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Cognitive Training and Brain Stimulation in Patients With Post-COVID-19 Cognitive Impairment

NCT ID: NCT04944147

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2024-10-08

Brief Summary

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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

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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

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COVID-19 Post-COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Anodal tDCS + cognitive training

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

Group Type EXPERIMENTAL

Anodal tDCS

Intervention Type DEVICE

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)

Intensive cognitive training

Intervention Type BEHAVIORAL

Intensive cognitive training of a letter memory updating task, 9 sessions

Sham tDCS + cognitive training

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

Group Type PLACEBO_COMPARATOR

Sham tDCS

Intervention Type DEVICE

Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants

Intensive cognitive training

Intervention Type BEHAVIORAL

Intensive cognitive training of a letter memory updating task, 9 sessions

Sham tDCS + Progressive Muscle Relaxation training

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

Group Type ACTIVE_COMPARATOR

Sham tDCS

Intervention Type DEVICE

Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants

Progressive muscle relaxation (PMR)

Intervention Type BEHAVIORAL

Standardized instructed PMR training, 9 sessions

Interventions

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Anodal tDCS

Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)

Intervention Type DEVICE

Sham tDCS

Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants

Intervention Type DEVICE

Intensive cognitive training

Intensive cognitive training of a letter memory updating task, 9 sessions

Intervention Type BEHAVIORAL

Progressive muscle relaxation (PMR)

Standardized instructed PMR training, 9 sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. History of COVID-19 condition at least 4-6 weeks prior to study inclusion
2. Self-reported concerns regarding cognitive functioning.
3. Age: 18-60 years.

Exclusion Criteria

1. Acute COVID-19 illness.
2. History of dementia before COVID-19.
3. Other neurodegenerative neurological disorders; epilepsy or history of seizures.
4. Severe and untreated medical conditions that preclude participation in the training, as determined by responsible physician.
5. History of severe alcoholism or use of drugs.
6. Severe psychiatric disorders such as severe depression (if not in remission) or psychosis.
7. Contraindication to tDCS application (Antal et al. 2017).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medicine Greifswald

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Agnes Flöel, Prof.

Role: STUDY_DIRECTOR

University Medicine Greifswald

Locations

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University Medicine Greifswald

Greifswald, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 35410927 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Neuromod-COV

Identifier Type: -

Identifier Source: org_study_id