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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active treatment | Experimental | 2mA of tDCS for 20 min every weekday for six weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| home-based transcranial direct current stimulation (tDCS) | Device | 2mA of tDCS for 20 min every weekday for six weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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] | 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] | 6 weeks |
| Number of days out of 30 the patients used the device | Number of days out of 30 the patients used the device | 6 weeks |
| Number of patients who completed the treatment regularly | Number of patients who completed the treatment regularly | 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) | 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) | 6 weeks |
| Effect size for change of fatigue for patients in the per protocol analysis measured with the Chalder Fatigue Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Major Depression Inventory | Depression inventory (0-50, the lower the better) | 18 weeks |
| World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF) | Quality of life scale inventory (4-20, the higher the better) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berthold Langguth | University of Regensburg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy, University of Regensburg | Regensburg | 93055 | Germany |
On demand possible.
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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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) |
| 6 weeks |
| 18 weeks |
| Clinical Global Impression change | Clinical Global Impression (1-7, the lower the better) | 18 weeks |
| Pittsburgh sleep quality index | sleep inventory (0-21, the lower the better) | 18 weeks |
| numeric analogue scale pain | pain scale (0-10, the lower the better) | 18 weeks |
| d2 test | concentration test (percentiles; the higher the better) | 18 weeks |
| digital span | memory test (percentiles; the higher the better) | 18 weeks |
| Chalder fatigue scale | fatigue scale (0-33; the lower the better) | 18 weeks |
| Bell score | fatigue scale (0-100; the higher the better) | 18 weeks |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |