NCT04864080

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
10mo left

Started Apr 2022

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Apr 2022Mar 2027

First Submitted

Initial submission to the registry

January 20, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
12 months until next milestone

Study Start

First participant enrolled

April 11, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

January 20, 2021

Last Update Submit

March 2, 2026

Conditions

PainDepression

Outcome Measures

Primary Outcomes (1)

  • 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.

    1-7 days

Secondary Outcomes (1)

  • Acceptability

    1-7 days

Study Arms (2)

Healthy Comparison Group

ACTIVE COMPARATOR

Behavioral tasks and surveys online.

Behavioral: Computer game/taskBehavioral: Health surveys online

Pain/Depression patients from clinic

EXPERIMENTAL

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

Behavioral: Computer game/taskBehavioral: Health surveys online

Interventions

Computer game/taskBEHAVIORAL

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

Also known as: Behavioral tasks online and in-person.
Healthy Comparison GroupPain/Depression patients from clinic
Health surveys onlineBEHAVIORAL

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

Also known as: PHQ-9, MASQ, GAD-7
Healthy Comparison GroupPain/Depression patients from clinic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have access to the online study platform.

You may not qualify if:

  • under 18, non-English speaking
  • Arm 2: pain and depression:
  • Pain or depression
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (12)

  • 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.

    PMID: 15664172BACKGROUND

  • 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.

    PMID: 29352668BACKGROUND

  • 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.

    PMID: 25781012BACKGROUND

  • 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.

    PMID: 30287868BACKGROUND

  • 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.

    PMID: 31271802BACKGROUND

  • 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.

    PMID: 30132267BACKGROUND

  • 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.

    PMID: 16843494BACKGROUND

  • 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.

    PMID: 21764215BACKGROUND

  • 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.

    PMID: 29706876BACKGROUND

  • 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.

    PMID: 29879391BACKGROUND

  • 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.

    PMID: 28706741BACKGROUND

  • 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.

    PMID: 23603408BACKGROUND

MeSH Terms

Conditions

PainDepression

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesPsychological TestsBehavioral Disciplines and ActivitiesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

David Darrow

CONTACT

(612) 624-6666hdlab@umn.edu

MATTHEW D Maple

CONTACT

612-946-1424maple036@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Feasibility study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2021

First Posted

April 28, 2021

Study Start

April 11, 2022

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

US(1)