FatigueNCT03268187
Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.
A study testing Biofeedback, Self-Alert Training and Relaxation Training in people with Fatigue and Multiple Sclerosis, run by Rehazentrum Wilhelmshaven at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fatigue, Multiple Sclerosis
- What is being tested?
- Biofeedback, Self-Alert Training and Relaxation Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 17 Jul 2017to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- at least a moderate cognitive fatigue (Fatigue Scale for Motor and Cognition minimum 22)
- clinical diagnosis of Multiple Sclerosis
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Fatigue, Multiple Sclerosis
- Being tested
- Biofeedback, Self-Alert Training, Relaxation Training
- Keywords
- Cognitive Fatigue, Multiple Sclerosis, Biofeedback, Self-Alert Training, Vigilance, Autonomic potentials
- Medical subject headings
- Fatigue, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackDevice
The skin conductance of the patient is measured and fed back to the patient via screen.
Self-Alert TrainingBehavioural
Self-Alert Training
Relaxation TrainingBehavioural
Relaxation Training
| Study group | Role | What they receive |
|---|---|---|
| Self-Alert Training | Experimental | Biofeedback-based Self-Alert Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior Receives: Device: Biofeedback; Behavioral: Self-Alert Training |
| Relaxation Training | Active comparator | Biofeedback-based Relaxation Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior Receives: Device: Biofeedback; Behavioral: Relaxation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Time of Vigilance Task (TAP)
Changes of the reaction time in the vigilance task
Measured: 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
Measured: 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
Measured: At day one before the introduction in the training and at day two after the training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start17 Jul 2017
- Primary completion9 Jun 2018
- Study completion18 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehazentrum Wilhelmshaven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carina Sander, Rehazentrum Wilhelmshaven
- Investigators
- Helmut Hildebrandt, Prof, Study director, Carl- von Ossietzky University Oldenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268187
- Sponsor's protocol ID
- 009/2017
- Status last verified
- Apr 2019
- First submitted
- 29 Aug 2017
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.
- ClinicalTrials.gov ID
- NCT03268187
- Acronym / sponsor ID
- 009/2017
- Conditions
- Fatigue, Multiple Sclerosis
- Keywords
- Cognitive Fatigue, Multiple Sclerosis, Biofeedback, Self-Alert Training, Vigilance, Autonomic potentials
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Rehazentrum WilhelmshavenUniversity, hospital or other
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 9 Jun 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Alert Training | Experimental | Device: Biofeedback, Behavioral: Self-Alert TrainingBiofeedback-based Self-Alert Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior |
| Relaxation Training | Active comparator | Device: Biofeedback, Behavioral: Relaxation TrainingBiofeedback-based Relaxation Training Vigilance Task Questionnaires accessing apathy, fatigue, depression, sleep quality, sleep behavior |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- at least a moderate cognitive fatigue (Fatigue Scale for Motor and Cognition minimum 22)
- clinical diagnosis of Multiple Sclerosis
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackThe skin conductance of the patient is measured and fed back to the patient via screen. | Device | Relaxation Training, Self-Alert Training |
| Self-Alert TrainingSelf-Alert Training | Behavioural | Self-Alert Training |
| Relaxation TrainingRelaxation Training | Behavioural | Relaxation Training |
Primary outcome
Reaction Time of Vigilance Task (TAP)
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.
Changes of the reaction time in the vigilance task
Subjective Fatigue (VAS)
Time frame: Before and after the long-term vigilance tasks at day 1 and 2
The current perceived fatigue
1 secondary outcome
Omissions and errors of Vigilance Task (TAP)
Time frame: At day one before the introduction in the training and at day two after the training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Derived from this study: PubMed 32851896Sander 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helmut Hildebrandt, Prof study director
Carl- von Ossietzky University Oldenburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback, Self-Alert Training and Relaxation Training in people with Fatigue and Multiple Sclerosis, run by Rehazentrum Wilhelmshaven at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reaction Time of Vigilance Task (TAP) (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.