Transdiagnostic Cognitive Biomarkers

Sponsor
University of Minnesota (Other)
Overall Status
Recruiting
CT.gov ID
NCT04864080
Collaborator
(none)
45
1
2
46.7
1

Study Details

Study Description

Brief Summary

The overall objective of this study is to determine the feasibility of identifying transdiagnostic biomarkers of cognitive function mediated by neuromodulation of the dorsolateral prefrontal cortex that are translatable across disease groups in order to more accurately phenotype clusters of cognitive dysfunction. Completing behavioral paradigms with electrophysiology and TMS is a challenging frontier. This study focuses on the feasibility of such an endeavor for those with chronic pain or depression as well as healthy controls.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computer game/task
  • Behavioral: Health surveys online
N/A

Detailed Description

This study aims to test the feasibility of procedures aimed at discovering transdiagnostic biomarkers for cognitive impairment in chronic pain and depression. Fifteen healthy control participants and 15 participants from each disease group (chronic pain, depression) will be recruited.

Using a task-based fmri, TMS will be targeted for priming of the Left DLPFC. EEG will be used during our behavioral paradigm to compare changes in DLPFC function before and after primed TMS.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Feasibility studyFeasibility study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Transdiagnostic Cognitive Biomarkers
Actual Study Start Date :
Apr 11, 2022
Anticipated Primary Completion Date :
Mar 1, 2025
Anticipated Study Completion Date :
Mar 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Healthy Comparison Group

Behavioral tasks and surveys online.

Behavioral: Computer game/task
N-back, COGED, PacMan game, Bandit task, Websurf task.
Other Names:
  • Behavioral tasks online and in-person.
  • Behavioral: Health surveys online
    Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.
    Other Names:
  • PHQ-9, MASQ, GAD-7
  • Experimental: Pain/Depression patients from clinic

    MRI, TMS and EEG, and behavioral tasks and surveys online.

    Behavioral: Computer game/task
    N-back, COGED, PacMan game, Bandit task, Websurf task.
    Other Names:
  • Behavioral tasks online and in-person.
  • Behavioral: Health surveys online
    Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.
    Other Names:
  • PHQ-9, MASQ, GAD-7
  • Outcome Measures

    Primary Outcome Measures

    1. Feasibility for all aspects of the study [1-7 days]

      Feasibility; the overall objective of this study is to determine the feasibility of identifying transdiagnostic biomarkers of cognitive function mediated by neuromodulation of the dorsolateral prefrontal cortex that are translatable across disease groups in order to more accurately phenotype clusters of cognitive dysfunction. Completing behavioral paradigms with electrophysiology and TMS is a challenging frontier. This study focuses on the feasibility of such an endeavor for those with chronic pain or depression as well as healthy controls.

    Secondary Outcome Measures

    1. Acceptability [1-7 days]

      Sum total of acceptability rating scale of study procedures.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Arm 1, healthy controls:
    Inclusion Criteria:
    • Have access to the online study platform.
    Exclusion Criteria:
    • under 18, non-English speaking
    Arm 2: pain and depression:
    Inclusion Criteria:
    • Pain or depression
    Exclusion Criteria:
    • 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

    Responsible Party:
    University of Minnesota
    ClinicalTrials.gov Identifier:
    NCT04864080
    Other Study ID Numbers:
    • NEUR-2020-29420
    First Posted:
    Apr 28, 2021
    Last Update Posted:
    May 3, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2022