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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fatigue, Multiple Sclerosis

Intervention / Treatment
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* Device: Biofeedback
* Behavioral: Self-Alert Training
* Behavioral: Relaxation Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least a moderate cognitive fatigue (Fatigue Scale for Motor and Cognition minimum 22) clinical diagnosis of Multiple Sclerosis 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-Alert Training<br>Biofeedback-based Self-Alert Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior | Device: Biofeedback<br>* The skin conductance of the patient is measured and fed back to the patient via screen.<br>Behavioral: Self-Alert Training<br>* Self-Alert Training<br>|
| Active Comparator: Relaxation Training<br>Biofeedback-based Relaxation Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior | Device: Biofeedback<br>* The skin conductance of the patient is measured and fed back to the patient via screen.<br>Behavioral: Relaxation Training<br>* Relaxation Training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction Time of Vigilance Task (TAP) | Changes of the reaction time in the vigilance task | Vigilance is measured at the beginning of the first day before the training introduction as well as after the training at the second day. | 
| Subjective Fatigue (VAS) | The current perceived fatigue | Before and after the long-term vigilance tasks at day 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omissions and errors of Vigilance Task (TAP) | The number of omissions and errors made in the Vigilance Task | At day one before the introduction in the training and at day two after the training. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Fatigue, Multiple Sclerosis, Biofeedback, Self-Alert Training, Vigilance, Autonomic potentials