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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de ROUEN

Rouen, France, 76000

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Directional and single ring STN-DBS on gait

Procedure

Surgery for STN-DBS and STN-LFP recordings during gait initiation (M1): 15 days

Surgery for STN-DBS electrodes implantation

Placement of stimulation electrodes according to the usual procedure, including a MRI with contrast product
Intraoperative electrophysiological recordings
Intraoperative clinical evaluation
Intraoperative identification of the electrodes and final position with X-Ray
Post-operative 3D helical TDM without iode injection
STN-LFP recordings during gait initiation performed 3 to 5 days after surgery
Placement of the neurostimulator (5 days after surgery)
Acute testing of STN-DBS for first parameters setting programming

Follow-up of the patient with outpatient visits as usually performed in PD patients operated for STN-DBS with progressive adaptation of parameters settings using single-ring stimulation.

Directional and single ring STN-DBS on gait (M7)

Primary outcomes

Changes in the principal components analysis (PCA) of the gait initiation kinetics during gait initiation with cognitive interference

Time frame: 7 months

The primary endpoint will be the changes in Euclidian distance in the principal components analysis (PCA) of the gait initiation kinetics during gait initiation with cognitive interference (Go, No Go paradigm), reproducing at least partly situations where FOG occurred, between stimulation conditions (Varriale, Collomb-Clerc, et al., 2018).

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study 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

Acronym: MAGIC

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Jan 10, 2020
Registry last updated: Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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