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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268187
• Other study ID #: 009/2017
• Status: Completed
• Phase: N/A
• Start date: July 17, 2017
• Est. completion date: October 18, 2018

Study information

• Verified date: April 2019
• Source: Rehazentrum Wilhelmshaven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 18, 2018
• Est. primary completion date: June 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Biofeedback
The skin conductance of the patient is measured and fed back to the patient via screen.

Behavioral:
• Self-Alert Training
Self-Alert Training
• Relaxation Training
Relaxation Training

Locations

Country	Name	City	State
Germany	Rehazentrum Wilhelmshaven	Wilhelmshaven	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Rehazentrum Wilhelmshaven

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Subjective Fatigue (VAS)	The current perceived fatigue	Before and after the long-term vigilance tasks at day 1 and 2
Secondary	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.