Cerebellar Deep Brain Stimulation for Movement Disorders in Cerebral Palsy in Children and Young Adults

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT06122675
Status
Recruiting
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Conditions

  • Dyskinetic Cerebral Palsy
  • Dystonic Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
7 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • DBS — DEVICE
    Implanted in the cerebellum.

Study Details

The purpose of this study is to test the safety of placing Deep Brain Stimulators (DBS) in a part of the brain called the cerebellum and using electrical stimulation of that part of the brain to treat movement symptoms related to cerebral palsy. Ten children and young adults with dyskinetic cerebral palsy will be implanted with a Medtronic Percept Primary Cell Neurostimulator. We will pilot videotaped automated movement recognition techniques and formal gait analysis, as well as collect and characterize each subject's physiological and neuroimaging markers that may predict hyperkinetic pathological states and their response to therapeutic DBS.

Key Dates

Start date
Mar 26, 2024
Status verified
Jun 2026
Primary completion
Jan 1, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Effective stimulation
    All participants will receive deep brain stimulation (DBS) in the cerebellum. For the first 20 weeks, every participant undergoes an open label phase to titrate stimulation and determine optimal stimulation settings. Following that phase, each participant starts three cycles of randomized, paired 8-week exposure periods, each pair including effective stimulation followed by sham stimulation, or vice versa. Effective stimulation will be the optimal stimulation settings determined during the open label phase.
  • Sham Comparator: Sham stimulation
    Sham stimulation will be settings at low amplitude (0.1mA) known to be ineffective.

Primary Outcome Measure

Average total (global index) Movement Disorder-Childhood Rating Scale 4-18 Revised (MD-CRS 4-18-R) scores [ Time Frame: Evaluated weekly during randomized blinded phase (total of 3 months in each condition, sham stimulation and effective stimulation). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Marta San Luciano Palenzuela, MD
[email protected]

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By research site
University of California, San Francisco· San Francisco, CA

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