Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Conditions
Keywords
transcranial direct current stimulation
Brief summary
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.
Interventions
2mA of tDCS for 20 min every weekday for six weeks
Sponsors
University of Regensburg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ME/CFS diagnosis according to the Canadian Consensus Criteria * residence near Regensburg and mother language German * written informed consent * stable medication if possible
Exclusion criteria
* contraindications for transcranial direct current stimulation * certain neurological conditions as assessed by study physician * participation in another study * pregnancy and lactation period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of responders according the the clinical global impression change score for patients in the per protocol analysis | 6 weeks | 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) |
| Number of patients who completed the treatment regularly | 6 weeks | Number of patients who completed the treatment regularly |
| Usability for the patients | 6 weeks | Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \[1-7, 26 items, the higher the better\] |
| Usability for the handlers/clinicians | 6 weeks | Rating of the usability of the treatment (home treatment and video monitoring) with the user experience questionnaire \[1-7, 26 items, the higher the better\] |
| Number of days out of 30 the patients used the device | 6 weeks | Number of days out of 30 the patients used the device |
| Effect size for change of fatigue for patients in the per protocol analysis measured with the Bell Score | 6 weeks | 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) |
| Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale | 6 weeks | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chalder fatigue scale | 18 weeks | fatigue scale (0-33; the lower the better) |
| Major Depression Inventory | 18 weeks | Depression inventory (0-50, the lower the better) |
| Bell score | 18 weeks | fatigue scale (0-100; the higher the better) |
| World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF) | 18 weeks | Quality of life scale inventory (4-20, the higher the better) |
| Clinical Global Impression change | 18 weeks | Clinical Global Impression (1-7, the lower the better) |
| Pittsburgh sleep quality index | 18 weeks | sleep inventory (0-21, the lower the better) |
| numeric analogue scale pain | 18 weeks | pain scale (0-10, the lower the better) |
| d2 test | 18 weeks | concentration test (percentiles; the higher the better) |
| digital span | 18 weeks | memory test (percentiles; the higher the better) |
Countries
Germany
Outcome results
None listed