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Recruiting NCT04864080

Transdiagnostic Cognitive Biomarkers

No phase Interventional Pain Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Computer game/task, Health surveys online.
Who it may be relevant to
Registry conditions: Pain, Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Computer game/task
    N-back, COGED, PacMan game, Bandit task, Websurf task.
  • Behavioral Health surveys online
    Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.

Primary outcome measures

  • Feasibility for all aspects of the study [Time frame: 1-7 days]
Secondary outcome measures (1)
  • Acceptability [Time frame: 1-7 days]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Publications

  • 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 15664172
  • 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 29352668
  • 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 25781012
  • 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 30287868
  • 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, Montem PMID 31271802
  • 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 30132267
  • 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 16843494
  • 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 21764215

Identifiers

NCT: NCT04864080 · NEUR-2020-29420

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