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

NCT04218526 | Completed DMC FDA Device

• 1 other identifier: 20190702
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (2)

• Percent Change in Gait Velocity

  Percent change in gait velocity with and without bilateral cuneiform nucleus deep brain stimulation. Over a distance of 3 meters, gait velocity will be measured using the timed Up and Go test instrumented with Mobility Lab accelerometers.

  Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op

• Percent change in UPDRS Part III on/off stimulation

  Percent change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III on/off stimulation across study visits relative to pre-operative assessment

  Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op

Secondary Outcomes (5)

• Percent Change in FOG Questionnaire

  Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op

• Percent Change in PDQ 39

  Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op

• Percent Change in PDQ-L

  Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op

• Percent Change in Muscle Amplitude

  Baseline, 24 weeks

• Percent Change in number of Falls

  Baseline, 24 weeks

Study Arms (1)

Vercise DBS Group

EXPERIMENTAL

All participants will have the Vercise DBS system implanted.

Device: Vercise DBS System

Interventions

Vercise DBS System 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.

Vercise DBS Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Age 40-75 with good response to Levodopa (defined as greater than 20% improvement in UPDRS score)
• FOG refractory to LEVODOPA\>600 mg
• \. Minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with Levodopa and/or with already implanted STN/GPi DBS.
• 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
• Must agree to full 6-month participation in study.

You may not qualify if:

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

Sponsors & Collaborators

• Jonathan Jagid: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (2)

• Chang SJ, Cajigas I, Guest JD, Noga BR, Widerstrom-Noga E, Haq I, Fisher L, Luca CC, Jagid JR. MR Tractography-Based Targeting and Physiological Identification of the Cuneiform Nucleus for Directional DBS in a Parkinson's Disease Patient With Levodopa-Resistant Freezing of Gait. Front Hum Neurosci. 2021 Jun 8;15:676755. doi: 10.3389/fnhum.2021.676755. eCollection 2021.

  PMID: 34168545 DERIVED

• Chang SJ, Cajigas I, Guest JD, Noga BR, Widerstrom-Noga E, Haq I, Fisher L, Luca CC, Jagid JR. Deep brain stimulation of the Cuneiform nucleus for levodopa-resistant freezing of gait in Parkinson's disease: study protocol for a prospective, pilot trial. Pilot Feasibility Stud. 2021 Jun 2;7(1):117. doi: 10.1186/s40814-021-00855-7.

  PMID: 34078477 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan R Jagid, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurological Surgery, Neurology, Orthopedics, and Rehabilitation

Study Record Dates

• First Submitted: December 2, 2019
• First Posted: January 6, 2020
• Study Start: April 27, 2020
• Primary Completion: September 12, 2024
• Study Completion: September 12, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)