Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.
Primary Purpose
Fatigue, Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Biofeedback
Self-Alert Training
Relaxation Training
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring Cognitive Fatigue, Multiple Sclerosis, Biofeedback, Self-Alert Training, Vigilance, Autonomic potentials
Eligibility Criteria
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
Sites / Locations
- Rehazentrum Wilhelmshaven
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Self-Alert Training
Relaxation Training
Arm Description
Biofeedback-based Self-Alert Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior
Biofeedback-based Relaxation Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior
Outcomes
Primary Outcome Measures
Reaction Time of Vigilance Task (TAP)
Changes of the reaction time in the vigilance task
Subjective Fatigue (VAS)
The current perceived fatigue
Secondary Outcome Measures
Omissions and errors of Vigilance Task (TAP)
The number of omissions and errors made in the Vigilance Task
Full Information
NCT ID
NCT03268187
First Posted
August 29, 2017
Last Updated
April 9, 2019
Sponsor
Rehazentrum Wilhelmshaven
1. Study Identification
Unique Protocol Identification Number
NCT03268187
Brief Title
Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.
Official Title
Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
July 17, 2017 (Actual)
Primary Completion Date
June 9, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rehazentrum Wilhelmshaven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Multiple Sclerosis
Keywords
Cognitive Fatigue, Multiple Sclerosis, Biofeedback, Self-Alert Training, Vigilance, Autonomic potentials
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Self-Alert Training
Arm Type
Experimental
Arm Description
Biofeedback-based Self-Alert Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior
Arm Title
Relaxation Training
Arm Type
Active Comparator
Arm Description
Biofeedback-based Relaxation Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior
Intervention Type
Device
Intervention Name(s)
Biofeedback
Intervention Description
The skin conductance of the patient is measured and fed back to the patient via screen.
Intervention Type
Behavioral
Intervention Name(s)
Self-Alert Training
Intervention Description
Self-Alert Training
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Description
Relaxation Training
Primary Outcome Measure Information:
Title
Reaction Time of Vigilance Task (TAP)
Description
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.
Title
Subjective Fatigue (VAS)
Description
The current perceived fatigue
Time Frame
Before and after the long-term vigilance tasks at day 1 and 2
Secondary Outcome Measure Information:
Title
Omissions and errors of Vigilance Task (TAP)
Description
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.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Hildebrandt, Prof
Organizational Affiliation
Carl- von Ossietzky University Oldenburg
Official's Role
Study Director
Facility Information:
Facility Name
Rehazentrum Wilhelmshaven
City
Wilhelmshaven
State/Province
Lower Saxony
ZIP/Postal Code
26382
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32851896
Citation
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.
Results Reference
derived
Learn more about this trial
Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.
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