Multiple Sclerosis Clinical Trial
Official title:
Biofeedback-based Relaxation Training or Self-alert Training to Alleviate Fatigue in Multiple Sclerosis Patients.
NCT number | NCT03268187 |
Other study ID # | 009/2017 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 17, 2017 |
Est. completion date | October 18, 2018 |
Verified date | April 2019 |
Source | Rehazentrum Wilhelmshaven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Rehazentrum Wilhelmshaven | Wilhelmshaven | Lower Saxony |
Lead Sponsor | Collaborator |
---|---|
Rehazentrum Wilhelmshaven |
Germany,
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. |
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