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CompletedNCT04757844AttNIRSUpdated Sep 1, 2021

Attentional Focus and Prefrontal Cortical Activation

An interventional study of Functional Near-Infrared Spectroscopy (fNIRS) in Healthy, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 1 site in France. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-09-01.

Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 30 Years
Sex
All
01

Study summary

Attention may influence the motor performance and frontal activity. This study will examine the effect of different attentional focus : internal, external and divided attention (dual task) on prefrontal cortical activation (fNIRS) and on gait performance. Thirty young healthy voluntary adults will participate in this study.

Read the detailed description

The subjects will be guided to walk at a normal pace while maintaining the required attentional focus. They will walk on 30 m five times in each of the four different focus conditions :1) no instructions about the attentional focus 2) internal focus on their feet movements, 3) external focus on two lines drawn on the floor, 4) divided attention (walking while performing an arithmetic task). A fNIRS system will be used for the prefrontal cortex activation evaluation and FeetMe soles for gait analyses.

02

Conditions studied

  • Healthy

Keywords

  • near infrared spectroscopy
  • prefrontal cortex
  • attention
  • gait
03

In context

Lead sponsor

Centre Hospitalier Régional d'Orléans is the lead sponsor of 129 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 30 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Man or woman
  • 18 -30 years old
  • Informed consent obtained
  • Free from any neurological, cardiologic, rheumatologic disorders.

Exclusion criteria

Exclusion Criteria:

  • Assisted walker.
  • Disorders affecting gait.
  • Concomitant medication likely to interfere with the results.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Young healthy voluntary adults

    30 young healthy voluntary adults

    Device: Functional Near-Infrared Spectroscopy (fNIRS)

Interventions

  • DeviceFunctional Near-Infrared Spectroscopy (fNIRS)

    The hemodynamic response in prefrontal cortex will be measured using an Octamon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.

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What researchers measure

Primary outcomes

  1. Effects of different attentional conditions on hemodynamic response in prefrontal cortex

    Oxyhemoglobin variations in prefrontal cortex measured with fNIRS

    Time frame: Baseline

  2. Effects of different attentional conditions on hemodynamic response in prefrontal cortex

    Deoxyhemoglobin variations in prefrontal cortex measured with fNIRS

    Time frame: Baseline

Secondary outcomes

  1. Effects of speed on gait.

    Gait parameters will be measured with connected soles FeetMe ® : speed

    Time frame: Baseline

  2. Effects of cadence on gait.

    Gait parameters will be measured with connected soles FeetMe ® : cadence

    Time frame: Baseline

  3. Effects of stride length on gait.

    Gait parameters will be measured with connected soles FeetMe ® : stride length

    Time frame: Baseline

  4. Effects of double support time on gait.

    Gait parameters will be measured with connected soles FeetMe ® : double support time

    Time frame: Baseline

07

Study locations

1 site
  • CHR Orléans
    Orléans, 45067, France
08

References and documents

Publications

  • Wulf G, Hoss M, Prinz W. Instructions for motor learning: differential effects of internal versus external focus of attention. J Mot Behav. 1998 Jun;30(2):169-79. doi: 10.1080/00222899809601334. PubMed 20037032 ↗
  • Kim SA, Ryu YU, Shin HK. The effects of different attentional focus on poststroke gait. J Exerc Rehabil. 2019 Aug 28;15(4):592-596. doi: 10.12965/jer.1938360.180. eCollection 2019 Aug. PubMed 31523682 ↗
  • Lu CF, Liu YC, Yang YR, Wu YT, Wang RY. Maintaining Gait Performance by Cortical Activation during Dual-Task Interference: A Functional Near-Infrared Spectroscopy Study. PLoS One. 2015 Jun 16;10(6):e0129390. doi: 10.1371/journal.pone.0129390. eCollection 2015. PubMed 26079605 ↗
  • Herold F, Wiegel P, Scholkmann F, Thiers A, Hamacher D, Schega L. Functional near-infrared spectroscopy in movement science: a systematic review on cortical activity in postural and walking tasks. Neurophotonics. 2017 Oct;4(4):041403. doi: 10.1117/1.NPh.4.4.041403. Epub 2017 Aug 1. PubMed 28924563 ↗
  • Farid L, Jacobs D, Do Santos J, Simon O, Gracies JM, Hutin E. FeetMe(R) Monitor-connected insoles are a valid and reliable alternative for the evaluation of gait speed after stroke. Top Stroke Rehabil. 2021 Mar;28(2):127-134. doi: 10.1080/10749357.2020.1792717. Epub 2020 Jul 13. PubMed 32654627 ↗
  • Kal EC, van der Kamp J, Houdijk H. External attentional focus enhances movement automatization: a comprehensive test of the constrained action hypothesis. Hum Mov Sci. 2013 Aug;32(4):527-39. doi: 10.1016/j.humov.2013.04.001. Epub 2013 Jun 30. PubMed 24054892 ↗
  • Yogev-Seligmann G, Hausdorff JM, Giladi N. The role of executive function and attention in gait. Mov Disord. 2008 Feb 15;23(3):329-42; quiz 472. doi: 10.1002/mds.21720. PubMed 18058946 ↗
  • Wood JN, Grafman J. Human prefrontal cortex: processing and representational perspectives. Nat Rev Neurosci. 2003 Feb;4(2):139-47. doi: 10.1038/nrn1033. No abstract available. PubMed 12563285 ↗
  • Pelicioni PHS, Tijsma M, Lord SR, Menant J. Prefrontal cortical activation measured by fNIRS during walking: effects of age, disease and secondary task. PeerJ. 2019 May 3;7:e6833. doi: 10.7717/peerj.6833. eCollection 2019. PubMed 31110922 ↗
  • Shafizadeh M, Platt GK, Mohammadi B. Effects of different focus of attention rehabilitative training on gait performance in Multiple Sclerosis patients. J Bodyw Mov Ther. 2013 Jan;17(1):28-34. doi: 10.1016/j.jbmt.2012.04.005. Epub 2012 May 10. PubMed 23294680 ↗
  • Yogev-Seligmann G, Rotem-Galili Y, Mirelman A, Dickstein R, Giladi N, Hausdorff JM. How does explicit prioritization alter walking during dual-task performance? Effects of age and sex on gait speed and variability. Phys Ther. 2010 Feb;90(2):177-86. doi: 10.2522/ptj.20090043. Epub 2009 Dec 18. PubMed 20023000 ↗
  • Holtzer R, Mahoney JR, Izzetoglu M, Izzetoglu K, Onaral B, Verghese J. fNIRS study of walking and walking while talking in young and old individuals. J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):879-87. doi: 10.1093/gerona/glr068. Epub 2011 May 17. PubMed 21593013 ↗
  • Udina C, Avtzi S, Durduran T, Holtzer R, Rosso AL, Castellano-Tejedor C, Perez LM, Soto-Bagaria L, Inzitari M. Functional Near-Infrared Spectroscopy to Study Cerebral Hemodynamics in Older Adults During Cognitive and Motor Tasks: A Review. Front Aging Neurosci. 2020 Jan 21;11:367. doi: 10.3389/fnagi.2019.00367. eCollection 2019. PubMed 32038224 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04757844
Lead sponsor
Centre Hospitalier Régional d'Orléans
Responsible party
Sponsor
First posted
Feb 17, 2021
Start date
Feb 12, 2021
Primary completion
Apr 19, 2021
Completion
Apr 19, 2021
Last update
Sep 1, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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