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

Condition(s) studied

Investigational drug(s) / intervention(s)

home-based transcranial direct current stimulation (tDCS): 2mA of tDCS for 20 min every weekday for six weeks

Study 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.

Eligibility

Primary outcome measure(s)

• 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
• 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)
• 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)

Trial sites (1)

More University of Regensburg trials in Germany