NCT05962489

Brief Summary

Sleep-wake disturbances are a major factor associated with reduced quality of life of individuals with Parkinson's disease (PD), a progressive neurological disorder affecting millions of people in the U.S and worldwide. The brain mechanisms underlying these sleep disorders, and the effects of therapeutic interventions such as deep brain stimulation on sleep-related neuronal activity and sleep behavior, are not well understood. Results from this study will provide a better understanding of the brain circuitry involved in disordered sleep in PD and inform the development of targeted therapeutic interventions to treat sleep disorders in people with neurodegenerative disease.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
15mo left

Started Jun 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Jun 2023Aug 2027

Study Start

First participant enrolled

June 22, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

March 3, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

June 28, 2023

Last Update Submit

March 2, 2026

Conditions

DystoniaDeep Brain StimulationParkinson's Disease and Parkinsonism

Outcome Measures

Primary Outcomes (8)

  • pallidopeduncular and pedunculopallidal pathway activation

    Percent of pallidopeduncular and pedunculopallidal pathway activation

    6 months post DBS surgery

  • pallidopeduncular and pedunculopallidal pathway activation

    Percent of pallidopeduncular and pedunculopallidal pathway activation

    12 months post DBS surgery

  • GPe activation

    percent of GPe activation

    6 months post DBS surgery

  • GPe activation

    percent of GPe activation

    12 months post DBS surgery

  • Actigraphy

    Actigraphy-based measures of sleep quality

    6 months post DBS surgery

  • Actigraphy

    Actigraphy-based measures of sleep quality

    12 months post DBS surgery

  • Clinical Rating Scales

    Total scores from the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale

    6 months post DBS surgery

  • Clinical Rating Scales

    Total scores from the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale

    12 months post DBS surgery

Study Arms (2)

OFF DBS followed by ON DBS

EXPERIMENTAL
Other: Clinically optimized deep brain stimulation

ON DBS followed by OFF DBS

EXPERIMENTAL
Other: Clinically optimized deep brain stimulation

Interventions

Clinically optimized deep brain stimulationOTHER

Participants will have DBS implanted as standard-of-care. We will be examining the effects of their regular clinical stimulation settings versus no stimulation.

OFF DBS followed by ON DBSON DBS followed by OFF DBS

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of idiopathic PD
  • At least 21 years old
  • Existing or planned 7T brain imaging
  • Surgery at UMN to implant DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care
  • Surgery at UMN to implant bilateral DBS system in GPi or STN with directional lead(s) is planned as part of routine clinical care (or has already occurred, as long as the initial programming session is at least 2 weeks away)

You may not qualify if:

  • Other significant neurological disorder
  • History of dementia
  • Patients with post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment will be excluded from further study
  • Pregnant women
  • Known radiation exposure within the last year that is determined to be unsafe when compounded with the expected radiation dose from intraoperative fluoroscopy to place ECoG strip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian DisordersDystonia

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Emily Weatherill, BS

CONTACT

612-625-4947weath210@umn.edu

Luke Johnson, PhD

CONTACT

612-625-9900joh03032@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2023

First Posted

July 27, 2023

Study Start

June 22, 2023

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

March 3, 2026

Record last verified: 2026-03

Locations

US(1)