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

James Liao

Status and phase: Enrolling; Phase 1

Conditions: Gait Disorders, Neurologic; Subthalamic Nucleus; Disease Progression; Parkinson Disease; Deep Brain Stimulation; Accidental Fall

Treatments: Device: Low-Frequency-Only Stimulation; Drug: ON Dopaminergic Medication; Device: High-Frequency-Only Stimulation; Device: Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation; Device: Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation; Device: Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation; Drug: OFF Dopaminergic Medication; Device: Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05022147

21-739

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Alternating-Frequency DBS

Experimental group

Description:

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

Treatment:

Drug: OFF Dopaminergic Medication

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, 10 sec Low-Frequency Stimulation

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

Drug: ON Dopaminergic Medication

Device: High-Frequency-Only Stimulation

Device: Low-Frequency-Only Stimulation