It is a one-arm open-label interventional study with transcranial direct current stimulation in an remote home-based setting with the aims to evaluate the feasibility (usability of the device, compliance of patients, usability of the teletherapy), the effectiveness (clinical ratings) and the compatability of this intervention in 20 patients with myalgic encephalomyelitis/chronic fatigue syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
2mA of tDCS for 20 min every weekday for six weeks
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, Germany
Usability for the patients
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \[1-7, 26 items, the higher the better\]
Time frame: 6 weeks
Usability for the handlers/clinicians
Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \[1-7, 26 items, the higher the better\]
Time frame: 6 weeks
Number of days out of 30 the patients used the device
Number of days out of 30 the patients used the device
Time frame: 6 weeks
Number of patients who completed the treatment regularly
Number of patients who completed the treatment regularly
Time frame: 6 weeks
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Number of responders according the the clinical global impression change score for patients in the per protocol analysis (range: 1-7; the lower the better)
Time frame: 6 weeks
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score
Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score (fatigue scale; 0-100; the higher the better)
Time frame: 6 weeks
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale
Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale (fatigue scale; 0-33; the lower the better)
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Time frame: 6 weeks
Major Depression Inventory
Depression inventory (0-50, the lower the better)
Time frame: 18 weeks
World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Quality of life scale inventory (4-20, the higher the better)
Time frame: 18 weeks
Clinical Global Impression change
Clinical Global Impression (1-7, the lower the better)
Time frame: 18 weeks
Pittsburgh sleep quality index
sleep inventory (0-21, the lower the better)
Time frame: 18 weeks
numeric analogue scale pain
pain scale (0-10, the lower the better)
Time frame: 18 weeks
d2 test
concentration test (percentiles; the higher the better)
Time frame: 18 weeks
digital span
memory test (percentiles; the higher the better)
Time frame: 18 weeks
Chalder fatigue scale
fatigue scale (0-33; the lower the better)
Time frame: 18 weeks
Bell score
fatigue scale (0-100; the higher the better)
Time frame: 18 weeks