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HealthyAttNIRSNCT04757844

Attentional Focus and Prefrontal Cortical Activation

A study testing Functional Near-Infrared Spectroscopy (fNIRS) in people with Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Functional Near-Infrared Spectroscopy (fNIRS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteFrance
Study dates
12 Feb 2021to 19 Apr 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHR Orléans

    Orléans, 45067

Other trials in France

About this study

Official title: The Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Young Healthy Adults

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.

Conditions
Healthy
Being tested
Functional Near-Infrared Spectroscopy (fNIRS)
Keywords
near infrared spectroscopy, prefrontal cortex, attention, gait

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Functional Near-Infrared Spectroscopy (fNIRS)Device

    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.

Study groups in NCT04757844
Study groupRoleWhat they receive
Young healthy voluntary adultsExperimental30 young healthy voluntary adults
Receives: Device: Functional Near-Infrared Spectroscopy (fNIRS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Oxyhemoglobin variations in prefrontal cortex measured with fNIRS

    Measured: Baseline

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

    Deoxyhemoglobin variations in prefrontal cortex measured with fNIRS

    Measured: Baseline

Secondary outcomes (4)

  1. Effects of speed on gait.

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

    Measured: Baseline

  2. Effects of cadence on gait.

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

    Measured: Baseline

  3. Effects of stride length on gait.

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

    Measured: Baseline

  4. Effects of double support time on gait.

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2021
  2. Study start12 Feb 2021
  3. Primary completion19 Apr 2021
  4. Study completion19 Apr 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04757844
Sponsor's protocol ID
CHRO 2020-22
Acronym
AttNIRS
Status last verified
Aug 2021
First submitted
9 Feb 2021
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Functional Near-Infrared Spectroscopy (fNIRS) in people with Healthy, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effects of different attentional conditions on hemodynamic response in prefrontal cortex (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04757844, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.

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