Parkinson DiseaseAttParkNCT05073874
Attentional Focus and Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease (PD)
A study testing Functional Near-Infrared Spectroscopy (fNIRS) in people with Parkinson Disease, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
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. Thirty older adults and thirty PD will participate in this study. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Functional Near-Infrared Spectroscopy (fNIRS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2021to 8 May 2024
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Group Parkinson:
- freezing
- Hoehn et Yahr > III
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Functional Near-Infrared Spectroscopy (fNIRS)
- Keywords
- Attention, NIRS, Gait, Prefrontal cortex, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Near-Infrared Spectroscopy (fNIRS)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Functional Near-Infrared Spectroscopy (fNIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Effects of deoxyhemoglobin variations on hemodynamic response in prefrontal cortex
Deoxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system
Measured: Baseline
Secondary outcomes (4)
Effects of speed on gait.
Gait parameters will be measured with connected soles FeetMe ® : speed
Measured: baseline
Effects of cadence on gait.
Gait parameters will be measured with connected soles FeetMe ® : cadence
Measured: baseline
Effects of stride length on gait.
Gait parameters will be measured with connected soles FeetMe ® : stride length
Measured: baseline
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.
- First posted12 Oct 2021
- Study start8 Dec 2021
- Primary completion2 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Canan OZSANCAK, Dr, Principal investigator, CHR d'ORLEANS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05073874
- Sponsor's protocol ID
- CHRO-2021-06
- Acronym
- AttPark
- Status last verified
- Aug 2024
- First submitted
- 29 Sep 2021
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 17004944Hausdorff 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.
PubMed 17618701Mahoney 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.
PubMed 26551767Plotnik 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.
PubMed 21279632Yogev-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 20023000Pelicioni 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 31110922Wulf 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 20037032Holtzer 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.
PubMed 26613725Maidan 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.
PubMed 28439757Yogev-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 18058946Lu 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 26079605Udina 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 32038224Kal 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 24054892Nieuwhof 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.
PubMed 27965875Yogev-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.
PubMed 27715480
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05073874
- Acronym / sponsor ID
- AttPark / CHRO-2021-06
- Conditions
- Parkinson Disease
- Keywords
- Attention, NIRS, Gait, Prefrontal cortex, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 2 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Near-Infrared Spectroscopy (fNIRS) | Other | Other: Functional Near-Infrared Spectroscopy (fNIRS)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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- For 2 groups :
- Group Parkinson : clinical diagnosis of idiopathic Parkinson's Disease, according to the UK Brain Bank criteria.
Key exclusion criteria (9 listed)
- For 2 groups :
- Group Parkinson:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Near-Infrared Spectroscopy (fNIRS)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. | Other | Functional Near-Infrared Spectroscopy (fNIRS) |
Primary outcome
Effects of oxyhemoglobin variations on hemodynamic response in prefrontal cortex
Time frame: Baseline
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
Time frame: Baseline
Deoxyhemoglobin variations in prefrontal cortex will be measured with a fNIRS system
4 secondary outcomes
Effects of speed on gait.
Time frame: baseline
Effects of cadence on gait.
Time frame: baseline
Effects of stride length on gait.
Time frame: baseline
Effects of double support time on gait.
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 17004944Baltadjieva 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.
- Background: PubMed 17618701Hausdorff 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.
- Background: PubMed 26551767Mahoney 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.
- Background: PubMed 21279632Plotnik 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.
- Background: PubMed 20023000Yogev-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.
- Background: PubMed 31110922Pelicioni 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.
- Background: PubMed 20037032Wulf 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.
- Background: PubMed 26613725Holtzer 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.
- Background: PubMed 28439757Maidan 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.
- Background: PubMed 18058946Yogev-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.
- Background: PubMed 26079605Lu 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.
- Background: PubMed 32038224Udina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Canan OZSANCAK, Dr principal investigator
CHR d'ORLEANS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Near-Infrared Spectroscopy (fNIRS) in people with Parkinson Disease, 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 9 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 2 Aug 2024. 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 oxyhemoglobin variations 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 NCT05073874, which also lists 17 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 2 Aug 2024.