Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2024-09-12

Brief Summary

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The purpose of this research study is to determine if DBS is a safe and effective therapy for severe freezing of gait in patients with Parkinson's Disease. Freezing of gait (FOG) is a particularly debilitating motor deficit seen in a subset of patients with Parkinson's Disease (PD).

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Detailed Description

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vercise DBS Group

All participants will have the Vercise DBS system implanted.

Group Type EXPERIMENTAL

Vercise DBS System

Intervention Type DEVICE

Vercise Deep Brain Stimulation (DBS) System that consists of two bilateral directional DBS Cartesia electrodes implanted in the cuneiform nucleus and a Gevia generator implanted in the upper chest area just below the clavicle.

Interventions

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Vercise DBS System

Vercise Deep Brain Stimulation (DBS) System that consists of two bilateral directional DBS Cartesia electrodes implanted in the cuneiform nucleus and a Gevia generator implanted in the upper chest area just below the clavicle.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Confirmed Parkinson's Disease according to movement disorder neurologist with documented exclusion of other disorders such as fronto-temporal dementia (FTD)/ frontal gait disorder/normal pressure hydrocephalus (NPH)/progressive supranuclear palsy (PSP)
2. PD stage3 ON medication, with severe gait dysfunction and predominant axial symptoms: Movement Disorder Society-Unified Parkinson's Disease Rating Scale Tremor Dominant (MDS-UPDRS TD), Postural Instability Gait Difficulty (PIGD) ratio ≤ 0.90 and Freezing Of Gait Questionnaire (FOGQ) score \> 12.
3. Age 40-75 with good response to Levodopa (defined as greater than 20% improvement in UPDRS score)
4. FOG refractory to LEVODOPA\>600 mg
5. 6\. Minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with Levodopa and/or with already implanted STN/GPi DBS.
6. a) Poor candidate for STN or GPi DBS due to good control of tremor, bradykinesia, and rigidity symptoms with Levodopa b) or Post-operative STN/GPi DBS PD patients with significant residual non-levodopa responsive postural and gait instability
7. Must agree to full 6-month participation in study.

Exclusion:

1. Individuals with major executive dysfunction
2. Individuals with dementia, as defined by the Mattis Dementia Rating Scale-2 (DRS-2) score ≤ 130
3. Individuals with other neurocognitive impairments
4. Individuals who have depression, as defined for example by the Beck Depression Inventory II (BDI-II) \> 25
5. Presence of major medical co-morbidities and other surgical contra-indications such as coagulopathy
6. Individuals who require diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
7. Individuals with a history of prior intracranial surgery
8. Individuals with a metallic implant in their head that is not MRI compatible (e.g., aneurysm clip, cochlear implant)
9. Individuals with active implantable devices anywhere in the body (e.g. cardiac pacemaker, defibrillator, spinal cord stimulator, implanted medication pump)
10. Individuals who are pregnancy or desire to become pregnant during the study
11. Individuals who are breastfeeding12.
12. Individuals who are on investigational drugs and any other intervention (not part of the guidelines for management of Parkinson's Disease) known to have a potential impact on outcome
13. Subjects utilizing recreational drugs at the time of screening will be excluded from the study with the exception of medicinal marijuana

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No