NCT05571852

Brief Summary

This before-and-after study aims to evaluate the usefulness and efficacy of a personalized computerized cognitive training (CCT) to improve cognitive function among people with post-acute sequelae of COVID-19 (PASC).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

October 3, 2022

Last Update Submit

October 5, 2022

Conditions

Keywords

Long COVIDComputerized Cognitive TrainingPost-Acute Sequeale of COVID-19Cognitive DysfunctionBrain Fog

Outcome Measures

Primary Outcomes (1)

  • Cognitive Gains

    The difference in scores between the initial and final assessments as evaluated by the Cognitive Assessment Battery (CAB)™ PRO

    8 weeks

Secondary Outcomes (1)

  • Intensity of the training

    8 weeks

Study Arms (1)

Computerized Cognitive Training

EXPERIMENTAL

Participants will be asked to complete short sessions of around 10 minutes each consisting of a variety of games designed to train the five cognitive skills (attention, memory, coordination, reasoning and perception). Each training session include two games selected among a pool of 12 different games. Participants will be asked to complete a training lasting for 8 weeks in which they could access the training platform as frequently as they wanted.

Device: CogniFit's CCT Post COVID-19

Interventions

The computerized cognitive training (CCT) program is tailored to each person's specific cognitive strengths and weaknesses detected in the Cognitive Assessment Battery (CAB)™ PRO (CogniFit Inc., San Francisco, US; https://www.cognifit.com/cab) by a patented Individualized Training System™ (ITS) software.

Computerized Cognitive Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (older than 18 years old).
  • History of infection with COVID-19 at least 3 months prior to expression of interest.
  • Presence of self-perceived cognitive dysfunction associated with PACS (concentration problems or brain fog).

You may not qualify if:

  • Completion of less than 10 training sessions.
  • Not completing the final evaluation after the 8-week training period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Nebrija

Madrid, Spain

Location

Related Publications (1)

  • Dunabeitia JA, Mera F, Baro O, Jadad-Garcia T, Jadad AR. Personalized Computerized Training for Cognitive Dysfunction after COVID-19: A Before-and-After Feasibility Pilot Study. Int J Environ Res Public Health. 2023 Feb 10;20(4):3100. doi: 10.3390/ijerph20043100.

MeSH Terms

Conditions

Post-Acute COVID-19 SyndromeCognitive DysfunctionMental Fatigue

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition DisordersNeurocognitive DisordersMental DisordersFatigueSigns and SymptomsBehavioral SymptomsBehavior

Study Officials

  • Jon Andoni Duñabeitia

    Universidad Nebrija

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 7, 2022

Study Start

December 1, 2021

Primary Completion

February 28, 2022

Study Completion

February 28, 2022

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations