Parkinson DiseaseNCT06829342
Stochastic Resonance Stimulation Effect on Gait Stability in Parkinson Disease
A study testing Stochastic Resonance (SR) in people with Parkinson Disease, run by University of Delaware at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Stochastic Resonance (SR)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 13 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Sensory Deficits in the Neural Control of Balance During Walking in Parkinson's 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.
- Conditions
- Parkinson Disease
- Being tested
- Stochastic Resonance (SR)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Stochastic Resonance (SR) | Experimental | During this condition, participants will walk on the treadmill while receiving SR stimulation at their individual optimal intensity (SR) with and without visual perturbations. Receives: Device: Stochastic Resonance (SR) |
| No Stochastic Resonance (no-SR) | No intervention | During this condition, participants will walk on the treadmill while receiving no SR stimulation (no-SR) with and without visual perturbations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Center of Mass (CoM) excursion
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.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start19 May 2021
- Primary completion13 Dec 2022
- Study completion13 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's Foundation
- Responsible party
- Sponsor
- Investigators
- John J Jeka, PhD, Study director, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829342
- Sponsor's protocol ID
- 1759595-5
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alsaqabi E, DiBianca S, Sansare A, Verma K, Reimann H, Jeka J. Stochastic resonance stimulation effect on stability during walking in people with Parkinson disease. Int Biomech. 2025 Dec;12(1):81-94. doi: 10.1080/23335432.2025.2584665. Epub 2025 Nov 6.
PubMed 41195808
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sensory Deficits in the Neural Control of Balance During Walking in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06829342
- Acronym / sponsor ID
- 1759595-5
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Parkinson's Foundation
- Study start
- 19 May 2021 (actual)
- Primary completion
- 13 Dec 2022 (actual)
- Study completion
- 13 Dec 2022 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stochastic Resonance (SR) | Experimental | Device: 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. |
| No Stochastic Resonance (no-SR) | No intervention | –During this condition, participants will walk on the treadmill while receiving no SR stimulation (no-SR) with and without visual perturbations. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Stochastic Resonance (SR) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Derived from this study: PubMed 41195808Alsaqabi E, DiBianca S, Sansare A, Verma K, Reimann H, Jeka J. Stochastic resonance stimulation effect on stability during walking in people with Parkinson disease. Int Biomech. 2025 Dec;12(1):81-94. doi: 10.1080/23335432.2025.2584665. Epub 2025 Nov 6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John J Jeka, PhD study director
University of Delaware
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stochastic Resonance (SR) in people with Parkinson Disease, run by University of Delaware at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Center of Mass (CoM) excursion (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06829342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.