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Recruiting

NCT Number: NCT05568199

Udall Project 1 Aim 4

By defining the strength and direction of connectivity patterns at rest and during movement across the basal ganglia-thalamocortical (BGTC) network we will characterize the role of individual circuits in motor performance and cognitive function, paving the way for future development of optimization algorithms for DBS that take advantage of this understanding.

Recruiting

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Key information

Conditions

Parkinsons Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Deep Brain Stimulation Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Of Minnesota

Minneapolis, Minnesota, 55455, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Implanted with a DBS system
  • Existing 7T imagery (either done as standard-of-care or done as part of Noam Harel's study, IRB #1210M22183)
  • Diagnosed with idiopathic Parkinson's Disease
  • Minimum age 21 years

Exclusion criteria

  • Other significant neurological disorder, as determined by PI
  • Diagnosis of dementia
  • Pregnant

Treatment and study plan

Primary outcomes

  1. Motor association with pathway activation patterns

    Time frame: 6 months post surgery

    associate pathway activation patterns with motor (UPDRS-III) outcome obtained during standard of care and research appointments.

  2. Cognitive outcome 1 association with pathway activation pattern

    Time frame: 6 months post surgery

    associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.

    One primary cognitive outcome measure will be the D-KEFS Letter Fluency test. Another primary cognitive measure will be the Stroop Color Word total score. Secondary measures will include the Beck Depression Inventory (BDI)-II and Apathy Scale total scores.

  3. Cognitive outcome 2 association with pathway activation pattern

    Time frame: 6 months post surgery

    associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.

    cognitive measure will be the Stroop Color Word total score.

  4. Cognitive outcome 3 association with pathway activation pattern

    Time frame: 6 months post surgery

    associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.

    cognitive measure will include the Beck Depression Inventory (BDI)-II

  5. Cognitive outcome 4 association with pathway activation pattern

    Time frame: 6 months post surgery

    associate pathway activation patterns with cognitive outcome obtained during standard of care and research appointments.

    cognitive measure will include the Apathy Scale total scores.

Study contacts

Contact information is provided by the study sponsor or research team.

Niecy Beltz

CONTACT

[email protected]

612-626-5711

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 5, 2022
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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