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Device

Spinal Cord Stimulation for Parkinson's Disease (SCS for FOG Trial)

N/A
Recruiting
Led By Nora Vanegas, MD
Research Sponsored by Nora Vanegas-Arroyave
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Optimized PD treatment including dopaminergic medications and/or deep brain stimulation (DBS) therapy
Must not have
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 psychosis, Depression BDI >14, Anxiety BAI >14)
Diagnosis of failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS), or intractable low back pain and leg pain
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12-months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess the effectiveness of SCS for treating FOG in PD patients. The investigators hope to find that SCS decreases the number of FOG episodes experienced by patients with PD.

Who is the study for?
This trial is for adults over 18 with Parkinson's Disease who have optimized their treatment but still experience at least two episodes of freezing gait daily that don't improve with medication. They must meet specific criteria for PD diagnosis and be able to consent. Excluded are those with certain psychiatric illnesses, uncontrolled medical conditions, or on anticoagulants they can't stop before the procedure.
What is being tested?
The study tests if spinal cord stimulation (SCS) can reduce episodes of freezing gait in Parkinson's patients when standard treatments fail. It will compare two SCS programming methods to see how they affect motor skills, nonmotor symptoms, and life quality.
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of SCS may include discomfort at the implant site, unwanted tingling or sensations due to electrical impulses, infection risk from surgery, and possible changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I experienced freezing while moving, even after taking my regular Levodopa dose.
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I am receiving the best possible treatment for Parkinson's, including medications or DBS.
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I have Parkinson's with symptoms not improved by levodopa, including slow movement, tremor, or stiffness.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe mental health issues that could affect my study participation.
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I have severe, ongoing pain in my back or leg after surgery, or I have CRPS.
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I do not have an active infection, uncontrolled diabetes, or conditions that weaken my immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12-months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability
Secondary study objectives
10-meter walk
Change in MDS-UPDRS score
Change in New Freezing of Gait Questionnaire (NFOG-Q) score
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Spinal Cord Stimulation (SCS) Tonic stimulationExperimental Treatment1 Intervention
Tonic stimulation
Group II: Spinal Cord Stimulation (SCS) Burst stimulationExperimental Treatment1 Intervention
Burst stimulation.

Find a Location

Who is running the clinical trial?

Nora Vanegas-ArroyaveLead Sponsor
Nora VanegasLead Sponsor
1 Previous Clinical Trials
10 Total Patients Enrolled
Nora Vanegas, MDPrincipal InvestigatorBaylor College of Medicine

Media Library

Spinal Cord Stimulator (SCS) (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03526991 — N/A
Parkinson's Disease Research Study Groups: Spinal Cord Stimulation (SCS) Burst stimulation, Spinal Cord Stimulation (SCS) Tonic stimulation
Parkinson's Disease Clinical Trial 2023: Spinal Cord Stimulator (SCS) Highlights & Side Effects. Trial Name: NCT03526991 — N/A
Spinal Cord Stimulator (SCS) (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03526991 — N/A
Parkinson's Disease Patient Testimony for trial: Trial Name: NCT03526991 — N/A
~2 spots leftby Jun 2025
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