Parkinson DiseaseDBS + FOGNCT04218526
Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease
A study testing Vercise DBS System in people with Parkinson Disease, run by Jonathan Jagid at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Vercise DBS System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2020to 12 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- 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
- 6. 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.
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Vercise DBS System
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vercise DBS SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vercise DBS Group | Experimental | All participants will have the Vercise DBS system implanted. Receives: Device: Vercise DBS System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Secondary outcomes (5)
Percent Change in FOG Questionnaire
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 .
Measured: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent Change in PDQ 39
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.
Measured: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent Change in PDQ-L
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.
Measured: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op
Percent Change in Muscle Amplitude
Percent change in muscle amplitude during gait testing using electromyography (EMG)
Measured: Baseline, 24 weeks
Percent Change in number of Falls
Percent change in number of falls during gait testing sessions and on item 13 of UPDRS III (falls unrelated to freezing)
Measured: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start27 Apr 2020
- Primary completion12 Sep 2024
- Study completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonathan Jagid
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor-investigator, Jonathan Jagid, University of Miami
- Investigators
- Jonathan R Jagid, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04218526
- Sponsor's protocol ID
- 20190702
- Acronym
- DBS + FOG
- Status last verified
- Sep 2024
- First submitted
- 2 Dec 2019
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34168545Chang 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.
PubMed 34078477
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Cuneiform Nucleus for Levodopa-resistant Freezing of Gait in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04218526
- Acronym / sponsor ID
- DBS + FOG / 20190702
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Jonathan JagidUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- Study completion
- 12 Sep 2024 (actual)
- First posted
- 6 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vercise DBS Group | Experimental | Device: Vercise DBS SystemAll participants will have the Vercise DBS system implanted. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
- 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
- 6. Minimal tremor, bradykinesia, and rigidity symptoms, or well controlled with Levodopa and/or with already implanted STN/GPi DBS.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vercise DBS SystemVercise 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. | Device | Vercise DBS Group |
Primary outcome
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.
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
5 secondary outcomes
Percent Change in FOG Questionnaire
Time frame: 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
Percent Change in PDQ-L
Time frame: 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 number of Falls
Time frame: Baseline, 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 34168545Chang 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.
- Derived from this study: PubMed 34078477Chang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan R Jagid, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vercise DBS System in people with Parkinson Disease, run by Jonathan Jagid at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Gait Velocity (time frame: Baseline, 2 week, 6 weeks, 12 weeks, 24 weeks and 25-28 week post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04218526, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.