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Transdiagnostic Cognitive Biomarkers

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ClinicalTrials.gov Identifier: NCT04864080
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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
Pain Depression Behavioral: Computer game/task Behavioral: Health surveys online Not Applicable

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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Behavioral tasks online and in-person.

Behavioral: Health surveys online
Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.
Other Name: 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 Name: Behavioral tasks online and in-person.

Behavioral: Health surveys online
Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.
Other Name: PHQ-9, MASQ, GAD-7


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility for all aspects of the study [ Time Frame: 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 [ Time Frame: 1-7 days ]
    Sum total of acceptability rating scale of study procedures.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04864080


Contacts
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Contact: David Darrow (612) 624-6666 darro015@umn.edu
Contact: Jeanine Pebbles 6126246666 pebbl002@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: David Darrow    612-624-6666    darro015@umn.edu   
Sponsors and Collaborators
University of Minnesota
More Information
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Publications:
Ekhtiari H, Tavakoli H, Addolorato G, Baeken C, Bonci A, Campanella S, Castelo-Branco L, Challet-Bouju G, Clark VP, Claus E, Dannon PN, Del Felice A, den Uyl T, Diana M, di Giannantonio M, Fedota JR, Fitzgerald P, Gallimberti L, Grall-Bronnec M, Herremans SC, Herrmann MJ, Jamil A, Khedr E, Kouimtsidis C, Kozak K, Krupitsky E, Lamm C, Lechner WV, Madeo G, Malmir N, Martinotti G, McDonald WM, Montemitro C, Nakamura-Palacios EM, Nasehi M, Noël X, Nosratabadi M, Paulus M, Pettorruso M, Pradhan B, Praharaj SK, Rafferty H, Sahlem G, Salmeron BJ, Sauvaget A, Schluter RS, Sergiou C, Shahbabaie A, Sheffer C, Spagnolo PA, Steele VR, Yuan TF, van Dongen JDM, Van Waes V, Venkatasubramanian G, Verdejo-García A, Verveer I, Welsh JW, Wesley MJ, Witkiewitz K, Yavari F, Zarrindast MR, Zawertailo L, Zhang X, Cha YH, George TP, Frohlich F, Goudriaan AE, Fecteau S, Daughters SB, Stein EA, Fregni F, Nitsche MA, Zangen A, Bikson M, Hanlon CA. Transcranial electrical and magnetic stimulation (tES and TMS) for addiction medicine: A consensus paper on the present state of the science and the road ahead. Neurosci Biobehav Rev. 2019 Sep;104:118-140. doi: 10.1016/j.neubiorev.2019.06.007. Epub 2019 Jul 2.

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04864080    
Other Study ID Numbers: NEUR-2020-29420
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms