Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE

Study Overview
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Brief Summary
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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.

Official Title
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Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE - Heimanwendung Der Transkraniellen Gleichstromstimulation Zur Behandlung Der Chronischen Fatigue

Conditions
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Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Intervention / Treatment
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* Device: home-based transcranial direct current stimulation (tDCS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: active treatment<br>2mA of tDCS for 20 min every weekday for six weeks | Device: home-based transcranial direct current stimulation (tDCS)<br>* 2mA of tDCS for 20 min every weekday for six weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation