COVID-19NCT04944147
Cognitive Training and Brain Stimulation in Patients With Post-COVID-19 Cognitive Impairment
A study testing Anodal tDCS, Intensive cognitive training and Progressive muscle relaxation (PMR) in people with COVID-19 and Post-COVID-19, run by University Medicine Greifswald at 1 site in Germany.
Trial summary
The aim of the study is to investigate effects of brain stimulation-assisted cognitive training in patients with persistent subjective or objective cognitive impairment after polymerase chain reaction (PCR)-positive COVID-19 disease. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- COVID-19, Post-COVID-19
- What is being tested?
- Anodal tDCS, Intensive cognitive training and Progressive muscle relaxation (PMR)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 5 Jan 2022to 8 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- History of COVID-19 condition at least 4-6 weeks prior to study inclusion
- Self-reported concerns regarding cognitive functioning.
- Age: 18-60 years.
Who cannot join
- Acute COVID-19 illness.
- History of dementia before COVID-19.
- Other neurodegenerative neurological disorders; epilepsy or history of seizures.
- Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
- History of severe alcoholism or use of drugs.
- Severe psychiatric disorders such as severe depression (if not in remission) or psychosis.
- Contraindication to tDCS application (Antal et al. 2017).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-COVID-19 Cognitive Impairment
The aim of the study is to investigate effects of brain stimulation-assisted cognitive training in patients with persistent subjective or objective cognitive impairment after polymerase chain reaction (PCR)-positive COVID-19 disease.
Read the detailed description
Long-term persistent symptoms occur in a substantial number of patients diagnosed with coronavirus 2019 disease (COVID-19). First evidence suggests that long-term symptoms develop not only after severe courses of the disease, but also after less serious illness and include various symptoms such as fatigue and impaired memory, concentration or sleep. During recovery, these symptoms present a heavy burden for patients, who then often experience psychological distress and reduced quality of life. The goal of the present study is to assess the effects of cognitive training alone or in combination with tDCS on cognitive performance, quality of life and mental health in patients with subjective or objective cognitive impairments following post-COVID disease. Patients will either participate in a three-week cognitive training with concurrent online high-definition tDCS application or placebo ("sham") tDCS or participate in an evidence-based muscle relaxation training combined with placebo tDCS. We hypothesize that cognitive training with sham or active tDCS will result in more pronounced improvement on a transfer task compared to the control group. We also hypothesize that training combined with anodal tDCS will lead to significantly higher performance on a transfer task than training combined with sham tDCS. Additionally, we will determine effects on specifically trained and other untrained cognitive functions immediately after the intervention as well as their maintenance one month later.
- Conditions
- COVID-19, Post-COVID-19
- Being tested
- Anodal tDCS, Sham tDCS, Intensive cognitive training, Progressive muscle relaxation (PMR)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal tDCSDevice
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)
Sham tDCSDevice
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants
Intensive cognitive trainingBehavioural
Intensive cognitive training of a letter memory updating task, 9 sessions
Progressive muscle relaxation (PMR)Behavioural
Standardized instructed PMR training, 9 sessions
| Study group | Role | What they receive |
|---|---|---|
| Anodal tDCS + cognitive training | Experimental | device: anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA) over left dorsolateral prefrontal cortex
behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions Receives: Device: Anodal tDCS; Behavioral: Intensive cognitive training |
| Sham tDCS + cognitive training | Placebo comparator | device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex
behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions Receives: Device: Sham tDCS; Behavioral: Intensive cognitive training |
| Sham tDCS + Progressive Muscle Relaxation training | Active comparator | device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex
behavioral: progressive muscle relaxation (PMR) standardized instructed PMR (20 minutes), 9 sessions Receives: Device: Sham tDCS; Behavioral: Progressive muscle relaxation (PMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory performance at post-assessment
Percent change of correct responses in the n-back task compared to the pre-training assessment.
