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NCT Number: NCT05073874

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Orléans

Orléans, 45067, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Effects of speed on gait.

    Time frame: baseline

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

  2. Effects of cadence on gait.

    Time frame: baseline

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

  3. Effects of stride length on gait.

    Time frame: baseline

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

  4. Effects of double support time on gait.

    Time frame: baseline

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Registry information

Official study title

Effects of Different Attentional Focus During Walking on Prefrontal Cortical Activation in Older Adults and Patients With Parkinson's Disease

Acronym: AttPark

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 12, 2021
Registry last updated
Aug 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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