Stochastic Resonance Stimulation Effect on Gait Stability in Parkinson Disease

The present study explored the use of a technique called stochastic resonance (SR) stimulation that may help individuals with Parkinson Disease maintain balance while walking on challenging surfaces. Impaired balance represents one of the disease symptoms, putting people at risk for falls, partly due to impaired processing of sensory information. SR uses light electrical signals to improve the way the body detects sensations. We wanted to test if SR could help people with Parkinson disease stay steadier while walking. Each participant's optimal SR intensity was determined before they walked on a treadmill in a virtual environment that created visual disturbances to challenge their balance. We measured how much their body swayed, how they placed their feet, and how their ankles moved during the walking tasks.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Delaware

Newark, Delaware, 19713, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of Parkinson Disease
Hoehn and Yahr (H&Y) stage ≤ III
Can walk independently for at least 2 minutes without an assistive device or orthosis
Ability to communicate discomfort during testing
Can follow multi-step commands
Scored at least 24/30 on the Montreal Cognitive assessment (MoCA)

Exclusion criteria

Any head, neck, or face injury in the six months prior to the study (e.g., concussion, eye injury)
History of vestibular or ocular dysfunction
Currently taking any medications affecting balance (i.e. antibiotics)
Injuries to lower extremities affecting balance in the past six months
Pregnancy
Any neurological disorders other than Parkinson's disease (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, history of stroke)
Unstable cardiac or pulmonary disease
Clinically obese (BMI 30 or above)
Any metal implant in the feet or legs that is close to the stimulating electrodes
A known allergy to medical-grade adhesives
Any other comorbidity affecting the ability to safely walk without assistance for at least 2 minutes
Exhibited severe dyskinesia
Did not respond to L-DOPA or other dopaminergic treatment
Exhibited cardiovascular-autonomic or multiple-system symptoms indicative of a "Parkinsonism-plus" presentation

Treatment and study plan

Stochastic Resonance (SR)

Device

The system consists of six linear isolated stimulators (STMISOLA, Biopac Systems, Inc., Goleta, USA). The SR signal (Gaussian White Noise, zero mean) will be generated through a 16 bit PCI 6733 National Instruments multifunction data acquisition card by a custom LabView program. The stimulation sites include the ankle, lateral soleus, peroneus longus, and tibialis anterior muscles and the hip.

Primary outcomes

Change in the Center of Mass (CoM) excursion

Time frame: Through study completion, an average of 1 year.

For the visual perturbation trials, we will use CoM excursion as the primary outcome measure since it has been used in prior studies in children and adults using visual perturbation protocols. This is determined by comparing the average CoM during perturbed steps to non-perturbed steps for each participant, integrated across the first eight steps initiated by the heel strike that triggered the stimulus. We will measure CoM using kinetics and kinematic computed through a motion capture system(Qualysis).

For the unperturbed trials, we will use margin of stability (MoS) as the primary outcome measure. MOS refers to the distance between extrapolated center of mass, which includes center of mass position and velocity, and the base of support. It has been previously used to measure balance in children with cerebral palsy and Parkinson Disease.

Sponsors and collaborators

Lead sponsor

University of Delaware

Other

Collaborators

Parkinson's Foundation

Registry information

Official study title

The Role of Sensory Deficits in the Neural Control of Balance During Walking in Parkinson's Disease

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Feb 17, 2025
Registry last updated: Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed