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ACTIVE NOT RECRUITING
NCT05022147
PHASE1

Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

Sponsor: James Liao

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2021-10-04

Completion Date

2026-05

Last Updated

2026-01-13

Healthy Volunteers

No

Interventions

DEVICE

High-Frequency-Only Stimulation

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

DEVICE

Low-Frequency-Only Stimulation

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

DEVICE

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

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.

DEVICE

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

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.

DEVICE

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

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.

DEVICE

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

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.

DRUG

OFF Dopaminergic Medication

All six device interventions will be performed in medication OFF state

DRUG

ON Dopaminergic Medication

All six device interventions will be performed in medication ON state

Locations (1)

Cleveland Clinic Foundation

Cleveland, Ohio, United States