NCT05789121

Brief Summary

The purpose of this study is to investigate the cerebral activation in healthy subjects in 4 conditions of gait :

  • Gait at preferred cadence without auditory stimulation (Gait1)
  • Gait with low tempo rhythmic auditory stimulation by music (RAS-Slow). The beat rate of the music was 68.5 per minute for all participants.
  • Gait with fast tempo synchronous rhythmic auditory stimulation by music (RAS-Fast). The beat rate of the music was set to 10% above each patient's preferred gait cadence . The preferred cadence was considered as the mean of the 6 trials during Gait 1.
  • Gait without auditory stimulation (Gait2) The investigators goal is to compare cerebral activation and gait parameters during the 4 different tasks using fNIRS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

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

March 10, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
Last Updated

March 31, 2023

Status Verified

March 1, 2023

Enrollment Period

10 days

First QC Date

March 10, 2023

Last Update Submit

March 29, 2023

Conditions

Keywords

Rhythmic auditory stimulationGaitNear infrared spectroscopy

Outcome Measures

Primary Outcomes (2)

  • Mean change in the concentration of oxyhemoglobin during the task

    Day 0

  • Mean change in the concentration of deoxyhemoglobin during the task

    Day 0

Secondary Outcomes (4)

  • Walking speed

    Day 0

  • Number of steps within a minute walk (in steps/min)

    Day 0

  • stride length

    Day 0

  • double support time

    Day 0

Study Arms (1)

Healthy subjects

30 healthy subject aged between 18 and 40.

Device: walking 25 m in 4 different conditions

Interventions

The protocol consisted of walking 25 m in 4 different conditions in the following order: Gait1, RAS-Slow, RAS-fast, Gait2. * Gait 1 : preferred cadence without auditory stimulation * RAS-Slow : Gait with low tempo rhythmic auditory stimulation by music (68.5 per minute). * RAS-Fast : Gait with fast tempo (10% above each Gait1 cadence). * Gait2 : preferred cadence without auditory stimulation

Healthy subjects

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects aged between 18 and 40 years

You may qualify if:

  • Age 18 to 40 years old.
  • No known neurological disease
  • Benefiting from a social security coverage.
  • Sufficient knowledge of the French language to understand the instructions

You may not qualify if:

  • Person under tutorship or curatorship
  • Known allergy to components of the fNIRS device: neoprene
  • History of neurological disease
  • History of rheumatological disease affecting walking
  • Pregnant or breastfeeding women
  • Subjects opposed to participating in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR Orléans

Orléans, 45067, France

Location

Related Publications (7)

  • Altenmuller E, Schlaug G. Apollo's gift: new aspects of neurologic music therapy. Prog Brain Res. 2015;217:237-52. doi: 10.1016/bs.pbr.2014.11.029. Epub 2015 Feb 11.

    PMID: 25725918BACKGROUND
  • Bonnal J, Monnet F, Le BT, Pila O, Grosmaire AG, Ozsancak C, Duret C, Auzou P. Relation between Cortical Activation and Effort during Robot-Mediated Walking in Healthy People: A Functional Near-Infrared Spectroscopy Neuroimaging Study (fNIRS). Sensors (Basel). 2022 Jul 25;22(15):5542. doi: 10.3390/s22155542.

    PMID: 35898041BACKGROUND
  • Braunlich K, Seger CA, Jentink KG, Buard I, Kluger BM, Thaut MH. Rhythmic auditory cues shape neural network recruitment in Parkinson's disease during repetitive motor behavior. Eur J Neurosci. 2019 Mar;49(6):849-858. doi: 10.1111/ejn.14227. Epub 2018 Dec 3.

    PMID: 30375083BACKGROUND
  • 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
  • Koshimori Y, Thaut MH. Future perspectives on neural mechanisms underlying rhythm and music based neurorehabilitation in Parkinson's disease. Ageing Res Rev. 2018 Nov;47:133-139. doi: 10.1016/j.arr.2018.07.001. Epub 2018 Jul 10.

    PMID: 30005957BACKGROUND
  • Merchant H, Grahn J, Trainor L, Rohrmeier M, Fitch WT. Finding the beat: a neural perspective across humans and non-human primates. Philos Trans R Soc Lond B Biol Sci. 2015 Mar 19;370(1664):20140093. doi: 10.1098/rstb.2014.0093.

    PMID: 25646516BACKGROUND
  • Thaut MH. The discovery of human auditory-motor entrainment and its role in the development of neurologic music therapy. Prog Brain Res. 2015;217:253-66. doi: 10.1016/bs.pbr.2014.11.030. Epub 2015 Feb 2.

    PMID: 25725919BACKGROUND

Study Officials

  • Auzou PASCAL, Dr

    CHR d'Orleans

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2023

First Posted

March 29, 2023

Study Start

March 14, 2023

Primary Completion

March 24, 2023

Study Completion

March 24, 2023

Last Updated

March 31, 2023

Record last verified: 2023-03

Locations