RECRUITING

Udall Project 2 Aim 2A&C

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This protocol will leverage the novel (on-label, FDA-approved) local field potential measuring capability of the Medtronic Percept™ PC or RC DBS system to study the effects of globus pallidus internus, globus pallidus externus (GPi, GPe), and subthalamic nucleus (STN) DBS on: the wash-out and wash-in dynamics of motor behavior and local field potentials (LFPs) and correlations between fluctuations in gait and LFPs during activities of daily living (recorded over a minimum of 4 weeks). These experiments will elucidate the relationships between LFPs oscillations, lower limb function, postural control and gait performance.

Official Title

Mechanisms and Effects of Pallidal Deep Brain Stimulation on Levodopa Resistant Motor Signs in Parkinson's Disease; Udall Project 2 Aim 2A&C

Quick Facts

Study Start:2023-01-01
Study Completion:2027-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05656586

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Receiving DBS therapy in GP for treatment of PD
  2. * Implanted with Medtronic Percept DBS system
  3. * At least 3 months since initial activation of the neurostimulator
  4. * For the "At Home" experiment only: participants with DBS settings that are sensing compatible.
  1. * history of musculoskeletal disorders that significantly affects the ability to perform the motor tasks in the specific experiment in question
  2. * history of dementia or cognitive impairment
  3. * other significant neurological disorder as determined by the PI
  4. * post-operative complications or adverse effects (e.g. ON stimulation dystonias) that affect patient safety or confound the experiment
  5. * lack of capacity to consent (as identified by MaCAT-CR)

Contacts and Locations

Study Contact

Colum Mackinnon, PhD
CONTACT
612-625-8938
cmackinn@umn.edu

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55414
United States

Collaborators and Investigators

Sponsor: University of Minnesota

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2027-03-01

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2027-03-01

Terms related to this study

Additional Relevant MeSH Terms

  • Parkinson Disease