistics, Department of Public Health Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA",
    "Department of Radiology, Texas Children’s Hospital, Houston, Texas, USA",
    "Department of Surgery, Texas Children’s Hospital, Houston, Texas, USA",
    "Department of Neurological Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA",
    "Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA",
    "Department of Neurosurgery, University of Michigan Michigan Medicine, Ann Arbor, Michigan, USA",
    "Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, Toronto, Ontario, Canada",
    "Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 9,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Sruthi Pandipati Thomas",
      "orcid": "0000-0001-5259-4136"
    },
    {
      "affs": [
        1
      ],
      "name": "Sharon Ramey"
    },
    {
      "affs": [
        2
      ],
      "name": "Mark Conaway"
    },
    {
      "affs": [
        3
      ],
      "name": "Stephen Kralik"
    },
    {
      "affs": [
        4
      ],
      "name": "Rachel Arp"
    },
    {
      "affs": [
        5
      ],
      "name": "Jeffrey S. Raskin"
    },
    {
      "affs": [
        6
      ],
      "name": "Nisha Gadgil"
    },
    {
      "affs": [
        7
      ],
      "name": "Neena Marupudi"
    },
    {
      "affs": [
        8,
        9
      ],
      "name": "Darcy Fehlings"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9evtj8jaxcg2q.bib",
  "cited_by": 0,
  "doi": "10.1136/bmjopen-2026-123926",
  "fulltext_url": null,
  "id": "9evtj8jaxcg2q",
  "issns": [
    "2044-6055",
    "2044-6055"
  ],
  "landing_url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123926",
  "language": null,
  "licence": "CC-BY-NC-4.0",
  "licence_label": "CC BY-NC 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by-nc/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "2738|Cerebral Palsy and Movement Disorders"
    ]
  ],
  "openalex": "W7220703302",
  "pdf_url": "https://bmjopen.bmj.com/content/bmjopen/16/10/e123926.full.pdf",
  "pmcid": null,
  "pmid": null,
  "published": "2026-10-06",
  "publisher": "BMJ",
  "ris": "https://research.draconitic.com/paper/9evtj8jaxcg2q.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:19:44Z",
      "native_id": "10.1136/bmjopen-2026-123926",
      "source": "crossref",
      "url": "https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-123926"
    }
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  "subjects": [
    {
      "field": "medicine",
      "origin": "openalex:2738|Cerebral Palsy and Movement Disorders",
      "subfield": "psychiatry"
    }
  ],
  "title": "Investigating the effects of intrathecal baclofen and ventral-dorsal rhizotomy on dystonia in children with cerebral palsy (PREDICT-Dystonia): protocol for a prospective observational clinical trial",
  "title_text": "Investigating the effects of intrathecal baclofen and ventral-dorsal rhizotomy on dystonia in children with cerebral palsy (PREDICT-Dystonia): protocol for a prospective observational clinical trial",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:19:44Z",
  "url": "https://research.draconitic.com/paper/9evtj8jaxcg2q",
  "venue": "BMJ Open",
  "versions": []
}