Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE - Heimanwendung Der Transkraniellen Gleichstromstimulation Zur Behandlung Der Chronischen Fatigue
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- Sponsor
- University of Regensburg
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Usability for the patients
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Berthold Langguth, MD, Ph.D.
Clinical Professor, MD, Ph.D.
University of Regensburg
Eligibility Criteria
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
Outcomes
Primary Outcomes
Usability for the patients
Time Frame: 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
Time Frame: 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
Time Frame: 6 weeks
Number of days out of 30 the patients used the device
Number of patients who completed the treatment regularly
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- digital span(18 weeks)
- Major Depression Inventory(18 weeks)
- numeric analogue scale pain(18 weeks)
- Clinical Global Impression change(18 weeks)
- d2 test(18 weeks)
- Bell score(18 weeks)
- World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)(18 weeks)
- Pittsburgh sleep quality index(18 weeks)
- Chalder fatigue scale(18 weeks)