Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

NCT05022147 | Active Not Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: 21-739
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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).

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; High

Outcome Measures

Primary Outcomes (3)

• Stride Time Coefficient of Variation

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

  During the intervention

• Percentage of Time with Tremor Present

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

  During the intervention

• Tremor Amplitude

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

  During the intervention

Secondary Outcomes (6)

• Total Freezing Time

  During the intervention

• Freezing Index

  During the intervention

• Gait Velocity

  During the intervention

• Step Cadence

  During the intervention

• LFP and EEG power spectrum correlation with behavior and kinematics

  During the intervention

Study Arms (1)

Alternating-Frequency DBS

EXPERIMENTAL

In this single-arm study, all participants will receive all interventions in a crossover fashion.

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

Interventions

High-Frequency-Only Stimulation DEVICE

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

Alternating-Frequency DBS

Low-Frequency-Only Stimulation DEVICE

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

Alternating-Frequency DBS

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-Frequency DBS

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-Frequency DBS

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-Frequency DBS

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.

Alternating-Frequency DBS

OFF Dopaminergic Medication DRUG

All six device interventions will be performed in medication OFF state

Alternating-Frequency DBS

ON Dopaminergic Medication DRUG

All six device interventions will be performed in medication ON state

Alternating-Frequency DBS

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• James Liao: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Gait Disorders, Neurologic; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• James Liao, MD PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: There is only one arm in the study. Participants will be masked to which device intervention is active, but they will not be masked to the medication state.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: August 26, 2021
• Study Start: October 4, 2021
• Primary Completion: November 15, 2024
• Study Completion: May 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)