Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

October 4, 2021

Primary Completion Date

November 15, 2024

Study Completion Date

November 30, 2025

Conditions
Parkinson DiseaseGait Disorders, NeurologicDisease ProgressionSubthalamic NucleusAccidental FallDeep Brain Stimulation
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

Trial Locations (1)

44195

Cleveland Clinic Foundation, Cleveland

All Listed Sponsors
lead

James Liao

OTHER