Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve
NCT06279325, Not applicable, Recruiting, Universidad de Zaragoza
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effects of a Computerized Cognitive Stimulation Intervention Adapted to the Level of Cognitive Reserve | ClinicalTrials.gov |
| NCT number | NCT06279325 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Universidad de Zaragoza | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Cognitive Dysfunction | ClinicalTrials.gov |
| Interventions | Computerized cognitive stimulation program, Face-to-face training-explanatory session | ClinicalTrials.gov |
| First posted | 2024-02-28 | ClinicalTrials.gov |
| Last updated | 2024-12-12 | ClinicalTrials.gov |
Registered outcomes 7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | MEC-35 (Spanish version of Folstein's Mini-Mental) | An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out. | The primary outcome variable is MEC-35 (Spanish version of Folstein's Mini-Mental): the most widely used cognitive test in Primary Care, adapted by Lobo to the Spanish population (Lobo, A., et al 1979). It evaluates 8 components: temporal orientation, spatial orientation, fixation memory, attention, calculation, short-term memory, language and praxis. Its sensitivity is 85-90% and its specificity 69% (Lobo, A. et al 1999). Although its cut-off point for detecting cognitive impairment is 24, in NC, scores between 28-35 points are considered (Friedman et al., 2012; Vinyoles Bargalló et al., 2002). | ClinicalTrials.gov |
| Primary | Cognitive Reserve Questionnaire (CRQ) | An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out. | To determine the level of cognitive reserve (Landenberger et al., 2019) the most suitable questionnaire is the Cognitive Reserve Questionnaire (CRQ) (Rami et al., 2011). It has eight items with between three and six response options. Each item relieves a CR factor: schooling, parental schooling, courses, occupation, musical training, languages, reading and intellectual games. The maximum score is 25 points. Between 7 and 9 points is considered a medium-low range of CR. Between 10-14 points medium-high range, and ≥15 points, high CR. It is an instrument with high reliability and acceptable convergent validity (Martino et al., 2021). | ClinicalTrials.gov |
| Secondary | Set-Test | An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out. | -Set-Test (Pascual, L., Martinez, J., Modrego, P., Mostacero, E., Lopez del Val, J., \& Morales, 1990): measures verbal fluency of categorical type: colors, animals, fruits and cities, asking the patient to say elements of the 4 categories in one minute. It presents a sensitivity of 87% and a specificity of 67%. | ClinicalTrials.gov |
| Secondary | The SDMT or Symbols and Digits Test | An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out. | The SDMT or Symbols and Digits Test measures EF, processing speed and attention. It is a test with good accuracy, sensitivity and specificity, useful for predicting future MCI. The SDMT card consists of a header with a key that relates the numbers from 1 to 9 with different symbols; the participant has 90 seconds to match a specific number with a particular geometric figure. The response can be written or verbal, and the maximum total response time is five minutes. The ideal cut-off point is 44 points, although 38 points can be used for a more specific result (Baudouin et al., 2009). | ClinicalTrials.gov |
| Secondary | Color Word Stroop Test (CWST) | An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out. | Color Word Stroop Test (CWST) (Cheng et al., 2012) assesses perseveration, cognitive flexibility, EF and attention (Uttl \& Graf, 1997). It consists of naming a color with and without the presence of conflicting or incongruent stimuli. The test consists of three sheets: in the first one, colors written in black ink are repeated, in the second one colors with their geometric figure, and in the third one colors written in different ink. The correct answers in the three sheets are collected. This test shows a decrease by age and gender (the most impaired EF in men) (Periáñez et al., 2021; Van der Elst et al., 2008). The limits considered normal are 35-65 points (Graf et al., 1995). | ClinicalTrials.gov |
| Secondary | Verbal Learning Test (TAVEC) | An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out. | Verbal Learning Test (TAVEC) Spanish version of the California Verbal Learning Test (CVLT). It evaluates learning and episodic memory capacity. The test consists of memorizing a list of 16 words (list A), belonging to four semantic categories, and their subsequent recall. Five trials are repeated and a second list of 16 words (list B) is administered. Subsequently, recall of list A and recall by semantic categories is requested. After about 20 minutes, free recall of word list A and recall by semantic categories is requested again. Both Spearman's coefficient and Cronbach's α indicate high reliability (Nieto Barco et al., 2014). | ClinicalTrials.gov |
| Secondary | Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16) | An initial evaluation (pre), post-intervention (in a period of 2 to 7 days after the last intervention session) and two follow-up evaluations (at 6 and 12 months) will be carried out. | Mobile Device Proficiency Questionnaire in Short Form (MDPQ-16). Tests experience and aptitude for using mobile devices in eight domains: mobile device basics, communication, data and file storage, Internet, calendar, entertainment, privacy, troubleshooting, and software management. Each of the domains is scored on a 5-point scale (e.g., 1 = never tried , 2 = not at all , 3 = not very easily , 4 = somewhat easily , 5 = very easily). The total score ranges from 8 to 40, with higher scores reflecting greater competence. Internal consistency is excellent (Cronbach's α=.96).(Roque \& Boot, 2018). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 2
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)