Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease (DBS + FOG)

September 12, 2024 updated by: Jonathan Jagid
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vercise DBS Group
All participants will have the Vercise DBS system implanted.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Gait Velocity
Time Frame: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
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
Time Frame: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in FOG Questionnaire
Time Frame: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Freezing of Gait (FOG) Questionnaire is a 6-item questionnaire with each item scored from 0-4. The total score ranges from 0-24 with the higher score indicating more severe freezing of gait .
Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent Change in PDQ 39
Time Frame: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Parkinson's Disease Questionnaire (PDQ-39) is 39-item questionnaire with a total score ranging from 0-156 with the higher score indicating poorer quality of life.
Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent Change in PDQ-L
Time Frame: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Parkinson's Disease Quality of Life Questionnaire is a 37-item questionnaire with a total score ranging from 0-185 with the higher score indicating poorer quality of life.
Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent Change in Muscle Amplitude
Time Frame: Baseline, 24 weeks
Percent change in muscle amplitude during gait testing using electromyography (EMG)
Baseline, 24 weeks
Percent Change in number of Falls
Time Frame: Baseline, 24 weeks
Percent change in number of falls during gait testing sessions and on item 13 of UPDRS III (falls unrelated to freezing)
Baseline, 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jonathan Jagid

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Jonathan R Jagid, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

September 12, 2024

Study Completion (Actual)

September 12, 2024

Study Registration Dates

First Submitted

December 2, 2019

First Submitted That Met QC Criteria

January 3, 2020

First Posted (Actual)

January 6, 2020

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 12, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190702

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson Disease

Clinical Trials on Vercise DBS System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe