Clinical trial NCT04223427: Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients
Official title: Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients - MApping Gait and Balance Issues With Current Shaping
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-01-10
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The order of the five STN-DBS stimulation conditions will be randomized and assessments will be performed blinded from the stimulation condition. The effects of STN DBS on gait recordings will be assessed in 5 different conditions: with single ring DBS (1), and with current shaping for DBS of the gait 'hot spot' (2), of the dorsal STN (3) of the ventral STN (4) and of the DBS of narrow fiber tracts (5). The first condition will always be the single ring DBS.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 70 years
2. Diagnosis of Parkinson's Disease; as defined by the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria
3. Patients eligible for subthalamic bilateral deep brain stimulation (STN-DBS) according to local inclusion criteria;
4. Freezing of gait in the OFF-dopa condition with item 2.13 of the MDS-UPDRS \> 0 in usual life;
5. Patient having read and understood the information letter and signed the Informed Consent Form
6. Patient affiliated with, or beneficiary of a social security category
7. Stability of others medical disorders or that do not interfere with the research protocol.
8. 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:

1. Actual and severe psychiatric pathology or other neurological disorder
2. Dementia (MMS \<24/30)
3. 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...
4. Contraindication to surgery: hemostasis trouble, anticoagulants or antiagregants treatment, ongoing infection
5. Hypersensitivity to contrasts agents
6. Persons under guardianship, tutorship or any other administrative or judicial measure of deprivation of rights and liberty
7. Subject at the time of exclusion from other biomedical research or participating in any other biomedical research or therapeutic trial
8. 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)

Primary outcomes:
measure: Changes in the principal components analysis (PCA) of the gait initiation kinetics during gait initiation with cognitive interference
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de ROUEN
Study officials:
References: