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

University of Regensburg (UR)

Status: Enrolling

Conditions: Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Treatments: Device: home-based transcranial direct current stimulation (tDCS)

Study type: Interventional

Funder types: Other

Identifiers

NCT05791812

22-3028-101

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

active treatment

Experimental group

Description:

2mA of tDCS for 20 min every weekday for six weeks

Treatment:

Device: home-based transcranial direct current stimulation (tDCS)