Clinical trial NCT05582603: Safety and Dosage of a Computerized Cognitive Training Program for Cognitive Dysfunction After COVID-19
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Post-Acute COVID-19
Post Acute COVID-19 Syndrome
Cognitive Dysfunction
Cognitive Impairment
Keywords: post-acute sequelae of COVID-19
PASC
cognitive dysfunction
computerized cognitive training
brain training
Lead sponsor: Universidad Antonio de Nebrija
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Fatigue Level Questionnaire
timeFrame: In Phase I, after each iteration of a 15-minute training.
measure: Fatigue Level Questionnaire
timeFrame: In Phase II, on even days (rest days of the intervention protocol).
measure: Safety Level Questionnaire
timeFrame: In Phase I, after each iteration of a 15-minute training.
measure: Safety Level Questionnaire
timeFrame: In Phase II, on even days (rest days of the intervention protocol).
measure: Classification of side effect or adverse events
timeFrame: 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.
measure: Classification of side effect or adverse events
timeFrame: 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 outcomes:
measure: Computerized Cognitive Assessment
timeFrame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
measure: Quality of Life Assessment
timeFrame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
measure: Paper-and-pencil Cognitive Assessment
timeFrame: In Phase II, at pre-test (the day before the intervention protocol starts) and at post-test (the day after the intervention protocol finishes).
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Nebrija
Study officials:
affiliation: Universidad Nebrija
name: Jon Andoni Duñabeitia, PhD
role: PRINCIPAL_INVESTIGATOR
References: