Evidence map›Paper›PMID 38684956›Full record

ArticleBMC neurology2024

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

M San Luciano, C R Oehrn, S S Wang, J S Tolmie, A Wiltshire, R E Graff, J Zhu, P A Starr

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC neurology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06122675 (Cerebellar Deep Brain Stimulation for Severe Combined Movement Disorders and Spasticity in Children and Young Adults With Cerebral Palsy), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06122675 narecruitingnot on this map

Cerebellar Deep Brain Stimulation for Severe Combined Movement Disorders and Spasticity in Children and Young Adults With Cerebral Palsy

TypeinterventionalSponsorUniversity of California, San FranciscoRan2024 to 2029Enrolled10ConditionsDyskinetic Cerebral Palsy, Dystonic Cerebral PalsyArmsDBS
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Review
  5. Article
  6. Article
  7. Beyond Pallidal or Subthalamic Deep Brain Stimulation to Treat Dystonia.Tremor and other hyperkinetic movements (New York, N.Y.) · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 1 institution in 1 country.

M San LucianoMovement 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.
C R OehrnDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
S S WangMovement 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.
J S TolmieMovement 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.
A WiltshireMovement 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.
R E GraffDepartment of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA, USA.
J ZhuMovement 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.
P A StarrDepartment of Neurological Surgery, University of California San Francisco, San Francisco, CA, USA.
University of California, San Francisco · US

Funding

Cerebellar deep brain stimulation for severe combined movement disorders and spasticity in children and young adults with cerebral palsyUH3NS128297 · NINDS · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI Marta San Luciano · 2024 to 2026
$3.1M
NINDS NIH HHS UH3 NS128297
6 · The paper itself

Abstract

backgroundMovement 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.

methodsTen 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 registrationClinicalTrials.gov NCT06122675, first registered November 7, 2023.

Indexed as

CerebellumCerebral PalsyDeep Brain StimulationMovement DisordersAdolescentAdultChildFemaleHumansMaleYoung AdultCerebellumChildrenDeep brain stimulationDentate nucleusDyskinetic cerebral palsyElectrophysiologyYoung adults

Identifiers

PMID38684956
PMCPMC11057158
OpenAlexW4396228029

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.