NCT05073874

Brief 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 older adults and thirty PD will participate in this study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 8, 2021

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2024

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
Last Updated

August 2, 2024

Status Verified

August 1, 2024

Enrollment Period

2.4 years

First QC Date

September 29, 2021

Last Update Submit

August 1, 2024

Conditions

Keywords

AttentionNIRSGaitPrefrontal cortexParkinson's disease

Outcome Measures

Primary Outcomes (2)

  • Effects of oxyhemoglobin variations on hemodynamic response in prefrontal cortex

    Oxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system, on a 20 meters distance.

    Baseline

  • Effects of deoxyhemoglobin variations on hemodynamic response in prefrontal cortex

    Deoxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system

    Baseline

Secondary Outcomes (4)

  • Effects of speed on gait.

    baseline

  • Effects of cadence on gait.

    baseline

  • Effects of stride length on gait.

    baseline

  • Effects of double support time on gait.

    baseline

Study Arms (1)

Functional Near-Infrared Spectroscopy (fNIRS)

OTHER

Subjects will be guided to walk at a normal pace while maintaining the required attentional focus: 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 connected soles for gait analyses.

Other: Functional Near-Infrared Spectroscopy (fNIRS)

Interventions

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

Functional Near-Infrared Spectroscopy (fNIRS)

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For 2 groups :
  • Man or woman 60-85 years old
  • Informed consent obtained
  • Group Parkinson : clinical diagnosis of idiopathic Parkinson's Disease, according to the UK Brain Bank criteria.

You may not qualify if:

  • For 2 groups :
  • Assisted walker
  • Neurological (other than those resulting from Parkinson's disease), cardiologic, rheumatologic disorders
  • Disorders affecting gait.
  • Montreal Cognitive Assessment (MOCA) \< 24.
  • Concomitant medication likely to interfere with the results.
  • Group Parkinson:
  • freezing
  • Hoehn et Yahr \> III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Orléans

Orléans, 45067, France

Location

Related Publications (17)

  • Baltadjieva R, Giladi N, Gruendlinger L, Peretz C, Hausdorff JM. Marked alterations in the gait timing and rhythmicity of patients with de novo Parkinson's disease. Eur J Neurosci. 2006 Sep;24(6):1815-20. doi: 10.1111/j.1460-9568.2006.05033.x.

    PMID: 17004944BACKGROUND
  • Hausdorff JM. Gait dynamics, fractals and falls: finding meaning in the stride-to-stride fluctuations of human walking. Hum Mov Sci. 2007 Aug;26(4):555-89. doi: 10.1016/j.humov.2007.05.003. Epub 2007 Jul 5.

    PMID: 17618701BACKGROUND
  • Mahoney JR, Holtzer R, Izzetoglu M, Zemon V, Verghese J, Allali G. The role of prefrontal cortex during postural control in Parkinsonian syndromes a functional near-infrared spectroscopy study. Brain Res. 2016 Feb 15;1633:126-138. doi: 10.1016/j.brainres.2015.10.053. Epub 2015 Nov 6.

    PMID: 26551767BACKGROUND
  • Plotnik M, Giladi N, Dagan Y, Hausdorff JM. Postural instability and fall risk in Parkinson's disease: impaired dual tasking, pacing, and bilateral coordination of gait during the "ON" medication state. Exp Brain Res. 2011 May;210(3-4):529-38. doi: 10.1007/s00221-011-2551-0. Epub 2011 Jan 30.

    PMID: 21279632BACKGROUND
  • 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.

    PMID: 20023000BACKGROUND
  • 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.

    PMID: 31110922BACKGROUND
  • 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.

    PMID: 20037032BACKGROUND
  • Holtzer R, Verghese J, Allali G, Izzetoglu M, Wang C, Mahoney JR. Neurological Gait Abnormalities Moderate the Functional Brain Signature of the Posture First Hypothesis. Brain Topogr. 2016 Mar;29(2):334-43. doi: 10.1007/s10548-015-0465-z. Epub 2015 Nov 27.

    PMID: 26613725BACKGROUND
  • Maidan I, Bernad-Elazari H, Giladi N, Hausdorff JM, Mirelman A. When is Higher Level Cognitive Control Needed for Locomotor Tasks Among Patients with Parkinson's Disease? Brain Topogr. 2017 Jul;30(4):531-538. doi: 10.1007/s10548-017-0564-0. Epub 2017 Apr 24.

    PMID: 28439757BACKGROUND
  • 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.

    PMID: 18058946BACKGROUND
  • 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.

    PMID: 26079605BACKGROUND
  • 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.

    PMID: 32038224BACKGROUND
  • 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.

    PMID: 24054892BACKGROUND
  • Nieuwhof F, Reelick MF, Maidan I, Mirelman A, Hausdorff JM, Olde Rikkert MG, Bloem BR, Muthalib M, Claassen JA. Measuring prefrontal cortical activity during dual task walking in patients with Parkinson's disease: feasibility of using a new portable fNIRS device. Pilot Feasibility Stud. 2016 Sep 23;2:59. doi: 10.1186/s40814-016-0099-2. eCollection 2016.

    PMID: 27965875BACKGROUND
  • Yogev-Seligmann G, Sprecher E, Kodesh E. The Effect of External and Internal Focus of Attention on Gait Variability in Older Adults. J Mot Behav. 2017 Mar-Apr;49(2):179-184. doi: 10.1080/00222895.2016.1169983. Epub 2016 Aug 11.

    PMID: 27715480BACKGROUND
  • 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.

    PMID: 21593013BACKGROUND
  • 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.

    PMID: 32654627BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Canan OZSANCAK, Dr

    CHR d'ORLEANS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

December 8, 2021

Primary Completion

May 2, 2024

Study Completion

May 8, 2024

Last Updated

August 2, 2024

Record last verified: 2024-08

Locations