Exploring the Effects of Spinal Cord Stimulation in Parkinson's Disease.

NCT03526991 | Completed FDA Device

• 1 other identifier: H-49023
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

1. 1.Assess the safety, tolerability and preliminary evidence of effectiveness of upper thoracic spinal cord stimulation for freezing of gait in Parkinson's (PD) patients.
2. 2.Explore the effects of two SCS programming paradigms on motor, nonmotor and quality of life measures in PD patients with freezing of gait.

Conditions

Parkinson Disease

Keywords

Freezing of Gait; Locomotion; Spinal cord stimulation

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability

  Incidence of Adverse Events as assessed by Adverse Event reporting.

  12-months

Secondary Outcomes (6)

• Change in New Freezing of Gait Questionnaire (NFOG-Q) score

  Baseline (pre-surgery), and over a 12month follow up period

• 10-meter walk

  Baseline (pre-surgery), and over a 12-month follow up period

• Montreal Cognitive Assessment (MoCA),

  Baseline (pre-surgery), and over a 12month follow up period

• Change in MDS-UPDRS score

  Baseline (pre-surgery), and over a 12month follow up period

• Non-Motor Symptoms Scale (NMSS)

  Baseline (pre-surgery), and over a 12month follow up period

Study Arms (2)

Spinal Cord Stimulation (SCS) Tonic stimulation

EXPERIMENTAL

Tonic stimulation

Device: Spinal Cord Stimulator (SCS)

Spinal Cord Stimulation (SCS) Burst stimulation

EXPERIMENTAL

Burst stimulation.

Device: Spinal Cord Stimulator (SCS)

Interventions

Spinal Cord Stimulator (SCS) DEVICE

The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (8). Two leads 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.

Also known as: Proclaim™ Implantable Pulse Generator with leads

Spinal Cord Stimulation (SCS) Burst stimulation; Spinal Cord Stimulation (SCS) Tonic stimulation

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• Presence of any co-morbid psychiatric illness(es) that would interfere with the completion of the study or pose risk to the patient, as defined below:
• Presence of psychosis
• Depression BDI \>14
• Anxiety BAI \>14
• Presence of an active infection, uncontrolled diabetes mellitus, immunosuppression or other medical contraindications to undergoing SCS implantation
• Patients who are currently on anticoagulation treatment or unable to hold off the anticoagulants (including Plavix, Aspirin, Warfarin, etc.) 7 days prior to the SCS procedure.
• Moderate Cognitive Impairment defined by a MoCA \< 23
• Diagnosis of failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) or intractable low back pain and leg pain.
• Women of childbearing potential will be excluded as from participation due to the limited safety data of thoracic SCS on the fetus.

Sponsors & Collaborators

• Nora Vanegas: lead

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Baylor College of Medicine

Houston, Texas, 77005, United States

Location

Related Publications (41)

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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

• Nora Vanegas, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Neurology

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

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 16, 2018
• Study Start: August 1, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)