Antibody-mediated LGI1 Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Chronic Phase of the Disease
NCT06515106, Not applicable, Recruiting, Fundacion Clinic per a la Recerca Biomédica
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Antibody-mediated LGI1 Encephalitis: Symptoms, Biomarkers, and Mechanisms of the Chronic Phase of the Disease | ClinicalTrials.gov |
| NCT number | NCT06515106 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 20 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Fundacion Clinic per a la Recerca Biomédica | ClinicalTrials.gov |
| Conditions | Limbic Encephalitis With LGI1 Antibodies | ClinicalTrials.gov |
| Interventions | Remote cognitive rehabilitation program | ClinicalTrials.gov |
| First posted | 2024-07-23 | ClinicalTrials.gov |
| Last updated | 2024-07-23 | ClinicalTrials.gov |
Registered outcomes 83
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Age | 12 months | Age measured in years | ClinicalTrials.gov |
| Primary | Gender | 12 months | Male or female | ClinicalTrials.gov |
| Primary | Handedness | 12 months | Right- or Left-handed | ClinicalTrials.gov |
| Primary | General medical history | 12 months | Description of the most important issues compiled in the general medical history of the participant | ClinicalTrials.gov |
| Primary | Allergies | 12 months | List of allergies of each participant | ClinicalTrials.gov |
| Primary | Symptoms related to anti-LGI1 encephalitis | 12 months | Detailed description of symptoms experienced before, during and after the post-acute phase of anti-LGI1 encephalitis. | ClinicalTrials.gov |
| Primary | Treatments | 12 months | All treatments in which the participant is being involved. | ClinicalTrials.gov |
| Primary | Functional status | 12 months | Functional status according to Modified Rankin Scale (mRS). Modified Rankin Scale: \- Range: from 0 points (no symptoms) to 6 points (dead). | ClinicalTrials.gov |
| Primary | Intelligence Quotient | 12 months | Estimated through General Ability Index (GAI; from Weschler Adult Intelligence Scale - IV (WAIS-IV). This index is obtained through Verbal Comprehension Index (VCI) and Perceptual Reasoning Index (PRI). Range of GAI: from 40 to 160. Higher is better. Range of VCI: from 50 to 150. Higher is better. Range of PRI: from 50 to 150. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Verbal working memory | 12 months | Verbal Working Memory: Working Memory Index (WMI) from WAIS-IV. \- Range of WMI: from 50 to 150. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Phonological loop | 12 months | Assessed by Forward order span of Digit span subtest from WAIS-IV. \- Range: from 0 to 9 Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Visual working memory | 12 months | Visual Working Memory: Spatial location subtest from Weschler Memory Scale - IV (WMS-IV). \- Range of Spatial Location subtest: from 0 to 32. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Verbal learning | 12 months | Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC \- Total learning: range: from 0 to 80. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Proactive interference verbal memory | 12 months | Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC). \- Interference list: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Short-term verbal memory | 12 months | Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC). \- Short-term memory free recall: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Long-term verbal memory | 12 months | Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC): \- Long-term memory free recall: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Verbal recognition memory | 12 months | Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC). \- Word-list Recognition: range: 0 to 15. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Verbal discrimination memory | 12 months | Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC) Discrimination index of word-list: False positives + omissions of recognition between 44 total words to recognize. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Verbal retention memory | 12 months | Assessed by: Adults: España - Complutense Auditory-Verbal Learning Test (Test de Aprendizaje Verbal España - Complutense; TAVEC); or Infants: España - Complutense Auditory-Verbal Learning Test for Children (Test de Aprendizaje Verbal España - Complutense Infantil; TAVECI) \- Retention index: percentatge of Long-term memory free recall between Short-term memory free recall. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | ClinicalTrials.gov |
| Primary | Immediate visual memory | 12 months | Assessed by: Brief Visuospatial Memory Test - Revised (BVMT-R) \- Immediate visual memory: range: from 0 to 36. Higher is better. Raw scores were transformed into standard T-scores (mean 50 ± standard deviation \[SD\] 10) and a score below 35 (≤ 1.5 SD below normative mean, or the equivalent ≤9th percentile) was considered significantly decreased. | 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 22
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 16278841 | BACKGROUND | PubMed |
| 20427647 | BACKGROUND | PubMed |
| 20580615 | BACKGROUND | PubMed |
| 20663977 | BACKGROUND | PubMed |
| 20952256 | BACKGROUND | PubMed |
| 22281844 | BACKGROUND | PubMed |
| 23290630 | BACKGROUND | PubMed |
| 24014519 | BACKGROUND | PubMed |
| 24227725 | BACKGROUND | PubMed |
| 25392198 | BACKGROUND | PubMed |
| 27466467 | BACKGROUND | PubMed |
| 27590293 | BACKGROUND | PubMed |
| 28298428 | BACKGROUND | PubMed |
| 28418022 | BACKGROUND | PubMed |
| 29490181 | BACKGROUND | PubMed |
| 30049614 | BACKGROUND | PubMed |
| 30346486 | BACKGROUND | PubMed |
| 30979857 | BACKGROUND | PubMed |
| 32437528 | BACKGROUND | PubMed |
| 35124649 | BACKGROUND | PubMed |
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 8
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 |
|---|---|---|
| Category Fluency | Primary outcome | ConductCognition |
| Digit Span Test | Primary outcome | ConductCognition |
| Picture Naming Test | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Symbol Scan Task | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Verbal Fluency | Primary outcome | ConductCognition |
| Verbal Learning | Primary 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)