Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07110376

Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease

Led by The Cleveland Clinic · Updated on 2025-12-15

10

Participants Needed

1

Research Sites

57 weeks

Total Duration

On this page

Sponsors

T

The Cleveland Clinic

Lead Sponsor

A

American Parkinson's Disease Association, Inc

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study employs an exploratory, prospective, single center, naturalistic clinical trial design with a randomized crossover intervention.

CONDITIONS

Official Title

Deep Brain Stimulation Neural Recordings of Varied Stimulation During Sleep in Parkinson's Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female over 18 years of age
  • Diagnosed with idiopathic Parkinson Disease
  • Have bilateral implantation of Medtronic's PerceptTM PC Deep Brain Stimulation system targeting the subthalamic nucleus
  • Have had DBS stimulation settings optimized for at least three months
  • Report a response score of one or greater on question 1.7 of the MDS-UPDRS part I
  • Able to walk independently
  • Capable of providing informed consent
  • If taking sleep-supporting medications, dosing must be stable for at least 30 days
Not Eligible

You will not qualify if you...

  • Have neurological diseases other than Parkinson Disease, such as stroke or multiple sclerosis
  • Have active sleep disorders like narcolepsy, moderate to severe untreated sleep apnea (Apnea-Hypopnea Index ≥15), or uncontrolled restless legs syndrome
  • Have cognitive impairment meeting criteria for dementia based on formal neuropsychological evaluation
  • Have ongoing alcohol or substance abuse
  • Work night shifts or have irregular work hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cleveland Clinic

Cleveland, Ohio, United States, 441950001

Actively Recruiting

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Research Team

S

Saar Anis, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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