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

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791812
• Other study ID #: 22-3028-101
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: April 2023
• Source: University of Regensburg
• Contact: Tobias Hebel
• Phone: +49-941-1250
• Email: tobias.hebel[@]medbo.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 31, 2025
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Intervention

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

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of days out of 30 the patients used the device	Number of days out of 30 the patients used the device	6 weeks
Primary	Number of patients who completed the treatment regularly	Number of patients who completed the treatment regularly	6 weeks
Primary	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
Primary	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
Primary	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	Major Depression Inventory	Depression inventory (0-50, the lower the better)	18 weeks
Secondary	World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)	Quality of life scale inventory (4-20, the higher the better)	18 weeks
Secondary	Clinical Global Impression change	Clinical Global Impression (1-7, the lower the better)	18 weeks
Secondary	Pittsburgh sleep quality index	sleep inventory (0-21, the lower the better)	18 weeks
Secondary	numeric analogue scale pain	pain scale (0-10, the lower the better)	18 weeks
Secondary	d2 test	concentration test (percentiles; the higher the better)	18 weeks
Secondary	digital span	memory test (percentiles; the higher the better)	18 weeks
Secondary	Chalder fatigue scale	fatigue scale (0-33; the lower the better)	18 weeks
Secondary	Bell score	fatigue scale (0-100; the higher the better)	18 weeks