Parkinson DiseasePhase 1ENGAGE-PDNCT05022147
Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
A Phase 1 study testing High-Frequency-Only Stimulation, Low-Frequency-Only Stimulation and Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by James Liao at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Parkinson Disease, Gait Disorders, Neurologic, Disease Progression
- What is being tested?
- High-Frequency-Only Stimulation, Low-Frequency-Only Stimulation and Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: ENGAGE-PD: 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).
Read the detailed description
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.
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic, Disease Progression, Subthalamic Nucleus, Accidental Fall, Deep Brain Stimulation
- Being tested
- High-Frequency-Only Stimulation, Low-Frequency-Only Stimulation, Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation, Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation, Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation
- Keywords
- Postural Instability, Gait Impairment, Freezing of Gait, DBS, Frequency, Low, Alternating, Variable, High
- Medical subject headings
- Parkinson Disease, Gait Disorders, Neurologic, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Frequency-Only StimulationDevice
Control condition, constant high-frequency DBS stimulation (130Hz)
Low-Frequency-Only StimulationDevice
Experimental condition, constant low-frequency DBS stimulation (60 Hz)
Alternating, 50 sec High-Frequency, 10 sec Low-Frequency StimulationDevice
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 StimulationDevice
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 StimulationDevice
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 StimulationDevice
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 MedicationDrug
All six device interventions will be performed in medication OFF state
ON Dopaminergic MedicationDrug
All six device interventions will be performed in medication ON state
| Study group | Role | What they receive |
|---|---|---|
| Alternating-Frequency DBS | Experimental | In this single-arm study, all participants will receive all interventions in a crossover fashion. Receives: Device: High-Frequency-Only Stimulation; Device: Low-Frequency-Only Stimulation; Device: Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation; Device: Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation; Device: Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation; Device: Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation; Drug: OFF Dopaminergic Medication; Drug: ON Dopaminergic Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stride Time Coefficient of Variation
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Measured: During the intervention
Percentage of Time with Tremor Present
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Measured: During the intervention
Tremor Amplitude
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Measured: During the intervention
Secondary outcomes (6)
Total Freezing Time
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Measured: During the intervention
Freezing Index
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Measured: During the intervention
Gait Velocity
Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.
Measured: During the intervention
Step Cadence
Marker of bradykinesia, derived from kinematic recordings from body-worn wireless sensors.
Measured: During the intervention
LFP and EEG power spectrum correlation with behavior and kinematics
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.
Measured: During the intervention
LFP and EEG connectivity correlation with behavior and kinematics
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.
Measured: During the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start4 Oct 2021
- Primary completion15 Nov 2024
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- On a single day, participants will switch between six DBS frequency conditions. Gait and body kinematics will be monitored during these conditions. The order that participants experience the six conditions will be randomized, and participants will be blinded to the condition. In addition, the assessments will be performed OFF and then repeated ON medication.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- James Liao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, James Liao, The Cleveland Clinic
- Investigators
- James Liao, MD PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022147
- Sponsor's protocol ID
- 21-739
- Acronym
- ENGAGE-PD
- Status last verified
- Sep 2025
- First submitted
- 9 Aug 2021
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: At time of publication, a point of contact individual on the study team will be identified. Third parties will be able to request access to de-identified data used to support the publication findings by application to the Cleveland Clinic IRB. A data use agreement will be put in place between the CCF Cleveland Clinic and this third party for approved use of the data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
- ClinicalTrials.gov ID
- NCT05022147
- Acronym / sponsor ID
- ENGAGE-PD / 21-739
- Conditions
- Parkinson Disease, Gait Disorders, Neurologic, Disease Progression, Subthalamic Nucleus, Accidental Fall, Deep Brain Stimulation
- Keywords
- Postural Instability, Gait Impairment, Freezing of Gait, DBS, Frequency, Low, Alternating, Variable
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- James LiaoUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 26 Aug 2021 (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 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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- On a single day, participants will switch between six DBS frequency conditions. Gait and body kinematics will be monitored during these conditions. The order that participants experience the six conditions will be randomized, and participants will be blinded to the condition. In addition, the assessments will be performed OFF and then repeated ON medication.
| Arm | Type | Receives |
|---|---|---|
| Alternating-Frequency DBS | Experimental | Device: High-Frequency-Only Stimulation, Device: Low-Frequency-Only Stimulation, Device: Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation, Device: Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation, Device: Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation, Device: Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation, Drug: OFF Dopaminergic Medication, Drug: ON Dopaminergic MedicationIn this single-arm study, all participants will receive all interventions in a crossover fashion. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| High-Frequency-Only StimulationControl condition, constant high-frequency DBS stimulation (130Hz) | Device | Alternating-Frequency DBS |
| Low-Frequency-Only StimulationExperimental condition, constant low-frequency DBS stimulation (60 Hz) | Device | Alternating-Frequency DBS |
| Alternating, 50 sec High-Frequency, 10 sec Low-Frequency StimulationExperimental 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. | Device | Alternating-Frequency DBS |
| Alternating, 50 sec High-Frequency, 50 sec Low-Frequency StimulationExperimental 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. | Device | Alternating-Frequency DBS |
| Alternating, 10 sec High-Frequency, 50 sec Low-Frequency StimulationExperimental 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. | Device | Alternating-Frequency DBS |
| Alternating, 10 sec High-Frequency, 10 sec Low-Frequency StimulationExperimental 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. | Device | Alternating-Frequency DBS |
| OFF Dopaminergic MedicationAll six device interventions will be performed in medication OFF state | Drug | Alternating-Frequency DBS |
| ON Dopaminergic MedicationAll six device interventions will be performed in medication ON state | Drug | Alternating-Frequency DBS |
Primary outcome
Stride Time Coefficient of Variation
Time frame: During the intervention
Marker of gait instability, derived from kinematic recordings from body-worn wireless sensors.
Percentage of Time with Tremor Present
Time frame: During the intervention
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
Tremor Amplitude
Time frame: During the intervention
Marker of tremor severity, derived from kinematic recordings from body-worn wireless sensors.
6 secondary outcomes
Total Freezing Time
Time frame: During the intervention
Freezing Index
Time frame: During the intervention
Gait Velocity
Time frame: During the intervention
Step Cadence
Time frame: During the intervention
LFP and EEG power spectrum correlation with behavior and kinematics
Time frame: During the intervention
LFP and EEG connectivity correlation with behavior and kinematics
Time frame: During the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: Yes. At time of publication, a point of contact individual on the study team will be identified. Third parties will be able to request access to de-identified data used to support the publication findings by application to the Cleveland Clinic IRB. A data use agreement will be put in place between the CCF Cleveland Clinic and this third party for approved use of the data.
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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.
James Liao, MD PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High-Frequency-Only Stimulation, Low-Frequency-Only Stimulation and Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation in people with Parkinson Disease and Gait Disorders, Neurologic, run by James Liao 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 4 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Stride Time Coefficient of Variation (time frame: During the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2026.