Stochastic Resonance Stimulation Effect on Gait Stability in Parkinson Disease

NCT ID: NCT06829342

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2022-12-13

Brief Summary

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Stochastic Resonance (SR)

During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations.

Group Type: EXPERIMENTAL

Stochastic Resonance (SR)

Intervention Type: 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.

No Stochastic Resonance (no-SR)

During this condition, participants will walk on the treadmill while receiving no SR stimulation (no-SR) with and without visual perturbations.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stochastic Resonance (SR)

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkinson's Foundation

OTHER

Sponsor Role: collaborator

University of Delaware

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John J Jeka, PhD

Role: STUDY_DIRECTOR

University of Delaware

Locations

University of Delaware

Newark, Delaware, United States

Countries

United States

Other Identifiers

1759595-5

Identifier Type: -

Identifier Source: org_study_id