Reproducibility of fNIRS Parameters During Walking

NCT04882930 | Completed

• 1 other identifier: CHRO-2020-23
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 3

Brief Summary

Brain activation can be studied using the Functional Near InfraRed Spectroscopy (fNIRS). It was shown that CPF activation during walking and during dual task could be different in stroke patients and in healthy subjects. To date, fNIRS reliability is not completely established during walking and during dual task. Therefore, this study will examine the reproducibility of fNIRS parameters during simple walking and during dual task in healthy subjects and in stroke patients.

Conditions

Stroke

Keywords

fNIRS; reproductibility; stroke; gait

Outcome Measures

Primary Outcomes (2)

• Oxyhemoglobin (HbO) variations during simple walking and during dual task

  HbO will be measured by the NIR spectrometry technique continuously at rest and during walking. This technique allows to measure the variations of HbO concentration by measuring the variations of light absorption by the explored tissues.

  Day 0

• Deoxyhemoglobin (HbR) variations during simple walking and during dual task

  HbR will be measured by the NIR spectrometry technique continuously at rest and during walking. This technique allows to measure the variations of HbR concentration by measuring the variations of light absorption by the explored tissues.

  Day 0

Secondary Outcomes (6)

• Oxyhemoglobin (HbO) variations of acute stroke patients

  Day 0

• Deoxyhemoglobin (HbR) variations of acute stroke patients

  Day 0

• Oxyhemoglobin (HbO) variations of subacute stroke patients

  Day 0

• Deoxyhemoglobin (HbR) variations of subacute stroke patients

  Day 0

• Oxyhemoglobin (HbO) variations using different mathematical treatments.

  Day 0

Study Arms (1)

Functional Near-Infrared Spectroscopy (fNIRS) acquisitions

EXPERIMENTAL

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

Procedure: Functional Near-Infrared Spectroscopy (fNIRS)

Interventions

Functional Near-Infrared Spectroscopy (fNIRS) PROCEDURE

All participants will undergo Functional Near-Infrared Spectroscopy (fNIRS). The hemodynamic response in CPF 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) acquisitions

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acute stroke group, subacute stroke group, and control group:
• Age 50 to 80 years
• Affiliated with a social security plan
• Able to walk 20 meters unassisted
• Acute Stroke and Subacute Stroke Group:
• Stroke onset less than 14 days (for the acute stroke group) or between 14 days and 6 months (for the subacute stroke group)
• Stroke located in the left or right middle cerebral artery.

You may not qualify if:

• Acute stroke group, subacute stroke group, and control group:
• Person under guardianship or curatorship
• Refusal to sign informed consent
• Known rheumatologic or cardiologic history
• Medication that alters the vigilance and may affect walking (high dose psychotropic drugs, antispastic drugs).
• Acute stroke group and subacute stroke group:
• History of symptomatic stroke
• Previous neurological disease limiting gait, aphasia or impaired cognitive function (mild cognitive dementia, Alzheimer's or Parkinson's disease)
• Ambulatory functional category \< 3
• Control group: neurological medical history

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead

Study Sites (3)

Centre de Réadaptation Fonctionnelle et d'Appareillage Le Coteau

La Chapelle-Saint-Mesmin, France

Location

Chu Limoges

Limoges, France

Location

CHR Orléans

Orléans, 45067, France

Location

Related Publications (4)

• Hermand E, Tapie B, Dupuy O, Fraser S, Compagnat M, Salle JY, Daviet JC, Perrochon A. Prefrontal Cortex Activation During Dual Task With Increasing Cognitive Load in Subacute Stroke Patients: A Pilot Study. Front Aging Neurosci. 2019 Jul 2;11:160. doi: 10.3389/fnagi.2019.00160. eCollection 2019.

  PMID: 31312136 BACKGROUND

• Hawkins KA, Fox EJ, Daly JJ, Rose DK, Christou EA, McGuirk TE, Otzel DM, Butera KA, Chatterjee SA, Clark DJ. Prefrontal over-activation during walking in people with mobility deficits: Interpretation and functional implications. Hum Mov Sci. 2018 Jun;59:46-55. doi: 10.1016/j.humov.2018.03.010. Epub 2018 Mar 29.

  PMID: 29604488 BACKGROUND

• Holden MK, Gill KM, Magliozzi MR, Nathan J, Piehl-Baker L. Clinical gait assessment in the neurologically impaired. Reliability and meaningfulness. Phys Ther. 1984 Jan;64(1):35-40. doi: 10.1093/ptj/64.1.35.

  PMID: 6691052 BACKGROUND

• 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: 31110922 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Andreea AIGNATOAIE

  CHR d'Orléans

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Healthy subjects, acute stroke patients, subacute stroke patients

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 12, 2021
• Study Start: June 29, 2021
• Primary Completion: September 8, 2023
• Study Completion: September 8, 2023
• Last Updated: August 2, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)