DBS and Sleep Outcomes

• Sponsor: University of Minnesota (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05962489
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Anticipated Duration (Months): 48.2
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

The objective of this study is to describe how activation of distinct pathways in and around the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS) surgery targeting these structures.

Condition or Disease	Intervention/Treatment	Phase
Deep Brain Stimulation; Parkinson's Disease and Parkinsonism; Dystonia	Device: DBS

Study Design

• Study Type: Observational
• Anticipated Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Other
• Official Title: Sleep Outcomes With DBS Therapy in Parkinson's Disease and Dystonia
• Anticipated Study Start Date: Jul 25, 2023
• Anticipated Primary Completion Date: Jul 1, 2026
• Anticipated Study Completion Date: Aug 1, 2027

Outcome Measures

Primary Outcome Measures

1. pallidopeduncular and pedunculopallidal pathway activation [6 months post DBS surgery]

   Percent of pallidopeduncular and pedunculopallidal pathway activation

2. pallidopeduncular and pedunculopallidal pathway activation [12 months post DBS surgery]

   Percent of pallidopeduncular and pedunculopallidal pathway activation

3. GPe activation [6 months post DBS surgery]

   percent of GPe activation

4. GPe activation [12 months post DBS surgery]

   percent of GPe activation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. At least 21 years old

2. Existing or planned 7T brain imaging

3. Surgery at UMN to implant DBS system in GPi or STN 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)

Exclusion Criteria:

1. Other significant neurological disorder

2. History of dementia

3. 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

4. Pregnant women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT05962489
• Other Study ID Numbers: STUDY00018981
• First Posted: Jul 27, 2023
• Last Update Posted: Jul 27, 2023
• Last Verified: Jul 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Dystonia; Dystonic Disorders; Parkinsonian Disorders

Study Results

No Results Posted as of Jul 27, 2023