Myalgic Encephalomyelitis/Chronic Fatigue SyndromeACTIVATENCT05791812
Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE
A study testing home-based transcranial direct current stimulation (tDCS) in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by University of Regensburg at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
- What is being tested?
- home-based transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ME/CFS diagnosis according to the Canadian Consensus Criteria
- residence near Regensburg and mother language German
- written informed consent
- stable medication if possible
Who cannot join
- contraindications for transcranial direct current stimulation
- certain neurological conditions as assessed by study physician
- participation in another study
- pregnancy and lactation period
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, 93055
About this study
Official title: 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.
- Being tested
- home-based transcranial direct current stimulation (tDCS)
- Keywords
- transcranial direct current stimulation
- Medical subject headings
- Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based transcranial direct current stimulation (tDCS)Device
2mA of tDCS for 20 min every weekday for six weeks
| Study group | Role | What they receive |
|---|---|---|
| active treatment | Experimental | 2mA of tDCS for 20 min every weekday for six weeks Receives: Device: home-based transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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]
Measured: 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]
Measured: 6 weeks
Number of days out of 30 the patients used the device
Number of days out of 30 the patients used the device
Measured: 6 weeks
Number of patients who completed the treatment regularly
Number of patients who completed the treatment regularly
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 weeks
Secondary outcomes (9)
Major Depression Inventory
Depression inventory (0-50, the lower the better)
Measured: 18 weeks
World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Quality of life scale inventory (4-20, the higher the better)
Measured: 18 weeks
Clinical Global Impression change
Clinical Global Impression (1-7, the lower the better)
Measured: 18 weeks
Pittsburgh sleep quality index
sleep inventory (0-21, the lower the better)
Measured: 18 weeks
numeric analogue scale pain
pain scale (0-10, the lower the better)
Measured: 18 weeks
d2 test
concentration test (percentiles; the higher the better)
Measured: 18 weeks
digital span
memory test (percentiles; the higher the better)
Measured: 18 weeks
Chalder fatigue scale
fatigue scale (0-33; the lower the better)
Measured: 18 weeks
Bell score
fatigue scale (0-100; the higher the better)
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start16 Mar 2023
- Primary completion30 Nov 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myalgic Encephalomyelitis/Chronic Fatigue SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791812
- Sponsor's protocol ID
- 22-3028-101
- Acronym
- ACTIVATE
- Status last verified
- Sep 2025
- First submitted
- 17 Mar 2023
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: On demand possible.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Direct Current Transcranial stImulation, Remotely superVised in Chronic fATiguE - Heimanwendung Der Transkraniellen Gleichstromstimulation Zur Behandlung Der Chronischen Fatigue
- ClinicalTrials.gov ID
- NCT05791812
- Acronym / sponsor ID
- ACTIVATE / 22-3028-101
- Keywords
- transcranial direct current stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 16 Mar 2023 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| active treatment | Experimental | Device: home-based transcranial direct current stimulation (tDCS)2mA of tDCS for 20 min every weekday for six weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ME/CFS diagnosis according to the Canadian Consensus Criteria
- residence near Regensburg and mother language German
- written informed consent
- stable medication if possible
Key exclusion criteria (4 listed)
- contraindications for transcranial direct current stimulation
- certain neurological conditions as assessed by study physician
- participation in another study
- pregnancy and lactation period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based transcranial direct current stimulation (tDCS)2mA of tDCS for 20 min every weekday for six weeks | Device | active treatment |
Primary outcome
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]
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]
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
Number of patients who completed the treatment regularly
Time frame: 6 weeks
Number of patients who completed the treatment regularly
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)
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)
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)
9 secondary outcomes
Major Depression Inventory
Time frame: 18 weeks
World Health Organisation Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Time frame: 18 weeks
Clinical Global Impression change
Time frame: 18 weeks
Pittsburgh sleep quality index
Time frame: 18 weeks
numeric analogue scale pain
Time frame: 18 weeks
d2 test
Time frame: 18 weeks
digital span
Time frame: 18 weeks
Chalder fatigue scale
Time frame: 18 weeks
Bell score
Time frame: 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No. On demand possible.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based transcranial direct current stimulation (tDCS) in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability for the patients (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.