Measured: 3 weeks
Secondary outcomes (9)
Working memory performance at follow-up assessment
Percent change of correct responses in the n-back task compared to the pre-training assessment.
Measured: 4 weeks after training
Working memory training performance (Letter Updating Task) at post-assessment
Performance in primary memory training task (Letter Updating Task) at post-assessment, operationalized by number of correctly recalled lists in the letter updating task.
Measured: 3 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment
Performance in primary memory training task (Letter Updating Task) at follow-up assessment, operationalized by number of correctly recalled lists in the letter updating task.
Measured: 4 weeks after training
Quality of Life at post-assessment
PROMIS (Patient-Reported Outcome Measures and Health-Related Quality of Life) score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function). Every item is rated on scale from 1 to 5, the higher the score the worse the self-reported health evaluation.
Measured: 3 weeks
Quality of Life at follow-up assessment
PROMIS (Patient-Reported Outcome Measures and Health-Related Quality of Life) score for HRQoL (PROPr score) and scores of subscales (e.g. cognitive function). Every item is rated on scale from 1 to 5, the higher the score the worse the self-reported health evaluation.
Measured: 4 weeks after training
Visuo-spatial performance at post-assessment
Visuo-spatial performance at post-assessment operationalized by number of correctly recalled items in the VR task.
Measured: 3 weeks
Visuo-spatial performance at follow-up assessment
Visuo-spatial performance at follow-up assessment operationalized by number of correctly recalled items in the VR task.
Measured: 4 weeks after training
Post COVID-19 Function at post-assessment
Scores of Post COVID-19 Functional Scale (PCFS). PCFS scale grad from 0 (no functional limitations) to 4 (severe functional limitations).
Measured: 3 weeks
Post COVID-19 Function at follow-up assessment
Scores of Post COVID-19 Functional Scale (PCFS). PCFS scale grad from 0 (no functional limitations) to 4 (severe functional limitations).
Measured: 4 weeks after training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start5 Jan 2022
- Primary completion9 Sep 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agnes Flöel, Prof., Study director, University Medicine Greifswald
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944147
- Sponsor's protocol ID
- Neuromod-COV
- Status last verified
- Dec 2024
- First submitted
- 28 Jun 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized data will be made available to the scientific community upon request.
Publications
Thams F, Antonenko D, Fleischmann R, Meinzer M, Grittner U, Schmidt S, Brakemeier EL, Steinmetz A, Floel A. Neuromodulation through brain stimulation-assisted cognitive training in patients with post-COVID-19 cognitive impairment (Neuromod-COV): study protocol for a PROBE phase IIb trial. BMJ Open. 2022 Apr 11;12(4):e055038. doi: 10.1136/bmjopen-2021-055038.
PubMed 35410927
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-COVID-19 Cognitive Impairment
- ClinicalTrials.gov ID
- NCT04944147
- Acronym / sponsor ID
- Neuromod-COV
- Conditions
- COVID-19, Post-COVID-19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 9 Sep 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 29 Jun 2021 (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.
The aim of the study is to investigate effects of brain stimulation-assisted cognitive training in patients with persistent subjective or objective cognitive impairment after polymerase chain reaction (PCR)-positive COVID-19 disease.
