Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE
- Conditions
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Interventions
- Device: home-based transcranial direct current stimulation (tDCS)
- Registration Number
- NCT05791812
- Lead Sponsor
- University of Regensburg
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- ME/CFS diagnosis according to the Canadian Consensus Criteria
- residence near Regensburg and mother language German
- written informed consent
- stable medication if possible
- contraindications for transcranial direct current stimulation
- certain neurological conditions as assessed by study physician
- participation in another study
- pregnancy and lactation period
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description active treatment home-based transcranial direct current stimulation (tDCS) 2mA of tDCS for 20 min every weekday for six weeks
- Primary Outcome Measures
Name Time Method 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
Number of patients who completed the treatment regularly 6 weeks Number of patients who completed the treatment regularly
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)
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)
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)
- Secondary Outcome Measures
Name Time Method Pittsburgh sleep quality index 18 weeks sleep inventory (0-21, the lower the better)
digital span 18 weeks memory test (percentiles; the higher the better)
Major Depression Inventory 18 weeks Depression inventory (0-50, the lower the better)
numeric analogue scale pain 18 weeks pain scale (0-10, the lower the better)
Clinical Global Impression change 18 weeks Clinical Global Impression (1-7, the lower the better)
d2 test 18 weeks concentration test (percentiles; the higher 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)
Chalder fatigue scale 18 weeks fatigue scale (0-33; the lower the better)
Trial Locations
- Locations (1)
Department of Psychiatry and Psychotherapy, University of Regensburg
🇩🇪Regensburg, Germany