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REstoration of Communication and LAnguage With Intracortical Microelectrodes

NCT07933549, Not applicable, Not yet recruiting, The University of Texas Health Science Center, Houston

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleREstoration of Communication and LAnguage With Intracortical MicroelectrodesClinicalTrials.gov
NCT numberNCT07933549ClinicalTrials.gov
StatusNot yet recruitingClinicalTrials.gov
PhasesNot applicableClinicalTrials.gov
Enrollment4 participants, estimatedClinicalTrials.gov
Lead sponsorThe University of Texas Health Science Center, HoustonClinicalTrials.gov
ConditionsAmyotrophic Lateral Sclerosis (ALS), locked-in Syndrome, Brain Injury, StrokeClinicalTrials.gov
InterventionsRECLAIM SystemClinicalTrials.gov
First posted2026-11-12ClinicalTrials.gov
Last updated2026-11-12ClinicalTrials.gov

Registered outcomes 7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimarySafety as assessed by the number and type of adverse events that occurFrom time of implant to one year post-implantClinicalTrials.gov
SecondarySafety as assessed by the number of participants with device explantedFrom time of implant to one year post-implantClinicalTrials.gov
SecondarySafety as assessed by the number of participants with Serious Adverse Events that result in death or permanently increased disabilityFrom time of implant to one year post-implantClinicalTrials.gov
SecondaryEffectiveness of the device as assessed by the Word error rate (WER)Every three months for the first two years post-implantClinicalTrials.gov
SecondaryEffectiveness of device as assessed by the Phoneme error rate (PER)Every three months for the first two years post-implantClinicalTrials.gov
SecondaryEffectiveness of the device as assessed by the Bilingual Evaluation Understudy (BLEU) ScoreEvery three months for the first two years post-implant
BLEU (Bilingual Evaluation Understudy) quantifies, on a range of 0-1, the overlap between the decoded text and the reference text based on matching n-grams. Higher BLEU scores indicate that the decoded output more closely matches the reference at the level of local word sequences.
ClinicalTrials.gov
SecondaryEffectiveness of the device as assessed by the Bidirectional Encoder Representations from Transformers (BERT) ScoreEvery three months for the first two years post-implant
BERT Score compares the semantic similarity (on a range of -1 to 1) between the decoded text sequence and the reference text using a pretrained language model (BERT). Higher scores indicated stronger semantic alignment.
ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

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)