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

NCT07110376 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-15

No results posted yet for this study

Summary

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

Conditions

  • Parkinson Disease

Interventions

OTHER

Nighttime Deep Brain Stimulation with Varying Amplitude Settings

Participants will undergo three different nighttime-only Deep Brain Stimulation (DBS) settings in a randomized crossover design: 0% amplitude (stimulation off), 50% amplitude of their optimal clinical DBS settings, and full clinical DBS settings (100%). Each setting is applied for two weeks during sleep, over a total six-week home monitoring period. The intervention is designed to assess how varying levels of subthalamic nucleus DBS influence sleep quality and neural oscillatory activity. Only nighttime DBS settings are modified; daytime settings remain unchanged.

Sponsors & Collaborators

  • American Parkinson's Disease Association, Inc

    collaborator OTHER

  • Beacon Biosignals

    collaborator INDUSTRY

  • The Cleveland Clinic

    lead OTHER

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-22
Primary Completion
2026-07-01
Completion
2026-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110376 on ClinicalTrials.gov