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

April 4, 2023 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Regensburg, Germany, 93055
        • Recruiting
        • Department of Psychiatry and Psychotherapy, University of Regensburg
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active treatment
2mA of tDCS for 20 min every weekday for six weeks
Device: home-based transcranial direct current stimulation (tDCS)
2mA of tDCS for 20 min every weekday for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
6 weeks
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]
6 weeks
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
6 weeks
Number of patients who completed the treatment regularly
Time Frame: 6 weeks
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
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 weeks
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)
6 weeks
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)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Depression Inventory
Time Frame: 18 weeks
Depression inventory (0-50, the lower the better)
18 weeks
Pittsburgh sleep quality index
Time Frame: 18 weeks
sleep inventory (0-21, the lower the better)
18 weeks
numeric analogue scale pain
Time Frame: 18 weeks
pain scale (0-10, the lower the better)
18 weeks
Chalder fatigue scale
Time Frame: 18 weeks
fatigue scale (0-33; the lower the better)
18 weeks
Bell score
Time Frame: 18 weeks
fatigue scale (0-100; the higher the better)
18 weeks
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)
18 weeks
Clinical Global Impression change
Time Frame: 18 weeks
Clinical Global Impression (1-7, the lower the better)
18 weeks
d2 test
Time Frame: 18 weeks
concentration test (percentiles; the higher the better)
18 weeks
digital span
Time Frame: 18 weeks
memory test (percentiles; the higher the better)
18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Investigators

  • Principal Investigator: Berthold Langguth, University of Regensburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2023

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

January 31, 2025

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

April 7, 2023

Last Update Submitted That Met QC Criteria

April 4, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-3028-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

On demand possible.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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