Detailed description
Long-term persistent symptoms occur in a substantial number of patients diagnosed with coronavirus 2019 disease (COVID-19). First evidence suggests that long-term symptoms develop not only after severe courses of the disease, but also after less serious illness and include various symptoms such as fatigue and impaired memory, concentration or sleep. During recovery, these symptoms present a heavy burden for patients, who then often experience psychological distress and reduced quality of life. The goal of the present study is to assess the effects of cognitive training alone or in combination with tDCS on cognitive performance, quality of life and mental health in patients with subjective or objective cognitive impairments following post-COVID disease. Patients will either participate in a three-week cognitive training with concurrent online high-definition tDCS application or placebo ("sham") tDCS or participate in an evidence-based muscle relaxation training combined with placebo tDCS. We hypothesize that cognitive training with sham or active tDCS will result in more pronounced improvement on a transfer task compared to the control group. We also hypothesize that training combined with anodal tDCS will lead to significantly higher performance on a transfer task than training combined with sham tDCS. Additionally, we will determine effects on specifically trained and other untrained cognitive functions immediately after the intervention as well as their maintenance one month later.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anodal tDCS + cognitive training | Experimental | Device: Anodal tDCS, Behavioral: Intensive cognitive trainingdevice: anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions |
| Sham tDCS + cognitive training | Placebo comparator | Device: Sham tDCS, Behavioral: Intensive cognitive trainingdevice: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: intensive cognitive training intensive cognitive training of letter memory updating task (20 minutes), 9 sessions |
| Sham tDCS + Progressive Muscle Relaxation training | Active comparator | Device: Sham tDCS, Behavioral: Progressive muscle relaxation (PMR)device: sham transcranial direct current stimulation (tDCS), 9 sessions with 30 seconds stimulation each (2 mA) over left dorsolateral prefrontal cortex behavioral: progressive muscle relaxation (PMR) standardized instructed PMR (20 minutes), 9 sessions |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- History of COVID-19 condition at least 4-6 weeks prior to study inclusion
- Self-reported concerns regarding cognitive functioning.
- Age: 18-60 years.
Key exclusion criteria (7 listed)
- Acute COVID-19 illness.
- History of dementia before COVID-19.
- Other neurodegenerative neurological disorders; epilepsy or history of seizures.
- Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
- History of severe alcoholism or use of drugs.
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 |
|---|---|---|
| Anodal tDCSAnodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA) | Device | Anodal tDCS + cognitive training |
| Sham tDCSSham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants | Device | Sham tDCS + Progressive Muscle Relaxation training, Sham tDCS + cognitive training |
| Intensive cognitive trainingIntensive cognitive training of a letter memory updating task, 9 sessions | Behavioural | Anodal tDCS + cognitive training, Sham tDCS + cognitive training |
| Progressive muscle relaxation (PMR)Standardized instructed PMR training, 9 sessions | Behavioural | Sham tDCS + Progressive Muscle Relaxation training |
Primary outcome
Working memory performance at post-assessment
Time frame: 3 weeks
Percent change of correct responses in the n-back task compared to the pre-training assessment.
9 secondary outcomes
Working memory performance at follow-up assessment
Time frame: 4 weeks after training
Working memory training performance (Letter Updating Task) at post-assessment
Time frame: 3 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment
Time frame: 4 weeks after training
Quality of Life at post-assessment
Time frame: 3 weeks
Quality of Life at follow-up assessment
Time frame: 4 weeks after training
Visuo-spatial performance at post-assessment
Time frame: 3 weeks
Visuo-spatial performance at follow-up assessment
Time frame: 4 weeks after training
Post COVID-19 Function at post-assessment
Time frame: 3 weeks
Post COVID-19 Function at follow-up assessment
Time frame: 4 weeks after training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 35410927Thams F, Antonenko D, Fleischmann R, Meinzer M, Grittner U, Schmidt S, Brakemeier EL, Steinmetz A, Floel A. Neuromodulation through brain stimulation-assisted cognitive training in patients with post-COVID-19 cognitive impairment (Neuromod-COV): study protocol for a PROBE phase IIb trial. BMJ Open. 2022 Apr 11;12(4):e055038. doi: 10.1136/bmjopen-2021-055038.
- Individual participant dataSharing planned: Yes. Anonymized data will be made available to the scientific community upon request.
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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.
Agnes Flöel, Prof. study director
University Medicine Greifswald
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal tDCS, Intensive cognitive training and Progressive muscle relaxation (PMR) in people with COVID-19 and Post-COVID-19, run by University Medicine Greifswald 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 5 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Working memory performance at post-assessment (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04944147, which also lists 1 linked publication.
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 5 Dec 2024.