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CompletedNCT03268187Updated Apr 11, 2019

Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.

An interventional study of Biofeedback and Self-Alert Training in Fatigue and Multiple Sclerosis, sponsored by Rehazentrum Wilhelmshaven. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2019-04-11.

Sponsored by Rehazentrum Wilhelmshaven · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Sex
All
01

Study summary

The presented study compares the effectiveness of a biofeedback-based relaxation training with the effectiveness of a biofeedback-based self-alert training on the reduction of fatigue in multiple sclerosis patients using a between groups design. Furthermore, the relation of fatigue in multiple sclerosis patients and autonomic potentials as well as the performance in a vigilance task will be examined.

The relaxation training is based on the principle of progressive muscle relaxation according to Jacobsen. The patient is asked to tense all muscles in their face and perceive consciously the relaxation afterwards according to verbal cues. In the self-alert training condition, the patient will hear verbal cues to increase their attention. In both conditions the external cues given will be reduced in four phases until the patient has to cue himself. The patient is advised to track the changes in the skin resistance mirrored by biofeedback on a screen.

In both conditions the training will be split on two days. During the whole examination heart rate and skin resistance will be recorded. The allocation to the training happens randomly. On the first day the patient will complete questionnaires to survey depression and apathy and do a baseline vigilance task. Before and after the vigilance task the current fatigue status will be assessed using a visual analogue scale. Afterwards an introduction in the treatment method will be given.

On the second day the introduction into the training will be repeated. Afterwards a short time vigilance task will be done and questionnaires to survey fatigue and sleep behaviour and quality will be completed. Subsequently the last part of the training (no external cues) will be done. The examination will be completed by a long-time vigilance task. Before and after the vigilance task the current fatigue status will be assessed using a visual analogue scale.

It is hypothesised that especially the biofeedback-based self-alert training has a positive effect on fatigue and the vigilance performance in multiple sclerosis patients, as it increases the ectodermal activity and increases the sympathetic activation. It was shown that phasic changes of the skin resistance are correlated with an increase of neuronal activity in the brain areas relevant for vigilance (Critchley et al., 2002; Nagai et al., 2004). The relaxation training will reduce the sympatho-adrenergic excitation disposition and reduce the level of activity. Consequently, we do not expect an alleviation of the perceived fatigue according to our underlying model (Hanken et al., 2016). In addition, it is hypothesized that, independent from the treatment, autonomic potentials correlate with fatigue.

02

Conditions studied

  • Fatigue
  • Multiple Sclerosis

Keywords

  • Cognitive Fatigue
  • Multiple Sclerosis
  • Biofeedback
  • Self-Alert Training
  • Vigilance
  • Autonomic potentials
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • at least a moderate cognitive fatigue (Fatigue Scale for Motor and Cognition minimum 22)
  • clinical diagnosis of Multiple Sclerosis

Exclusion criteria

Exclusion Criteria:

  • psychiatric conditions independent from Multiple Sclerosis
  • Pregnancy
  • regular intake of psychostimulants
  • no relapse in the last four weeks before
  • no cortisone therapy in the last four weeks before
  • patients with schizophrenia or serious personality disorders
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Self-Alert Training

    Biofeedback-based Self-Alert Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior

    Device: Biofeedback · Behavioral: Self-Alert Training

  • Active comparator
    Relaxation Training

    Biofeedback-based Relaxation Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior

    Device: Biofeedback · Behavioral: Relaxation Training

Interventions

  • DeviceBiofeedback

    The skin conductance of the patient is measured and fed back to the patient via screen.

  • BehavioralSelf-Alert Training

    Self-Alert Training

  • BehavioralRelaxation Training

    Relaxation Training

05

What researchers measure

Primary outcomes

  1. Reaction Time of Vigilance Task (TAP)

    Changes of the reaction time in the vigilance task

    Time frame: Vigilance is measured at the beginning of the first day before the training introduction as well as after the training at the second day.

  2. Subjective Fatigue (VAS)

    The current perceived fatigue

    Time frame: Before and after the long-term vigilance tasks at day 1 and 2

Secondary outcomes

  1. Omissions and errors of Vigilance Task (TAP)

    The number of omissions and errors made in the Vigilance Task

    Time frame: At day one before the introduction in the training and at day two after the training.

06

Study locations

1 site
  • Rehazentrum Wilhelmshaven
    Wilhelmshaven, Lower Saxony 26382, Germany
07

References and documents

Publications

  • Sander C, Braun N, Modes F, Schlake HP, Eling P, Hildebrandt H. Can biofeedback-based training alleviate fatigue and vigilance performance in fatigued MS patients? Neuropsychol Rehabil. 2022 Jan;32(1):131-147. doi: 10.1080/09602011.2020.1808023. Epub 2020 Aug 27. PubMed 32851896 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03268187
Lead sponsor
Rehazentrum Wilhelmshaven
Responsible party
Carina Sander (Psychologist, Rehazentrum Wilhelmshaven) — Principal investigator
First posted
Aug 31, 2017
Start date
Jul 17, 2017
Primary completion
Jun 9, 2018
Completion
Oct 18, 2018
Last update
Apr 11, 2019

Study contacts

Helmut Hildebrandt, Prof
study director · Carl- von Ossietzky University Oldenburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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