Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients

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Recruiting
participants needed

10
sponsor

University Hospital, Rouen

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Updated on 19 February 2024

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estrogen

brain stimulation

tubal ligation

parkinson's disease

dopa

Summary

Deep brain stimulation of the NST is effective for cardinal motor signs in patients with idiopathic Parkinson's disease (IPD), its effects on gait disturbances, especially freezing of gait-FOG, and falls are variable from one patient to another, in part depending on the location of the NST-stimulating contact. The ability to change the shape of the current field, and thus the volume of activated tissue, with a directional stimulation electrode is a new treatment option for NSC SCP patients with Parkinson's disease. In this pilot research program, the main objective is to determine the impact of directional DBS on gait and balance issues for PD patients implanted in the STN, using previously described anatomical and functional data for gait disturbances to guide directional programming. Ten patients with Patients with severe form of Parkinson's disease eligible to deep brain stimulation of the subthalamic nucleus, will be included in two French sites.

Details

Condition	Parkinson's Disease, Parkinson's Disease
Age	18years - 70years
Treatment	Directional and single ring STN-DBS on gait
Clinical Study Identifier	NCT04223427
Sponsor	University Hospital, Rouen
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age between 18 and 70 years
	Diagnosis of Parkinson's Disease; as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
	Patients eligible for subthalamic bilateral deep brain stimulation (STN-DBS) according to local inclusion criteria
	Freezing of gait in the OFF-dopa condition with item 2.13 of the MDS-UPDRS > 0 in usual life
	Patient having read and understood the information letter and signed the Informed Consent Form
	Patient affiliated with, or beneficiary of a social security category
	Stability of others medical disorders or that do not interfere with the research protocol
	Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestin or intra-uterine device or tubal ligation) since at least 3 months (negative urinary pregnancy test at inclusion)
Exclusion Criteria
	Actual and severe psychiatric pathology or other neurological disorder
	Dementia (MMS <24/30)
	Contraindication to research MRI (without contrast product) such as claustrophobia, metallic splinters in the eyes, ferromagnetic foreign bodies close to nerve structures, cardiac, ORL and neurological devices not MRI compatible, wearing of osteosynthseis equipment prior to 1980, metal prostheses, bypass valves ventriculoperitoneal neurosurgery, tattoos containing iron particles
	Contraindication to surgery: hemostasis trouble, anticoagulants or antiagregants treatment, ongoing infection
	Hypersensitivity to contrasts agents
	Persons under guardianship, tutorship or any other administrative or judicial measure of deprivation of rights and liberty
	Subject at the time of exclusion from other biomedical research or participating in any other biomedical research or therapeutic trial
	Pregnant or parturient or lactating woman or lack of proven and effective contraception according to WHO definition (estrogen-progestin or intra-uterine device or tubal ligation) (for women of childbearing age)

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Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients