Cognitive Training and Brain Stimulation in Patients With Post-COVID-19 Cognitive Impairment
Neuromodulation Through Brain Stimulation-assisted Cognitive Training in Patients With Post-COVID-19 Cognitive Impairment
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable covid19
Started Jan 2022
Longer than P75 for not_applicable covid19
1 active site
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
First Submitted
Initial submission to the registry
June 28, 2021
CompletedFirst Posted
Study publicly available on registry
June 29, 2021
CompletedStudy Start
First participant enrolled
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2024
CompletedDecember 5, 2024
December 1, 2024
2.7 years
June 28, 2021
December 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Working memory performance at post-assessment
Percent change of correct responses in the n-back task compared to the pre-training assessment.
3 weeks
Secondary Outcomes (9)
Working memory performance at follow-up assessment
4 weeks after training
Working memory training performance (Letter Updating Task) at post-assessment
3 weeks
Working memory training performance (Letter Updating Task) at follow-up assessment
4 weeks after training
Quality of Life at post-assessment
3 weeks
Quality of Life at follow-up assessment
4 weeks after training
- +4 more secondary outcomes
Study Arms (3)
Anodal tDCS + cognitive training
EXPERIMENTALdevice: 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 COMPARATORdevice: 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 COMPARATORdevice: 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
Interventions
Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)
Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants
Intensive cognitive training of a letter memory updating task, 9 sessions
Standardized instructed PMR training, 9 sessions
Eligibility Criteria
You may qualify if:
- Self-reported concerns regarding cognitive functioning.
- Age: 18-60 years.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Medicine Greifswald
Greifswald, Germany
Related Publications (1)
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.
PMID: 35410927DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Agnes Flöel, Prof.
University Medicine Greifswald
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2021
First Posted
June 29, 2021
Study Start
January 5, 2022
Primary Completion
September 9, 2024
Study Completion
October 8, 2024
Last Updated
December 5, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
Anonymized data will be made available to the scientific community upon request.