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NCT Number: NCT06464029

Pathways Mediating Impaired Postural Control in Parkinson's Disease

The purpose of this project is to use transcranial magnetic stimulation (TMS) to explore the state of excitability of corticocortical and corticofugal (cortex to spinal cord, cortex to brainstem to spinal cord) pathways that project to muscles that control the legs and trunk in people with Parkinson's disease. The outcome variables will be further analyzed to understand their relationship to quantitative measures of postural instability and gait dysfunction. As such, the project can be classified as basic physiologic research. The protocol is not designed to determine if measures of corticocortical or corticofugal excitability can be used as a biomarker to predict disease progression.

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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

45 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Participants with Parkinson's disease

  • Diagnosis of idiopathic PD or dystonia as determined by a movement disorders neurologist in accordance with the UK Society Brain Bank diagnostic criteria.
  • Age 45-80 years.
  • Able to ambulate independently without the use of an assistive device (e.g. cane) for 50 meters.

Healthy Older Adults (Control participants)

  • Age 45-80 years (this group will be age and sex-matched to the PD group)
  • Able to ambulate independently without the use of an assistive device (cane or walker)

Healthy Young Adults

  • Age 21-44 years (this group will be age and sex-matched to the PD group)
  • Able to ambulate independently without the use of an assistive device (cane or walker)

Exclusion criteria

  • Subjects who describe a history of a frequent vasovagal syncope (fainting) in response to blood, emotional stress, or sensory triggers.
  • Subjects who are on anti-coagulant medications.
  • Any musculoskeletal disorder that affects the ability to stand.
  • History of seizures, epilepsy, stroke, multiple sclerosis, or traumatic brain injury.
  • Intracranial metallic or magnetic devices.
  • Pacemaker or any implanted device.
  • History of surgery on blood vessels, brain or heart.
  • Unexplained, recurring headaches or concussion within the last six months.
  • Moderate to severe hearing impairment.
  • Subjects who are pregnant.
  • Dementia diagnosis
  • Other significant neurological disorders that may affect participation or performance in the study
  • Implanted deep brain stimulator or other neurosurgeries to treat PD.

Treatment and study plan

Primary outcomes

  1. average gate speed

    Time frame: baseline

    Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.

  2. stride length

    Time frame: baseline

    Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.

  3. cadence

    Time frame: baseline

    Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.

  4. turn speed

    Time frame: baseline

    Participants will walk on an overground pressure walkway (GAITRite, Franklin, NJ) that provides spatiotemporal measures of walking. In addition, they will wear a set of wearable sensors (APDM Inc., Opals) attached to the feet, wrists and trunk (lumbar and sternum) to capture whole-body motion.

  5. ankle rigidity

    Time frame: 25mins

    Quantitative measures of rigidity will be obtained using a custom-built robotic manipulandum. The manipulandum moves the ankle through a sinusoidal or triangular range of motion (25 deg of plantar flexion to 5 degrees of dorsiflexion; modified as needed for participant's range of motion) while measuring the resistive torque generated by ankle impedance.

  6. Root mean square of the excursion of the center of pressure

    Time frame: 5mins

    Participants will stand on a set of force platforms that measures the forces and pressures beneath the feet. Primary outcome

  7. single pulse TMS

    Time frame: 1.5hrs

    A measure of the excitability of corticospinal pathways. Primary outcome variables: Peak-to-peak amplitude of the motor evoked potential (MEP) responses to TMS in lower limb and trunk muscles.

  8. Paired-Pulse TMS (Intracortical excitability):

    Time frame: 1hr

    A measure of the excitability of intracortical (motor cortex-motor cortex) inhibitory (short-intracortical inhibition, SICI) and excitatory (short-intracortical inhibition, ICF) networks.

    Primary outcome variables: Peak-to-peak amplitude of the motor evoked potential (MEP) responses to TMS in lower limb and trunk muscles.

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua De Kam

CONTACT

[email protected]

612-626-8052

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2024
Registry last updated
Jul 2, 2026

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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