Transdiagnostic Cognitive Biomarkers

Not Applicable

Recruiting

• Conditions: Depression; Pain
• Interventions: Behavioral: Computer game/task; Behavioral: Health surveys online

• Registration Number: NCT04864080
• Lead Sponsor: University of Minnesota

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-04-26
• Study First Posted: 2021-04-28
• Study Start: 2022-04-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Primary Completion: 2025-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Have access to the online study platform.

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Exclusion Criteria

• under 18, non-English speaking

Arm 2: pain and depression:

Inclusion Criteria:

• Pain or depression

Exclusion Criteria:

• pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Comparison Group	Computer game/task	Behavioral tasks and surveys online.
Healthy Comparison Group	Health surveys online	Behavioral tasks and surveys online.
Pain/Depression patients from clinic	Health surveys online	MRI, TMS and EEG, and behavioral tasks and surveys online.
Pain/Depression patients from clinic	Computer game/task	MRI, TMS and EEG, and behavioral tasks and surveys online.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Acceptability	1-7 days	Sum total of acceptability rating scale of study procedures.

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States