Transdiagnostic Cognitive Biomarkers
Primary Purpose
Pain, Depression
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer game/task
Health surveys online
Sponsored by
About this trial
This is an interventional diagnostic trial for Pain
Eligibility Criteria
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
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Healthy Comparison Group
Pain/Depression patients from clinic
Arm Description
Behavioral tasks and surveys online.
MRI, TMS and EEG, and behavioral tasks and surveys online.
Outcomes
Primary Outcome Measures
Feasibility for all aspects of the study
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
Acceptability
Sum total of acceptability rating scale of study procedures.
Full Information
NCT ID
NCT04864080
First Posted
January 20, 2021
Last Updated
March 8, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT04864080
Brief Title
Transdiagnostic Cognitive Biomarkers
Official Title
Transdiagnostic Cognitive Biomarkers
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 11, 2022 (Actual)
Primary Completion Date
March 1, 2025 (Anticipated)
Study Completion Date
March 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Depression
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Comparison Group
Arm Type
Active Comparator
Arm Description
Behavioral tasks and surveys online.
Arm Title
Pain/Depression patients from clinic
Arm Type
Experimental
Arm Description
MRI, TMS and EEG, and behavioral tasks and surveys online.
Intervention Type
Behavioral
Intervention Name(s)
Computer game/task
Other Intervention Name(s)
Behavioral tasks online and in-person.
Intervention Description
N-back, COGED, PacMan game, Bandit task, Websurf task.
Intervention Type
Behavioral
Intervention Name(s)
Health surveys online
Other Intervention Name(s)
PHQ-9, MASQ, GAD-7
Intervention Description
Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.
Primary Outcome Measure Information:
Title
Feasibility for all aspects of the study
Description
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.
Time Frame
1-7 days
Secondary Outcome Measure Information:
Title
Acceptability
Description
Sum total of acceptability rating scale of study procedures.
Time Frame
1-7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Darrow
Phone
(612) 624-6666
Email
hdlab@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
MATTHEW D Maple
Phone
612-946-1424
Email
maple036@umn.edu
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Darrow
Phone
612-946-1424
Email
hdlab@umn.edu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Transdiagnostic Cognitive Biomarkers
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