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

Last updated: June 2, 2020
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04223427
2018/0427/HP
  • Ages 18-70
  • All Genders

Study 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

Inclusion Criteria:

  1. Age between 18 and 70 years

  2. Diagnosis of Parkinson's Disease; as defined by the United Kingdom Parkinson's DiseaseSociety Brain Bank (UKPDSBB) criteria

  3. Patients eligible for subthalamic bilateral deep brain stimulation (STN-DBS) accordingto local inclusion criteria;

  4. Freezing of gait in the OFF-dopa condition with item 2.13 of the MDS-UPDRS > 0 inusual life;

  5. Patient having read and understood the information letter and signed the InformedConsent 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 researchprotocol.

  8. Woman of childbearing potential with effective contraception according to WHOdefinition (estrogen-progestin or intra-uterine device or tubal ligation) since atleast 3 months (negative urinary pregnancy test at inclusion)

Exclusion

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 nervestructures, cardiac, ORL and neurological devices not MRI compatible, wearing ofosteosynthseis equipment prior to 1980, metal prostheses, bypass valvesventriculoperitoneal neurosurgery, tattoos containing iron particles…

  4. Contraindication to surgery: hemostasis trouble, anticoagulants or antiagregantstreatment, ongoing infection

  5. Hypersensitivity to contrasts agents

  6. Persons under guardianship, tutorship or any other administrative or judicial measureof deprivation of rights and liberty

  7. Subject at the time of exclusion from other biomedical research or participating inany other biomedical research or therapeutic trial

  8. Pregnant or parturient or lactating woman or lack of proven and effectivecontraception according to WHO definition (estrogen-progestin or intra-uterine deviceor tubal ligation) (for women of childbearing age)

Study Design

Total Participants: 10
Study Start date:
January 14, 2020
Estimated Completion Date:
February 28, 2022

Connect with a study center

  • CHU de ROUEN

    Rouen, 76000
    France

    Active - Recruiting

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