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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis; Fatigue
• Intervention / Treatment: Device: Biofeedback; Behavioral: Self-Alert Training; Behavioral: Relaxation Training

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Lower Saxony
    • Wilhelmshaven, Lower Saxony, Germany, 26382
      • Rehazentrum Wilhelmshaven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Rehazentrum Wilhelmshaven
• Investigators: Study Director: Helmut Hildebrandt, Prof, Carl- von Ossietzky University Oldenburg

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2017
• Primary Completion (Actual): June 9, 2018
• Study Completion (Actual): October 18, 2018

Study Registration Dates

• First Submitted: August 29, 2017
• First Submitted That Met QC Criteria: August 30, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Biofeedback; Cognitive Fatigue; Vigilance; Self-Alert Training; Autonomic potentials
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: 009/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No