Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04223427
Recruitment Status : Not yet recruiting
First Posted : January 10, 2020
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Procedure: Directional and single ring STN-DBS on gait Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Single ring STN-DBS
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.
Procedure: Directional and single ring STN-DBS on gait

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)


Experimental: Directional STN-DBS
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.
Procedure: Directional and single ring STN-DBS on gait

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 Outcome Measures :
  1. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Layout table for additonal information
Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT04223427    
Other Study ID Numbers: 2018/0427/HP
First Posted: January 10, 2020    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases