Clinical trial NCT05022147: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
Official title: ENGAGE-PD: Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
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
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Stride Time Coefficient of Variation
timeFrame: During the intervention
measure: Percentage of Time with Tremor Present
timeFrame: During the intervention
measure: Tremor Amplitude
timeFrame: During the intervention
Secondary outcomes:
measure: Total Freezing Time
timeFrame: During the intervention
measure: Freezing Index
timeFrame: During the intervention
measure: Gait Velocity
timeFrame: During the intervention
measure: Step Cadence
timeFrame: During the intervention
measure: LFP and EEG power spectrum correlation with behavior and kinematics
timeFrame: During the intervention
measure: LFP and EEG connectivity correlation with behavior and kinematics
timeFrame: During the intervention
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: James Liao, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: