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Procedure

Spinal Cord Stimulation for Parkinson's Disease

Louisville, KY

N/A

Recruiting

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Parkinson's disease

Adults aged 18 to 80 years

Must not have

Co-morbidities affecting gait

Current diagnosis or condition such as major cardiac insufficiency, determined clinically by the study doctors

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of screening until the date of data is analyzed, up to 48 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to investigate the use of non-invasive spinal cord stimulation to improve walking difficulties in Parkinson's disease. The study hypothesizes that this stimulation can activate specific networks in the spine, improve

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Who is the study for?

This trial is for individuals with Parkinson's Disease who experience gait dysfunction that isn't well-managed by medication or deep brain stimulation. It's not suitable for those with dementia or other conditions that might interfere with the treatment.Check my eligibility

What is being tested?

The study tests non-invasive spinal cord transcutaneous stimulation (scTS) at various spinal levels to improve walking and balance in Parkinson's patients. It aims to activate locomotor patterns and enhance postural control without surgery.See study design

What are the potential side effects?

While specific side effects are not detailed, scTS is non-invasive, suggesting a lower risk profile compared to surgical options. Potential discomfort or skin irritation at the stimulation site may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Parkinson's disease.

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I am between 18 and 80 years old.

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I can walk 10 meters on my own.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have health conditions that affect my ability to walk.

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My heart is not working well, as confirmed by doctors.

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I cannot communicate with the study team.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of screening until the date of data is analyzed, up to 48 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of screening until the date of data is analyzed, up to 48 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of screening until the date of data is analyzed, up to 48 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

A. Assessment of Multisegmental Motor Responses (MMR)

D. Assessment of Balance and Gait: Tinetti Balance & Gait Test, Rating Instrument to Assess Festination and Freezing Gait, and Push & Release Test

New Freezing of Gait Questionnaire (NFOG-Q)

+6 more

Secondary study objectives

10-Meter Walk Test

6-Minute Walk Test

Modified Ashworth Scale (MAS) and Range of Motion (ROM) Testing

+2 more

Other study objectives

Cognitive Assessment Battery (CAB)

Corticospinal Pathway Assessment (CSPA) with Transcranial Magnetic Stimulation (TMS)

Cutaneomuscular Reflex (CMR)

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Non-invasive spinal neuromodulation trainingExperimental Treatment1 Intervention

The overall strategy outlined in this proposal is based on previous data from our own group reporting gait improvement in SCI individuals through activation of spinal locomotor networks located in the lumbosacral region that bear the capability of generating full weight-bearing stepping when epidural stimulation is combined with transcutaneous stimulation of the cervical spinal cord (Angeli \& Gerasimenko, 2023). Building on our knowledge from SCI patients, the approach in the present study will be to modulate the ascending proprioceptive fibers important for feedback and posture control and to overcome disruptive signals from descending systems, which presumably occur in PD individuals (Sarica et al., 2023), by taking advantage of the intrinsic abilities of the lumbosacral spinal network to generate stepping. This is a prospective non-blinded non-randomized study. All data will be stored for off-line analysis.

0 / 6Eligibility criteria met