search
Back to results

Attentional Focus and Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease (PD) (AttPark)

Primary Purpose

Parkinson Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Near-Infrared Spectroscopy (fNIRS)
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson Disease focused on measuring Attention, NIRS, Gait, Prefrontal cortex, Parkinson's disease

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • CHR OrléansRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Functional Near-Infrared Spectroscopy (fNIRS)

Arm Description

Subjects will be guided to walk at a normal pace while maintaining the required attentional focus: no instructions about the attentional focus internal focus on their feet movements, external focus on two lines drawn on the floor, 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.

Outcomes

Primary Outcome Measures

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.
Effects of deoxyhemoglobin variations on hemodynamic response in prefrontal cortex
Deoxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system

Secondary Outcome Measures

Effects of speed on gait.
Gait parameters will be measured with connected soles FeetMe ® : speed
Effects of cadence on gait.
Gait parameters will be measured with connected soles FeetMe ® : cadence
Effects of stride length on gait.
Gait parameters will be measured with connected soles FeetMe ® : stride length
Effects of double support time on gait.
Gait parameters will be measured with connected soles FeetMe ® : double support time.

Full Information

First Posted
September 29, 2021
Last Updated
September 18, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
search

1. Study Identification

Unique Protocol Identification Number
NCT05073874
Brief Title
Attentional Focus and Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease (PD)
Acronym
AttPark
Official Title
Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
June 8, 2024 (Anticipated)
Study Completion Date
June 8, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
The subjects will be guided to walk at a normal pace while maintaining the required attentional focus. Subjects will walk on 20 m four times in each of the four different focus conditions : no instructions about the attentional focus internal focus on their feet movements, external focus on two lines drawn on the floor, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Attention, NIRS, Gait, Prefrontal cortex, Parkinson's disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional Near-Infrared Spectroscopy (fNIRS)
Arm Type
Other
Arm Description
Subjects will be guided to walk at a normal pace while maintaining the required attentional focus: no instructions about the attentional focus internal focus on their feet movements, external focus on two lines drawn on the floor, 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.
Intervention Type
Other
Intervention Name(s)
Functional Near-Infrared Spectroscopy (fNIRS)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effects of oxyhemoglobin variations on hemodynamic response in prefrontal cortex
Description
Oxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system, on a 20 meters distance.
Time Frame
Baseline
Title
Effects of deoxyhemoglobin variations on hemodynamic response in prefrontal cortex
Description
Deoxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Effects of speed on gait.
Description
Gait parameters will be measured with connected soles FeetMe ® : speed
Time Frame
baseline
Title
Effects of cadence on gait.
Description
Gait parameters will be measured with connected soles FeetMe ® : cadence
Time Frame
baseline
Title
Effects of stride length on gait.
Description
Gait parameters will be measured with connected soles FeetMe ® : stride length
Time Frame
baseline
Title
Effects of double support time on gait.
Description
Gait parameters will be measured with connected soles FeetMe ® : double support time.
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie DESPUJOLS
Phone
+33238744071
Email
aurelie.despujols@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Canan OZSANCAK, Dr
Organizational Affiliation
CHR d'ORLEANS
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canan OZSANCAK, DR
Phone
+33 2 38 22 99 47
Email
canan.ozsan@chr-orleans.fr
First Name & Middle Initial & Last Name & Degree
Canan OZSANCAK, Dr

12. IPD Sharing Statement

Citations:
PubMed Identifier
17004944
Citation
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.
Results Reference
background
PubMed Identifier
17618701
Citation
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.
Results Reference
background
PubMed Identifier
26551767
Citation
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.
Results Reference
background
PubMed Identifier
21279632
Citation
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.
Results Reference
background
PubMed Identifier
20023000
Citation
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.
Results Reference
background
PubMed Identifier
31110922
Citation
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.
Results Reference
background
PubMed Identifier
20037032
Citation
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.
Results Reference
background
PubMed Identifier
26613725
Citation
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.
Results Reference
background
PubMed Identifier
28439757
Citation
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.
Results Reference
background
PubMed Identifier
18058946
Citation
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.
Results Reference
background
PubMed Identifier
26079605
Citation
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.
Results Reference
background
PubMed Identifier
32038224
Citation
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.
Results Reference
background
PubMed Identifier
24054892
Citation
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.
Results Reference
background
PubMed Identifier
27965875
Citation
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.
Results Reference
background
PubMed Identifier
27715480
Citation
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.
Results Reference
background
PubMed Identifier
21593013
Citation
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.
Results Reference
background
PubMed Identifier
32654627
Citation
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.
Results Reference
background

Learn more about this trial

Attentional Focus and Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease (PD)

We'll reach out to this number within 24 hrs