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Active, Not Recruiting

NCT Number: NCT05022147

Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Parkinson Disease Accidental Fall Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deep Brain Stimulation Disease Attributes Disease Progression Gait Disorders, Neurologic Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Subthalamic Nucleus Synucleinopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

Postural instability, gait impairment, and falls are among the greatest unmet needs in Parkinson disease (PD). A single fall can be catastrophic, and impairments that limit mobility lead to social isolation or depression, and adversely affect bone and cardiovascular health. Unfortunately, postural instability and gait disorders are refractory to current pharmacological and surgical treatments, including deep brain stimulation (DBS). This project will directly address this pressing need. We will recruit participants to perform a gait task, using a new, alternating DBS frequency paradigm, while body movements and neural signals are recorded. The findings will lead to improved therapies to address these symptoms in the future.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Bilateral STN DBS for PD
  • Medtronic Percept PC implanted DBS battery/pulse generator/recording system
  • Presence of balance and/or walking impairment and/or freezing of gait
  • Can walk without assistance, OFF meds, based on yes/no verbal response

Exclusion criteria

  • Severity of gait impairment should not require dependency to walker or cane
  • Cannot tolerate monopolar stimulation at either of the two middle electrode contacts (prerequisite for the recording mode of the DBS) at high frequency (130 Hz) or low frequency (60 Hz).
  • Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases
  • Contraindication to physical therapy
  • Age < 21
  • Diagnosis of dementia
  • Not agreeable to having video taken of entire research visit

Treatment and study plan

High-Frequency-Only Stimulation

Device

Control condition, constant high-frequency DBS stimulation (130Hz)

Low-Frequency-Only Stimulation

Device

Experimental condition, constant low-frequency DBS stimulation (60 Hz)

Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation

Device

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 10 seconds for low, respectively.

Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation

Device

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 50 seconds for low, respectively.

Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation

Device

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 50 seconds for low, respectively.

Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation

Device

Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 10 seconds for low, respectively.

OFF Dopaminergic Medication

Drug

All six device interventions will be performed in medication OFF state

ON Dopaminergic Medication

Drug

All six device interventions will be performed in medication ON state

Primary outcomes

  1. Stride Time Coefficient of Variation

    Time frame: During the intervention

    Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.

  2. Percentage of Time with Tremor Present

    Time frame: During the intervention

    Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.

  3. Tremor Amplitude

    Time frame: During the intervention

    Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.

Secondary outcomes

  1. Total Freezing Time

    Time frame: During the intervention

    Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.

  2. Freezing Index

    Time frame: During the intervention

    Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.

  3. Gait Velocity

    Time frame: During the intervention

    Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.

  4. Step Cadence

    Time frame: During the intervention

    Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.

  5. LFP and EEG power spectrum correlation with behavior and kinematics

    Time frame: During the intervention

    Neural recordings (LFP = Local Field Potential and EEG = Electroencephalogram) from the DBS electrode and from EEG electrodes will be analyzed in the frequency domain. Assessed frequency bands will include delta, theta, alpha, beta, and gamma activity. These will be correlated with behavior and kinematic recordings to determine the neural correlates of gait instability and other parkinsonian symptoms.

  6. LFP and EEG connectivity correlation with behavior and kinematics

    Time frame: During the intervention

    Neural recordings (LFP = Local Field Potential and EEG = Electroencephalogram) consist of multiple channels of simultaneously measured electrical activity. Connectivity is a measure of correlations between each pair of recorded and postprocessed channels, at each frequency band, over time. A machine learning algorithm will be trained to correlate the connectivity to behavior and kinematic recordings, to determine the neural correlates of gait instability and other parkinsonian symptoms.

Sponsors and collaborators

Lead sponsor

James Liao

Other

Registry information

Official study title

ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

Acronym: ENGAGE-PD

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Aug 26, 2021
Registry last updated
Jul 1, 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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