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

Cognitive Impairment Clinical Trial

— CCTLongCOVID  

Official title:

Detailed Study on the Safety, Dosage and Feasibility of an Intervention Based on a Computerized Cognitive Training (CCT) for Individuals With Post-acute Sequelae of COVID-19 (PASC): A Phase I/II Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05582603
• Other study ID #: UNNE-2021-010
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 18, 2022
• Est. completion date: November 30, 2022

Study information

• Verified date: October 2022
• Source: Universidad Antonio de Nebrija
• Contact: Jon Andoni Duñabeitia, PhD
• Phone: 0034 900321322
• Email: jdunabeitia[@]nebrija.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• COVID-19

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Universidad Nebrija	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Antonio de Nebrija

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue Level Questionnaire	Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)	In Phase I, after each iteration of a 15-minute training.
Primary	Fatigue Level Questionnaire	Fatigue questionnaire adapted from the Brief Fatigue Inventory (Mendoza et al., 1999)	In Phase II, on even days (rest days of the intervention protocol).
Primary	Safety Level Questionnaire	Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.	In Phase I, after each iteration of a 15-minute training.
Primary	Safety Level Questionnaire	Safety questionnaire aimed at exploring the existence of side effects and/or adverse events.	In Phase II, on even days (rest days of the intervention protocol).
Primary	Classification of side effect or adverse events	Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).	In Phase I, after each iteration of a 15-minute training, only in case side effects or adverse events have been reported in the Safety Questionnaire.
Primary	Classification of side effect or adverse events	Interview adapted from the Patient-Reported Adverse Drug Event Questionnaire (de Vries et al., 2013).	In Phase II, on even days (rest days of the intervention protocol), only in case side effects or adverse events have been reported in the Safety Questionnaire.
Secondary	Computerized Cognitive Assessment	Complete cognitive evaluation based on Cognitive Assessment Battery (CogniFit Inc., San Francisco, USA).	In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Secondary	Quality of Life Assessment	Short version of the self-perceived global physical and mental health scale from the Patient-Reported Outcomes Measurement Information System (PROMIS v.1.2).	In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Secondary	Paper-and-pencil Cognitive Assessment	The Montreal Cognitive Assessment (MoCA).	In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).