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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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. Explore the effects of two SCS programming paradigms on motor, nonmotor and quality of life measures in PD patients with freezing of gait.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
United States
New York
Columbia University
RECRUITING
New York
Texas
Baylor College of Medicine
RECRUITING
Houston
Contact Information
Primary
Nora Vanegas, MD
Nora.VanegasArroyave@bcm.edu
713-798-2273
Backup
Rory Mahabir
rory.mahabir@bcm.edu
713-798-5989
Time Frame
Start Date: 2021-08-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 10
Treatments
Experimental: Spinal Cord Stimulation (SCS) Tonic stimulation
Tonic stimulation
Experimental: Spinal Cord Stimulation (SCS) Burst stimulation
Burst stimulation.
Related Therapeutic Areas
Sponsors
Leads: Nora Vanegas

This content was sourced from clinicaltrials.gov