Adaptive Neurostimulation to Restore Sleep in Parkinson's Disease

Summary

Parkinson's disease (PD) is a neurodegenerative disorder that leads to both motor and non-motor symptoms. Therapies have been developed that effectively target the motor symptoms. Non-motor symptoms are far more disabling for patients, precede the onset of motor symptoms by a decade, are more insidious in onset, have been less apparent to clinicians, and are less effectively treated. Sleep dysfunction is oftentimes the most burdensome of the non-motor symptoms. There are limited options for treating sleep dysfunction in PD, and the mainstay of therapy is the use of sedative-hypnotic drugs without addressing the underlying mechanisms. Patients with PD who demonstrate significant motor fluctuations and dyskinesia are considered for subthalamic nucleus (STN) deep brain stimulation (DBS) surgery. Several studies have reported that STN-DBS also provides benefit for sleep dysregulation. Additionally, local field potentials recorded from STN DBS electrodes implanted for the treatment of PD, have led to the identification of unique patterns in STN oscillatory activity that correlate with distinct sleep cycles, offering insight into sleep dysregulation. This proposal will leverage novel investigational DBS battery technology (RC+S Summit System; Medtronic) that allows the exploration of sleep biomarkers and prototyping of closed-loop stimulation algorithms, to test the hypothesis that STN contributes to the regulation and disruption of human sleep behavior and can be manipulated for therapeutic advantage. Specifically, in PD patients undergoing STN-DBS, the investigators will determine whether STN oscillations correlate with sleep stage transitions, then construct and evaluate sensing and adaptive stimulation paradigms that allow ongoing sleep-stage identification, and induce through adaptive stimulation an increase in duration of sleep stages associated with restorative sleep.

Conditions

• Parkinson Disease
• Sleep Fragmentation

Interventions

DEVICE

Sub-clinical stimulation

The third night of recording will involve sub-clinical thresholds of stimulation in all subjects.

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• University of Colorado, Denver

  collaborator OTHER

• University of Nebraska

  lead OTHER

Principal Investigators

• Aviva Abosch, MD, PhD · University of Nebraska

• Casey Halpern, MD · Stanford University

• Clete Kushida, MD, PhD · Stanford University

• John Thompson, PhD · University of Colorado, Denver

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-10-21

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Device

Yes

Countries

• United States

Study Locations