NCT05791812

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 16, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

March 17, 2023

Last Update Submit

September 18, 2025

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Keywords

transcranial direct current stimulation

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • Number of days out of 30 the patients used the device

    Number of days out of 30 the patients used the device

    6 weeks

  • Number of patients who completed the treatment regularly

    Number of patients who completed the treatment regularly

    6 weeks

  • 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

  • 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

  • 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 Outcomes (9)

  • Major Depression Inventory

    18 weeks

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

    18 weeks

  • Clinical Global Impression change

    18 weeks

  • Pittsburgh sleep quality index

    18 weeks

  • numeric analogue scale pain

    18 weeks

  • +4 more secondary outcomes

Study Arms (1)

active treatment

EXPERIMENTAL

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

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

Interventions

home-based transcranial direct current stimulation (tDCS)DEVICE

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

active treatment

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ME/CFS diagnosis according to the Canadian Consensus Criteria
  • residence near Regensburg and mother language German
  • written informed consent
  • stable medication if possible

You may not qualify if:

  • contraindications for transcranial direct current stimulation
  • certain neurological conditions as assessed by study physician
  • participation in another study
  • pregnancy and lactation period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, 93055, Germany

Location

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesEncephalomyelitisNeuroinflammatory DiseasesNervous System DiseasesNeuromuscular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Berthold Langguth

    University of Regensburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor, MD, Ph.D.

Study Record Dates

First Submitted

March 17, 2023

First Posted

March 30, 2023

Study Start

March 16, 2023

Primary Completion

November 30, 2025

Study Completion

March 31, 2026

Last Updated

September 19, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

On demand possible.

Locations

DE(1)