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Assessing Movement Disorder Patients P1A4

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT05568199
Collaborator
(none)
200
Enrollment
1
Location
182.6
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessing Movement Disorder Patients
    Actual Study Start Date :
    Oct 13, 2019
    Anticipated Primary Completion Date :
    Jan 1, 2030
    Anticipated Study Completion Date :
    Jan 1, 2035

    Outcome Measures

    Primary Outcome Measures

    1. Unified Parkinson's Disease Rating Scale [6 months]

      pre-to-post DBS lead implantation changes in sign and symptom severity

    2. Burke-Fahn-Marsden Dystonia Rating Scale [6 months]

      pre-to-post DBS lead implantation changes in sign and symptom severity

    3. Tremor Research Group Essential Tremor Rating Scale [6 months]

      pre-to-post DBS lead implantation changes in sign and symptom severity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Diagnosis or suspected diagnosis of Parkinson's disease, Essential Tremor, or Dystonia

    • Aged: 10+

    Exclusion Criteria:

    • History of dementia

    • Patients with post-operative complications or adverse effects that affect patient safety or confound the experiment will be excluded from further study.

    • Pregnant women

    • Lactating 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:
    NCT05568199
    Other Study ID Numbers:
    • STUDY00007781
    First Posted:
    Oct 5, 2022
    Last Update Posted:
    Jan 4, 2023
    Last Verified:
    Jan 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Minnesota
    dystonia
    Parkinsons disease
    essential tremor
    Additional relevant MeSH terms:
    Movement Disorders

    Study Results

    No Results Posted as of Jan 4, 2023