Novel Paradigms of Deep Brain Stimulation for Movement Disorders

Summary

Investigators will enroll patients who are already selected to undergo deep brain stimulation surgery based on standard of care. The surgical implantation of the leads will be based on standard of care and will be completed with FDA-approved leads that are routinely used at Cleveland Clinic. The pulse generators (i.e. the battery) will also be standard. The research will characterize spontaneous and task-related changes in brain activity recorded from these regions alone and in relation to novel paradigms / settings of stimulation to learn how such paradigms impact both the symptoms of patients with Parkinson's disease and the underlying neural activity of the target brain region. Of particular interest is to learn if the novel paradigms of stimulation will have a lower impact on cognitive function than current settings of stimulation.To date, current DBS settings are continuous. That is, stimulation runs at approximately 200 pulses per second, all day long, day and night.

The novel settings that investigators will study are part of a translational pipeline at Cleveland Clinic. Dr. Ken Baker and Dr. Machado are partners in the lab and in clinical research. Dr. Baker has completed preclinical research that has shown that it is possible to achieve excellent relief of parkinsonian symptoms with intermittent types of stimulation known as coordinated reset. In other words, Dr Baker found that using a lower dose of stimulation in an intermittent fashion can maintain the same level of symptom control. Furthermore, a lower dose of stimulation could have less effects on cognitive symptoms.

In order to test these novel paradigms of stimulation, investigators will study patients immediately after DBS and over time. The immediate research will be done starting on the third day after implantation of the DBS lead(s), having the systems externalized for nine days. The long-term research will be conducted with patients already fully implanted and healed from surgery. In addition to evaluating for motor and cognitive tasks using computer based assessments, investigators will utilize non-invasive electrophysiological measures including EEG, EMG, MEG, and wearable accelerometer/gyroscopes to better characterize the effects of stimulation settings.

Conditions

• Parkinson Disease

Interventions

OTHER

Novel DBS Stimulation

Stimulation patterns will vary from the standard therapeutic approach in terms of frequency, contact location, and/or temporal pattern.

Sponsors & Collaborators

• Farmer Foundation

  collaborator UNKNOWN

• The Cleveland Clinic

  lead OTHER

Principal Investigators

• Kenneth Baker, PhD · The Cleveland Clinic

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-17

Primary Completion

2023-09-07

Completion

2023-09-07

Countries

• United States

Study Locations