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

Trial ID: NCT05022147

Interventional - Phase 1 - Active, not recruiting

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

Interventions

• 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
• Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation
• OFF Dopaminergic Medication
• ON Dopaminergic Medication

Eligibility

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

Sponsor

James Liao

Source: ClinicalTrials.gov

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