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

Primary Purpose

Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Directional and single ring STN-DBS on gait
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU de ROUENRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single ring STN-DBS

Directional STN-DBS

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 10, 2019
Last Updated
June 2, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04223427
Brief Title
Effects of Directional Subthalamic Deep Brain Stimulation on Gait and Balance in Parkinson's Disease Patients
Acronym
MAGIC
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

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 14, 2020 (Actual)
Primary Completion Date
January 14, 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single ring STN-DBS
Arm Type
Active Comparator
Arm 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.
Arm Title
Directional STN-DBS
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Directional and single ring STN-DBS on gait
Intervention Description
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 Measure Information:
Title
Changes in the principal components analysis (PCA) of the gait initiation kinetics during gait initiation with cognitive interference
Description
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).
Time Frame
7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
CHU de ROUEN
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure Welter
Phone
02 32 88 86 98
Email
Marie-Laure.Welter@chu-rouen.fr

12. IPD Sharing Statement

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

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