Safety and Dosage of a Computerized Cognitive Training Program for Cognitive Dysfunction After COVID-19

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

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2022-11-30

Brief Summary

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The goal of this Phase I/II clinical trial is to assess the safety and maximum tolerated training time of a self-administered computerized cognitive training (CCT) in individuals with cognitive dysfunction as a consequence of COVID-19 infection.

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Detailed Description

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A Phase I/II protocol is designed to determine the safety of a Computerized Cognitive Training (CCT) aimed at ameliorating the cognitive dysfunction often observed in persons with post-acute sequelae of COVID-19 (PASC). The Phase I/II trial also aims at establishing the maximum tolerated training time per session of the CCT and to explore the feasibility of such intervention. In Phase I, through a 3+3 design, a dose-escalation trial will be set. Participants will be tested across subsequent training blocks of 15 minutes each, reporting on the experienced fatigue or adverse effects after every block. The safe training dose will be set to a block before extreme fatigue or a notable adverse effect has been reported by two or more participants. Once a safety training time has been established, a group of participants will engage in a 15-day training effectiveness assessment. After an initial thorough pre-test assessment, the intervention protocol will start. An evaluation day and a training day will be interspersed so that participants will complete a total of 8 training sessions (days 1, 3, 5, 7, 9, 11, 13 and 15). After the final day of intervention, a post-test assessment session will be carried out.

Conditions

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Post-Acute COVID-19 Post Acute COVID-19 Syndrome Cognitive Dysfunction Cognitive Impairment

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Phase I: An open-label prospective Phase I dose-escalation study following a standard 3+3 rule-based up-and-down design without dose de-escalation will be followed.

Phase II: An open-label prospective clinical trial to validate the minimum dosage and appropriate safety using the training time obtained in Phase I for the CCT along a 15-day training period with a 24-hour rest between sessions.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Computerized Cognitive Training

Individuals enrolled in Phase I and II will complete a Computerized Cognitive Training (CCT) based on an intervention with 15 different cognitive tasks in the form of games aimed at enhancing memory, attention, reasoning, perception and coordination skills. The CCT will be implemented in an app designed by CogniFit (CogniFit Inc., San Francisco, USA) to be used in tablets or mobile phones.

Group Type EXPERIMENTAL

CCT Long COVID

Intervention Type BEHAVIORAL

A 15-day training protocol in which every 48 hours participants' complete a series of different cognitive tasks in the form of games selected among a pool of 12 games from CogniFit (CogniFit Inc., San Francisco, USA) whose difficulty level is tailored to each individual by the a patented Individualized Training System™ (ITS) software that automatically chooses the activities and difficulty levels for each person in every session.

Interventions

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CCT Long COVID

A 15-day training protocol in which every 48 hours participants' complete a series of different cognitive tasks in the form of games selected among a pool of 12 games from CogniFit (CogniFit Inc., San Francisco, USA) whose difficulty level is tailored to each individual by the a patented Individualized Training System™ (ITS) software that automatically chooses the activities and difficulty levels for each person in every session.

Intervention Type BEHAVIORAL

Other Intervention Names

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CogniFit CCT Long COVID

Eligibility Criteria

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Inclusion Criteria

* Adults between 25 and 55 years old.
* History of infection with COVID-19 at least 3 months prior to expression of interest with a valid diagnostic or antibody test.
* Presence of self-perceived cognitive dysfunction associated with post-acute sequelae of COVID-19 (concentration problems or brain fog).

Exclusion Criteria

* Suicidal traits.
* Poor digital skills.
* Not having access to a mobile phone or tablet with Internet connection during the time of the intervention (only for Phase II).
* Not having 60 spare minutes per day to complete the intervention (only for Phase II).

Minimum Eligible Age

25 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes