Repetitive frontal home-based transcranial direct current stimulation (tDCS) als a potential treatment for long-COVID-related fatigue
Organizational Data
- DRKS-ID:
- DRKS00033161
- Recruitment Status:
- Recruiting planned
- Date of registration in DRKS:
- 2023-11-29
- Last update in DRKS:
- 2023-11-29
- Registration type:
- Prospective
Acronym/abbreviation of the study
LCOF Home
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Non-invasive brain stimulation could be a potential non-pharmacologic, affordable and easy-to-use treatment for the underlying pathologic brainphysiology. There is already a variety of research focusing on the influence of tDCS of the dorsolateral prefrontal cortex (dlPFC) on fatigue in healthy subjects as well as in patients with multiple sclerosis (Linnhoff et al., 2022, Fiene et al., 2018, Kan et al., 2022) and other psychiatric diseases (Kalu et al., 2012) with promising results. A case study by Gómez et al. (2021) gives first hints on the effectiveness of tDCS on long-COVID-Fatigue. There is further evidence for superior effects of repetitive stimulation (see Linnhoff et al., 2019, Kan et al., 2022). These findings lead us the question whether we can improve fatigue in long-COVID-patients with repetitive home-based tDCS of the left dlPFC in 29 stimulation sessions. Subjective and objective parameters of fatigue, as well as associated EEG-components are assessed before and after four sessions of tDCS. Potential long-term effects of the stimulation are assessed four weeks later.
Health condition or problem studied
- Free text:
- Long-COVID patients with cognitive fatigue; U09.9!
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- 29 sessions anodal tDCS over the left dlPFC; 1.5mA, 30 minutes each
- Arm 2:
- 29 sessions sham tDCS over the left dlPFC; 30 minutes each
Endpoints
- Primary outcome:
- Improvement of subjective fatigue (MFIS; total and subscales) by repetitive verum tDCS Assessment: Directly before to max. two days before the first stimulation (pre), one day after the last stimulation (post), one month after the last stimulation (follow-up)
- Secondary outcome:
- - Improvement in quality of life (EQ-5D-5L) - Improvement in subjective state fatigue (VAS) - Improvement of objective fatigability parameters (behavioral data) - Influence on fatigability-associated EEG components: Alpha, Theta, P50 Assessment: Directly before or max. two days before the first stimulation (pre), one day after the last stimulation (post), one month after the last stimulation (follow-up)
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Placebo
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting planned
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Magdeburg
Recruitment period and number of participants
- Planned study start date:
- 2023-12-01
- Actual study start date:
- No Entry
- Planned study completion date:
- 2025-02-01
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 40
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- - cognitive fatigue (WeiMUS cognitive scale >= 17) - positive SARS-CoV-2-finding (COVID-19), at least 3 months old
Exclusion Criteria
- diagnose of depression or anxiety disorder, other psychiatric disorders - medication with antidepressants, opioids, anticonvulsants - neurological disorders
Addresses
Primary Sponsor
- Address:
- Otto-von-Guericke-Universität Magdeburg, med. Fakultät, Universitätsklinik für Neurologie, Sektion NeuropsychologieProf. Dr. Tino Zähle39120 MagdeburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Otto-von-Guericke-Universität Magdeburg, med. Fakultät, Universitätsklinik für Neurologie, Sektion NeuropsychologieM.Sc. Magdalena MischkeLeipziger Str. 44 Haus 60b39120 MagdeburgGermany
- Telephone:
- 0391 67 21683
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Otto-von-Guericke-Universität Magdeburg, med. Fakultät, Universitätsklinik für Neurologie, Sektion NeuropsychologieM.Sc. Magdalena MischkeLeipziger Str. 44 Haus 60b39120 MagdeburgGermany
- Telephone:
- 0391 67 21683
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Otto-von-Guericke-Universität Magdeburg, med. Fakultät, Universitätsklinik für Neurologie, Sektion NeuropsychologieM.Sc. Magdalena MischkeLeipziger Str. 44 Haus 60b39120 MagdeburgGermany
- Telephone:
- 0391 67 21683
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Ministerium für Wissenschaft, Energie, Klimaschutz und Umwelt des Landes Sachsen-AnhaltPostfach 376239112 MagdeburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.Leipziger Str. 44 Haus 2839120 MagdeburgGermany
- Telephone:
- +49-391-6714314
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ethikkommission.ovgu.de/
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2023-04-21
- Ethics committee number:
- 83/18
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2023-05-12
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- Yes
- IPD Sharing Plan:
- Deidentificated individual participant data will be available to researchers who provide a methodolically sound proposal. Proposals should be directed to magdalena.mischke@med.ovgu.de. To gain access, requestors will need to sign a data access agreement. Data will be available from two months following publication up to 24 months following publication.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry