Effectiveness of Spinal Cord Stimulation (SCS) for the Management of Freezing of Gait (FOG) and Locomotion in Parkinson's Disease

Spinal Cord Stimulation (SCS) for Freezing of Gait (FOG) in Parkinson's Disease



Sponsors

Lead Sponsor



Source

Columbia University

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

Yes

Is Unapproved Device

No

Is Ppsd

No


Brief Summary

Parkinson Disease (PD) patients experience a variety of motor issues such as walking
difficulties, loss of balance, and freezing while walking, which impacts their quality of
life. Some symptoms, like freezing of gait (FOG), do not respond to medications typically
used to treat PD. Current surgical procedures used to alleviate PD symptoms also do not
always improve FOG. Since many traditional therapies have failed for the treatment of FOG,
researchers have proposed the use of newer treatments. Recent research in animal models and
clinical human data using SCS has produced promising results, specifically showing
improvement in FOG with the use of SCS in patients with PD.

The purpose of this study is to evaluate the effectiveness of spinal cord stimulation (SCS)
for the management of freezing of gait (FOG) that does not respond to conventional treatments
in subjects with Parkinson's disease (PD). The investigators hypothesize that SCS
significantly decreases FOG episodes in patients with PD.

Aim 1: To assess the effectiveness of thoracic SCS for FOG in PD patients.

Aim 2: To evaluate the effects of SCS in locomotion, appendicular motor manifestations, and
frequency of adverse events in PD patients.

Detailed Description

Freezing of gait (FOG) is a devastating motor phenomenon which may occur in patients with
Parkinson's Disease (PD) and other neurodegenerative disorders. It is characterized by
episodes during which patients cannot generate effective forward stepping movements in the
absence of motor deficits.

FOG leads to reduced mobility, loss of independence, social embarrassment, and caregiver
stress. While most motor features of PD respond robustly to dopaminergic agents and deep
brain stimulation (DBS), there are currently no effective treatments for FOG.

Indirect evidence from case reports of PD patients undergoing spinal cord stimulation (SCS)
for neuropathic pain, has consistently described a positive effect of SCS on FOG. In
addition, two recent reports demonstrated that thoracic SCS improved locomotion and FOG in
patients with advanced PD. The promising role of SCS for the treatment of FOG in PD has
encouraged us to assemble a multi-disciplinary team for the systematic investigation of the
motor effects of SCS on FOG, locomotion and other parkinsonian features.

The current study integrates minimally invasive SCS and the use of robotic technology to
determine objective gait parameters. The investigators propose a pilot study for the
implantation of SCS to the spinal cord on PD patients with treatment-refractory FOG,
including a longitudinal assessment of motor outcomes.

Overall Status

Not yet recruiting

Start Date

2018-08-01

Completion Date

2020-10-01

Primary Completion Date

2020-08-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Change in New Freezing of Gait Questionnaire (NFOG-Q) score
Baseline (pre-surgery), 3-month post-surgery, 6-month post-surgery, 12-month post-surgery

Secondary Outcome

Measure

Time Frame

Change in Timed Up and Go (TUG) score
Baseline (pre-surgery), 3-month post-surgery, 6-month post-surgery, 12-month post-surgery
Change in 20-meter walk time (in seconds)
Baseline (pre-surgery), 3-month post-surgery, 6-month post-surgery, 12-month post-surgery
Change in SoleSound System gait measures score
Baseline (pre-surgery), 3-month post-surgery, 6-month post-surgery, 12-month post-surgery
Change in MDS-UPDRS score
Baseline (pre-surgery), 3-month post-surgery, 6-month post-surgery, 12-month post-surgery

Enrollment

10

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (4-16). Electrodes will be implanted percutaneously into the epidural space.
The implantable pulse generator (IPG) is a neurostimulation system designed to deliver low-intensity electrical impulses. The system is intended to be used with leads and extensions that are compatible with the system. This neurostimulation system is indicated (FDA approved) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The intended use in this study is considered experimental.

Arm Group Label

Spinal Cord Stimulation (SCS)

Other Name

Proclaim™ Implantable Pulse Generator with leads


Eligibility

Criteria

Inclusion Criteria:

- Males and females between older than 18 years of age.

- Able to provide informed consent

- Diagnosed with idiopathic PD (meeting at least two of the three United Kingdom (UK)
Brain Bank criteria for PD, specifically bradykinesia plus resting tremor or rigidity)
whose major complaints is levodopa refractory FOG. Levodopa refractoriness will be
defined as lack of subjective improvement on FOG episodes as reported by the patient.

- Documented dopaminergic response

- Optimized PD treatment including dopaminergic medications, and/or deep brain
stimulation (DBS) therapy

- Presence of at least two self-reported levodopa refractory episodes of FOG per day,
not limited to start hesitation

- At least one witnessed freezing event during the screening visit in the 'on'
medication state (defined as 45 minutes after a regular dose of Levodopa for the
subject being studied)

Exclusion Criteria:

- Presence of any signs or symptoms suggestive of atypical or secondary parkinsonian
syndromes, such as multiple systems atrophy (MSA), progressive supranuclear palsy
(PSP), corticobasal ganglionic degeneration, vascular or postencephalitic
parkinsonism:

- Early severe autonomic (within the first two years of symptom onset)

- Downward vertical supranuclear gaze palsy

- Early bulbar dysfunction (within the first two years of symptom onset)

- Unequivocal cerebellar abnormalities and/or cortical sensory loss

- Evidence of an alternative condition known to produce parkinsonism and plausibly
connected to patient's symptoms

- Presence of any co-morbid psychiatric illness(es) that would interfere with the
completion of the study or pose risk to the patient.

- Presence of an active infection, uncontrolled diabetes mellitus, immunosuppression or
other medical contraindications to undergoing SCS implantation

- Patients who are currently taking anticoagulants which would preclude the safe
implantation of the device.

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Nora Vanegas-Arroyave, MD
Principal Investigator
Columbia University

Overall Contact

Last Name

Darya Tomishon

Phone

212-305-5779

Email



Location

Facility

Status

Contact

Investigator

Columbia University Medical Center
New York New York 10032 United States
Not yet recruiting
Last Name: Darya Tomishon
Email: [email protected]
Last Name: Nora Vanegas-Arroyave, MD
Role: Principal Investigator

Location Countries

Country

United States


Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor-Investigator

Investigator Affiliation

Columbia University

Investigator Full Name

Nora Vanegas-Arroyave

Investigator Title

Assistant Professor of Neurology


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Spinal Cord Stimulation (SCS)

Arm Group Type

Experimental

Description

The subjects will complete pre-operative visits, spinal cord stimulator placement (device implantation - SCS) and postoperative follow-up visits on an outpatient basis.


Firstreceived Results Date

N/A

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Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Intervention Model Description

A total of 10 patients with a diagnosis of Parkinson's disease and treatment refractory freezing of gait will be recruited in this study.

Primary Purpose

Device Feasibility

Masking

None (Open Label)


Study First Submitted

May 4, 2018

Study First Submitted Qc

May 4, 2018

Study First Posted

May 16, 2018

Last Update Submitted

May 4, 2018

Last Update Submitted Qc

May 4, 2018

Last Update Posted

May 16, 2018


ClinicalTrials.gov processed this data on May 16, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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