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Active, Not Recruiting

NCT Number: NCT05791812

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based transcranial direct current stimulation (tDCS)

Device

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

Primary outcomes

  1. 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]

  2. 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]

  3. 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

  4. Number of patients who completed the treatment regularly

    Time frame: 6 weeks

    Number of patients who completed the treatment regularly

  5. 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)

  6. 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)

  7. 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)

Secondary outcomes

  1. Major Depression Inventory

    Time frame: 18 weeks

    Depression inventory (0-50, the lower the better)

  2. World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)

    Time frame: 18 weeks

    Quality of life scale inventory (4-20, the higher the better)

  3. Clinical Global Impression change

    Time frame: 18 weeks

    Clinical Global Impression (1-7, the lower the better)

  4. Pittsburgh sleep quality index

    Time frame: 18 weeks

    sleep inventory (0-21, the lower the better)

  5. numeric analogue scale pain

    Time frame: 18 weeks

    pain scale (0-10, the lower the better)

  6. d2 test

    Time frame: 18 weeks

    concentration test (percentiles; the higher the better)

  7. digital span

    Time frame: 18 weeks

    memory test (percentiles; the higher the better)

  8. Chalder fatigue scale

    Time frame: 18 weeks

    fatigue scale (0-33; the lower the better)

  9. Bell score

    Time frame: 18 weeks

    fatigue scale (0-100; the higher the better)

Sponsors and collaborators

Lead sponsor

University of Regensburg

Other

Registry information

Official study title

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

Acronym: ACTIVATE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Mar 30, 2023
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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