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Cerebellar deep brain stimulation for severe combined movement disorders and spasticity in children and young adults with cerebral palsy

Award Number: UH3NS128297
ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 04/01/2024
PERIOD OF PERFORMANCE END DATE: 03/31/2029

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Cerebellar deep brain stimulation for severe combined movement disorders and spasticity in children and young adults with cerebral palsy - Cerebral palsy (CP) encompasses a group of disorders of movement and posture, attributed to non-progressive disturbances affecting the developing brain. Movement and tone disorders in children and young adults with CP are a great source of disability. CP is the most common cause of acquired dystonia in childhood, but its management is problematic, as medications and neurotoxin denervation only provide modest benefit. Deep brain stimulation of basal ganglia or thalamic targets has a major role in the treatment of isolated dystonias, but its efficacy in dystonic CP (DCP) is much lower. Lower efficacy may be due to structural damage in basal ganglia and motor thalamus, lack of improvement of comorbid choreoathetosis and spasticity, and an increased risk of hardware complications in this population. We propose an alternative brain target for DBS in DCP, the cerebellum, leveraging recent developments in dystonia neurophysiology, brain stimulation hardware and neuroimaging. The cerebellum is an attractive target for DBS in DCP since it is frequently spared from hypoxic ischemic damage, it has a prominent role in contemporary network models of dystonia, and small studies have shown promise of cerebellar stimulation in improving spasticity and CP-related movement disorders. Ten children and young adults with CP and disabling movement disorders and spasticity will undergo bilateral DBS in dorsal (motor) dentate nucleus, with the most distal contact in superior cerebellar peduncle. We will implant Medtronic PerceptTM, an FDA-approved “bidirectional” neurostimulator that can sense and store brain activity as well as simultaneously deliver DBS therapy. Recent improvements in hardware size and brain lead fixation address the prior high complication rate reported for pediatric DBS, and provide “directional” leads for more targeted stimulation. We will characterize abnormal patterns of cerebellar oscillatory activity as measured by local field potentials (LFP) related to clinical assessments and wearable monitors, and their relation to stimulation (Aim 1). 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 (Aim 2). In Aim 3, we will test the efficacy of cerebellar stimulation for improving quality of life as well as motor outcomes as assessed by clinical assessments and objective kinematic metrics. We will use a N-of-1 clinical trial design to mitigate the variability in clinical features in this population. Our goal is to develop a neuromodulation therapy that produces meaningful changes in function and well-being of people with CP, obtain a mechanistic understanding of the underlying brain network disorder, and identify physiological and imaging-based predictors of outcome useful in planning further studies.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $959,582 )
2026	2026	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	3	4/17/2026	NON-COMPETING CONTINUATION	$959,582
														Subtotal = $959,582

Issue Date FY: 2025 ( Subtotal = $946,835 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	2	4/17/2025	NON-COMPETING CONTINUATION	$946,835
														Subtotal = $946,835

Issue Date FY: 2024 ( Subtotal = $1,148,442 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	001	1	6/3/2024	NEW	$17,399
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Extramural Research Programs in the Neurosciences and Neurological Disorders	000	1	3/13/2024	NEW	$1,131,043
														Subtotal = $1,148,442

Grand Total All Awards = $3,054,859

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Cerebellar deep brain stimulation for severe combined movement disorders and spasticity in children and young adults with cerebral palsy

Award Number: UH3NS128297

ORGANIZATION: NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 04/01/2024

PERIOD OF PERFORMANCE END DATE: 03/31/2029

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