Transdiagnostic Cognitive Biomarkers

NCT ID: NCT04864080

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-11

Study Completion Date

2027-03-01

Brief Summary

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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

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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.

Conditions

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Pain Depression

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Feasibility study
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Healthy Comparison Group

Behavioral tasks and surveys online.

Group Type ACTIVE_COMPARATOR

Computer game/task

Intervention Type BEHAVIORAL

N-back, COGED, PacMan game, Bandit task, Websurf task.

Health surveys online

Intervention Type BEHAVIORAL

Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.

Pain/Depression patients from clinic

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

Group Type EXPERIMENTAL

Computer game/task

Intervention Type BEHAVIORAL

N-back, COGED, PacMan game, Bandit task, Websurf task.

Health surveys online

Intervention Type BEHAVIORAL

Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.

Interventions

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Computer game/task

N-back, COGED, PacMan game, Bandit task, Websurf task.

Intervention Type BEHAVIORAL

Health surveys online

Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.

Intervention Type BEHAVIORAL

Other Intervention Names

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Behavioral tasks online and in-person. PHQ-9, MASQ, GAD-7

Eligibility Criteria

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Inclusion Criteria

* Have access to the online study platform.


* Pain or depression

Exclusion Criteria

* under 18, non-English speaking

Arm 2: pain and depression:


* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David Darrow

Role: CONTACT

(612) 624-6666

MATTHEW D Maple

Role: CONTACT

612-946-1424

Facility Contacts

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David Darrow

Role: primary

612-946-1424

References

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Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033.

Reference Type BACKGROUND
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Chung SW, Rogasch NC, Hoy KE, Fitzgerald PB. The effect of single and repeated prefrontal intermittent theta burst stimulation on cortical reactivity and working memory. Brain Stimul. 2018 May-Jun;11(3):566-574. doi: 10.1016/j.brs.2018.01.002. Epub 2018 Jan 8.

Reference Type BACKGROUND
PMID: 29352668 (View on PubMed)

Schicktanz N, Fastenrath M, Milnik A, Spalek K, Auschra B, Nyffeler T, Papassotiropoulos A, de Quervain DJ, Schwegler K. Continuous theta burst stimulation over the left dorsolateral prefrontal cortex decreases medium load working memory performance in healthy humans. PLoS One. 2015 Mar 17;10(3):e0120640. doi: 10.1371/journal.pone.0120640. eCollection 2015.

Reference Type BACKGROUND
PMID: 25781012 (View on PubMed)

Vekony T, Nemeth VL, Holczer A, Kocsis K, Kincses ZT, Vecsei L, Must A. Continuous theta-burst stimulation over the dorsolateral prefrontal cortex inhibits improvement on a working memory task. Sci Rep. 2018 Oct 4;8(1):14835. doi: 10.1038/s41598-018-33187-3.

Reference Type BACKGROUND
PMID: 30287868 (View on PubMed)

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, Noel 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-Garcia 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.

Reference Type BACKGROUND
PMID: 31271802 (View on PubMed)

McNeill A, Monk RL, Qureshi AW, Makris S, Heim D. Continuous Theta Burst Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex Impairs Inhibitory Control and Increases Alcohol Consumption. Cogn Affect Behav Neurosci. 2018 Dec;18(6):1198-1206. doi: 10.3758/s13415-018-0631-3.

Reference Type BACKGROUND
PMID: 30132267 (View on PubMed)

Boggio PS, Ferrucci R, Rigonatti SP, Covre P, Nitsche M, Pascual-Leone A, Fregni F. Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. J Neurol Sci. 2006 Nov 1;249(1):31-8. doi: 10.1016/j.jns.2006.05.062. Epub 2006 Jul 14.

Reference Type BACKGROUND
PMID: 16843494 (View on PubMed)

Short BE, Borckardt JJ, Anderson BS, Frohman H, Beam W, Reeves ST, George MS. Ten sessions of adjunctive left prefrontal rTMS significantly reduces fibromyalgia pain: a randomized, controlled pilot study. Pain. 2011 Nov;152(11):2477-2484. doi: 10.1016/j.pain.2011.05.033. Epub 2011 Jul 20.

Reference Type BACKGROUND
PMID: 21764215 (View on PubMed)

To WT, De Ridder D, Hart J Jr, Vanneste S. Changing Brain Networks Through Non-invasive Neuromodulation. Front Hum Neurosci. 2018 Apr 13;12:128. doi: 10.3389/fnhum.2018.00128. eCollection 2018.

Reference Type BACKGROUND
PMID: 29706876 (View on PubMed)

Zilverstand A, Huang AS, Alia-Klein N, Goldstein RZ. Neuroimaging Impaired Response Inhibition and Salience Attribution in Human Drug Addiction: A Systematic Review. Neuron. 2018 Jun 6;98(5):886-903. doi: 10.1016/j.neuron.2018.03.048.

Reference Type BACKGROUND
PMID: 29879391 (View on PubMed)

Sheng J, Liu S, Wang Y, Cui R, Zhang X. The Link between Depression and Chronic Pain: Neural Mechanisms in the Brain. Neural Plast. 2017;2017:9724371. doi: 10.1155/2017/9724371. Epub 2017 Jun 19.

Reference Type BACKGROUND
PMID: 28706741 (View on PubMed)

Moran TP, Jendrusina AA, Moser JS. The psychometric properties of the late positive potential during emotion processing and regulation. Brain Res. 2013 Jun 21;1516:66-75. doi: 10.1016/j.brainres.2013.04.018. Epub 2013 Apr 17.

Reference Type BACKGROUND
PMID: 23603408 (View on PubMed)

Other Identifiers

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NEUR-2020-29420

Identifier Type: -

Identifier Source: org_study_id

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