Trial document




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  DRKS00015190

Trial Description

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Title

Functional near-infrared spectroscopy in multiple sclerosis: gait automaticity with and without fatigability

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Trial Acronym

fNIRS-MS

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

Background:
Gait is a highly automatized process that is often limited in people suffering from neurodegenerative diseases such as Multiple Sclerosis (MS). So far, there are plenty of studies about the change in performance but just a few about the cognitive processes while walking. The aim of this study is to investigate the change in gait automaticity in pwMS by analyzing the hemodynamic response in the prefrontal cortex (PFC) applying functional near-infrared spectroscopy (fNIRS).
Methods/Design
This study will focus on the test-retest reliability, the reliability of the measurement protocol and on differentiating between pwMS and healthy controls (HC) as there are to the best of our knowledge no studies addressing these issues. Therefore, all participants (20 pwMS/20 HC) will walk a 12 m track back and forth over 6 min while concentrating on walking only in a quite environment on two consecutive days. The hemodynamic response (fNIRS), gait parameters (inertial measurement units), questionnaires on fatigue and subjective walking ability as well as the 6-min walk test and the qualitative motion analysis by experts (video) for the assessment of fatigability will be monitored.
Discussion/Conclusion
There are many attempts to capture cognitive processes through dual-task while walking, but there is only one study that actually measures the PFC activation using fNIRS in pwMS while walking. Understanding these cognitive processes is essential in order to be able to evaluate therapy strategies as well as to improve patients' self-assessment to reduce the risk of falls induced by MS-related gait deficits.

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Organizational Data

  •   DRKS00015190
  •   2018/11/23
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  •   yes
  •   Approved
  •   116/18, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

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Health Condition or Problem studied

  •   G35 -  Multiple sclerosis
  •   healthy people
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Interventions/Observational Groups

  •   Observation group:
    Adults (n = 20) aged 18-60 years with a confirmed MS diagnosis and an EDSS of 4.5 or less are included in the study. Before the main measurements start the level of fatigability is determined by applying the modified 6-minute walk test according to Leone et al. (2016). The test setting is performed on two different days with at least 24 hours in between at the same time of day. The subjects walk up and down a flat 30 m track for a total of 12:30 min. The prefrontal activation (right / left dorsolateral prefrontal cortex (Brodmann area (BA) 9 and 46), right / left frontopolar cortex (BA10) and right / left pars triangular of the ​​Broca area (BA45)) during walking is measured by means of the portable functional near infrared spectroscopy system. To partial systemic artifacts out, the pulse is also recorded during the measurement. The fNIRS technology is an attempt to better understand gait automaticity and the influence of fatigability. In addition, classical gait parameters (walking speed, double-step length and minimum toe clearance) are recorded by intertial sensors. Questionnaires (FMSC and 12-MSWS) are used to assess fatigue and the subjective walking abilities.
  •   Control Group:
    The control group (n = 20) should be age-matched to the observation group and undergo the same test procedure.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

In this study, a portable fNIRS system (NIRSport, NIRx Medical Technologies, NY, USA) will be used to assess the hemodynamic response of the prefrontal cortex. The exact areas captured are the right and left dorsolateral prefrontal cortex (DLPFC) (Brodmann area (BA) 9&46), the right and left frontopolar cortex (FPC) (BA10) and the right and left pars triangularis of the Broca areal (BA45). Therefore, the primary outcome is the oxyHb and the deoxyHb concentrations in those areas.
Capturing fatigability is still challenging as there is a lack of reference data. Hence, we will use two different methods to make a rough categorization of whether patients have fatigability or not. The first method is the modified 6-min walking test Leone et al. 2016. Here, care will be taken not only to record the distance of the entire six minutes, but also the distance of every single minute. Based on these values the “distance walked index (DWI=([distance walked at minute n−distance walked at minute1]/distance walked at minute1)×100)” (Leone et al. 2016) will be calculated.
The second method to categorize will be the expert meaning that is predicated on the videos made during the measurements (GoPro Hero 4, GoPro Inc., CA, USA). Based on predefined criteria, the videos will be evaluated for indications of fatigability by two independent observers (health professionals).

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Secondary Outcome

As complementary information, the socio-demographic (age and sex), anthropometric (height and weight) and disease-specific data (years since first onset of the disease, years since first diagnosis of the disease, MS-type and expanded disability status scale (EDSS)) will be listed for all patients.
Before the measurements take place, the patients have to fill out two questionnaires. First, we will evaluate the patients’ self-report of their walking abilities by using the German version of the MSWS-12.
The second questionnaire, the German version of the “Fatigue Scale for Motor and Cognitive function” (Penner et al. 2009), is designed to estimate the subjective level of Fatigue.

In order to not only record the hemodynamic response with the fNIRS, but also to be able to assess whether motor changes occur during the measurements, a standard gait analysis will be performed. Here, the outcome parameters of interest are double step length (DSL), gait velocity and the minimum toe clearance (MTC) as they are all indicators for a stable gait pattern.
Additionally, the subjective exertion will be queried with the Borg scale before and after the measurements. During the whole measurement the heart rate will be assessed by a pulse watch (RS800CX Polar Electro Oy ®, Kempele, Finland). The outcome parameters are the mean heart rate and low frequency/high frequency band (LF/HF) ration calculated with the “Kubios HRV” software (Biosignal Analysis and Medical Imaging Group, University Kuopio, Finland; Version 2.2).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2019/06/01
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

1. Inclusion criteria multiple sclerosis patients:
- 18-60 years
- secured MS diagnosis according to the revised McDonald criteria of 2010 (Polman et al., 2011)
- Expanded Disability Status Scale (EDSS) 0-4.5 or walking ability of at least 200 m

2. Inclusion criteria healthy control group:
- 18-60 years
- No orthopedic or neurological diseases
- Unlimited walking ability

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Exclusion Criteria

1. MS:
- less than 30 days after acute attack or last cortisone intake
- visual disturbances
- aphasia
- epilepsy
2. Healthy Controls:
- neurological and orthopaedic limitations

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Otto-von-Guericke Universität Magdeburg, Institut III, Bereich Sportwissenschaft
    • Mr.  Prof. Dr.  Lutz   Schega 
    • Gebäude 40 D / Zschokkestr. 32
    • 39104  Magdeburg
    • Germany
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    • MEDIAN Klinik Flechtingen
    • Mr.  Prof. Dr. med.  Michael  Sailer 
    • Gustav-Ricker-Str. 4
    • 39345  Flechtingen
    • Germany
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    • Otto-von-Guericke Universität Magdeburg Bereich Sportwissenschaft
    • Ms.  Kim-Charline  Broscheid 
    • Gebäude 40 D / Zschokkestr. 32
    • 39104  Magdeburg
    • Germany
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    • Otto-von-Guericke Universität Magdeburg Bereich Sportwissenschaft
    • Ms.  Kim-Charline  Broscheid 
    • Gebäude 40 D / Zschokkestr. 32
    • 39104  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Otto-von-Guericke Universität Magdeburg, Institut III, Bereich Sportwissenschaft
    • Mr.  Prof. Dr.  Lutz  Schega 
    • Gebäude 40 D / Zschokkestr. 32
    • 39104  Magdeburg
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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