دورية أكاديمية
أعرض في EDS

Protocol for combined N-of-1 trials to assess cerebellar neurostimulation for movement disorders in children and young adults with dyskinetic cerebral palsy.

التفاصيل البيبلوغرافية
العنوان: Protocol for combined N-of-1 trials to assess cerebellar neurostimulation for movement disorders in children and young adults with dyskinetic cerebral palsy.
المؤلفون: San Luciano M; Movement Disorders and Neuromodulation Center, Department of Neurology, University of California San Francisco, Weill Institute for Neurosciences, 1651 4th Street Level 3 SW Academic Offices, Box #1838, 94158, San Francisco, CA, USA. marta.sanlucianopalenzuela@ucsf.edu., Oehrn CR; Department of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA., Wang SS; Movement Disorders and Neuromodulation Center, Department of Neurology, University of California San Francisco, Weill Institute for Neurosciences, 1651 4th Street Level 3 SW Academic Offices, Box #1838, 94158, San Francisco, CA, USA., Tolmie JS; Movement Disorders and Neuromodulation Center, Department of Neurology, University of California San Francisco, Weill Institute for Neurosciences, 1651 4th Street Level 3 SW Academic Offices, Box #1838, 94158, San Francisco, CA, USA., Wiltshire A; Movement Disorders and Neuromodulation Center, Department of Neurology, University of California San Francisco, Weill Institute for Neurosciences, 1651 4th Street Level 3 SW Academic Offices, Box #1838, 94158, San Francisco, CA, USA., Graff RE; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA., Zhu J; Movement Disorders and Neuromodulation Center, Department of Neurology, University of California San Francisco, Weill Institute for Neurosciences, 1651 4th Street Level 3 SW Academic Offices, Box #1838, 94158, San Francisco, CA, USA., Starr PA; Department of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
المصدر: BMC neurology [BMC Neurol] 2024 Apr 29; Vol. 24 (1), pp. 145. Date of Electronic Publication: 2024 Apr 29.
نوع المنشور: Journal Article; Clinical Trial Protocol; Research Support, Non-U.S. Gov't; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 100968555 Publication Model: Electronic Cited Medium: Internet ISSN: 1471-2377 (Electronic) Linking ISSN: 14712377 NLM ISO Abbreviation: BMC Neurol Subsets: MEDLINE
أسماء مطبوعة: Original Publication: London : BioMed Central, [2001-
مواضيع طبية MeSH: Cerebral Palsy*/therapy , Cerebral Palsy*/physiopathology , Deep Brain Stimulation*/methods , Movement Disorders*/therapy , Cerebellum*/diagnostic imaging, Humans ; Child ; Adolescent ; Young Adult ; Male ; Female ; Adult
مستخلص: Background: Movement and tone disorders in children and young adults with cerebral palsy are a great source of disability. Deep brain stimulation (DBS) of basal ganglia targets has a major role in the treatment of isolated dystonias, but its efficacy in dyskinetic cerebral palsy (DCP) is lower, due to structural basal ganglia and thalamic damage and lack of improvement of comorbid choreoathetosis and spasticity. The cerebellum is an attractive target for DBS in DCP since it is frequently spared from hypoxic ischemic damage, it has a significant role in dystonia network models, and small studies have shown promise of dentate stimulation in improving CP-related movement and tone disorders.
Methods: Ten children and young adults with DCP and disabling movement disorders with or without spasticity will undergo bilateral DBS in the dorsal dentate nucleus, with the most distal contact ending in the superior cerebellar peduncle. We will implant Medtronic Percept, a bidirectional neurostimulator that can sense and store brain activity and deliver DBS therapy. The efficacy of cerebellar DBS in improving quality of life and motor outcomes will be tested by a series of N-of-1 clinical trials. Each N-of-1 trial will consist of three blocks, each consisting of one month of effective stimulation and one month of sham stimulation in a random order with weekly motor and quality of life scales as primary and secondary outcomes. In addition, we will characterize abnormal patterns of cerebellar oscillatory activity measured by local field potentials from the intracranial electrodes related to clinical assessments and wearable monitors. Pre- and 12-month postoperative volumetric structural and functional MRI and diffusion tensor imaging will be used to identify candidate imaging markers of baseline disease severity and response to DBS.
Discussion: Our goal is to test a cerebellar neuromodulation therapy that produces meaningful changes in function and well-being for people with CP, obtain a mechanistic understanding of the underlying brain network disorder, and identify physiological and imaging-based predictors of outcomes useful in planning further studies.
Trial Registration: ClinicalTrials.gov NCT06122675, first registered November 7, 2023.
(© 2024. The Author(s).)
التعليقات: Update of: Res Sq. 2024 Apr 01;:. (PMID: 38645256)
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معلومات مُعتمدة: UH3 NS128297 United States NS NINDS NIH HHS
فهرسة مساهمة: Keywords: Cerebellum; Children; Deep brain stimulation; Dentate nucleus; Dyskinetic cerebral palsy; Electrophysiology; Young adults
سلسلة جزيئية: ClinicalTrials.gov NCT06122675
تواريخ الأحداث: Date Created: 20240429 Date Completed: 20240430 Latest Revision: 20240522
رمز التحديث: 20240523
مُعرف محوري في PubMed: PMC11057158
DOI: 10.1186/s12883-024-03633-z
PMID: 38684956
قاعدة البيانات: MEDLINE
الوصف
تدمد:1471-2377
DOI:10.1186/s12883-024-03633-z