Udall Project 1 Aim 4

April 1, 2024 updated by: University of Minnesota

Assessing Movement Disorder Patients

Non-randomized data collection, excepting participants completing the "Implanted DBS Structured Data Collection", who will be randomized to one of two conditions.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Patients with movement disorders, for example Parkinson's disease (PD), essential tremor (ET) and dystonia, will be assessed using appropriate clinical and (sensor) quantified measures in order to obtain quantitative and qualitative data that is not consistently obtained in clinical exams. This data will aid in assessing trends and outcomes in motor and non-motor signs, side effects and symptoms that correlate with deep brain stimulation (DBS) lead location, stimulation parameters, and other variables, for those that have received this treatment, in order to inform neurosurgical and neurological practices aimed at optimizing treatment and therapy for movement disorders.

For those patients that have received DBS lead implant(s), this study will include the analysis of patient's clinical and/or research-related intraoperative neurophysiological recordings collected during the microelectrode recording portion of the DBS lead implant surgery. Additionally, researchers may analyze trends and outcomes by gathering data from retrospective and prospective chart review

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota

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.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Potential participants are identified by clinicians and trained research personnel through the movement disorder clinic. Patients are identified during the University of Minnesota DBS surgery candidacy evaluation process.

Description

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Group 1

Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions:

  1. clinically-optimized stimulation
  2. model-based stimulation directed towards motor subregions of STN and GPi
  3. model-based stimulation directed towards associative/limbic subregions of STN/GPi

Randomized to start with condition1 assessment
Group 2

Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions:

  1. clinically-optimized stimulation
  2. model-based stimulation directed towards motor subregions of STN and GPi
  3. model-based stimulation directed towards associative/limbic subregions of STN/GPi

Randomized to start with condition 2 assessment
Group 3

Patients will make one visit to the M Health Clinical Research Unit (CRU) after overnight withdrawal of PD medications (still on-DBS) and undergo motor and cognitive assessments in the following three conditions:

  1. clinically-optimized stimulation
  2. model-based stimulation directed towards motor subregions of STN and GPi
  3. model-based stimulation directed towards associative/limbic subregions of STN/GPi

Randomized to start with condition 3 assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months post surgery
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.
6 months post surgery
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.
6 months post surgery
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
6 months post surgery
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.
6 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: Jerrold Vitek, MD, PhD, 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 Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2035

Study Registration Dates

First Submitted

September 26, 2022

First Submitted That Met QC Criteria

October 2, 2022

First Posted (Actual)

October 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007781

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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