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

Universidad Antonio de Nebrija

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Post-Acute COVID-19; Cognitive Impairment; Cognitive Dysfunction; Post Acute COVID-19 Syndrome

Treatments: Behavioral: CCT Long COVID

Study type: Interventional

Funder types: Other

Identifiers

NCT05582603

UNNE-2021-010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 25 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Computerized Cognitive Training

Experimental group

Description:

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.

Treatment:

Behavioral: CCT Long COVID