REstoration of Communication and LAnguage With Intracortical Microelectrodes (RECLAIM)

November 5, 2026 updated by: Nitin Tandon, The University of Texas Health Science Center, Houston

Early Feasibility Study of the Restoration of Communication and Language With Intracortical Microelectrodes (RECLAIM) System

The purpose of this study is to investigate the safety and feasibility of using distributed intracortical recordings from the language network to decode intended language output in individuals with severe communication impairment due to severe communication impairment resulting from amyotrophic lateral sclerosis (ALS), locked-in syndrome, and brain injury including from stroke.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
        • Principal Investigator:
          • Nitin Tandon, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of ALS, locked-in syndrome, or stroke

    1. ALS - ALS patients who in the opinion of the treating neurologist have at least 3 years of survival
    2. Locked-in Syndrome as a result of brain-stem stroke or traumatic brain-stem injury - patients who in the opinion of the treating neurologist have at least 3 years of survival
    3. Stroke (either ischemic or hemorrhagic) - for patients with prior stroke, the original cause of the stroke (e.g., arteriovenous malformation, carotid stenosis, atrial fibrillation, heart disease, hypertension) must have been addressed and the patient must not have had a recurrent stroke at least within the prior 12 months

  • ALS diagnosis, stroke, or Locked-in syndrome (LIS) etiology onset occurred at least one year prior to enrollment

  • Minimal communication ability as assessed by a speech-language pathologist

    1. unable to produce more than 10 total unique intelligible words when reading the Rainbow Passage and Grandfather Passage, and
    2. unable to write or type more than 10 unique words from a dictated list of 20 words.

  • Limited upper limb strength based on the Medical Research Council Scale for Muscle Strength

    1. ≤3/5 strength throughout both arms for those with non-progressive conditions (stroke or traumatic brain-stem injury)
    2. ≤4/5 strength throughout both arms for those with ALS

    i. For patients with 4/5 strength, they must have a documented decline in speech or upper extremity function in the preceding 12 months.

  • Has a means of communication sufficient to enable understanding of research protocol and provide consent (e.g. eye blinks or eye movements, use of assistive technology). Thus patients are severely impaired with regards to naturalistic communication, but able to make decisions regarding their own care

  • Ability to understand and comply with study session instructions

  • Must live within a 90-minute drive of study site and willing to travel to study site up to three days per week for duration of the study

  • Has a stable psychosocial support system with caregiver capable of providing care during post-operative periods and monitoring participant throughout the study

  • Stable ventilator status - ventilator requirements have not changed over prior 6 months and ventilator status does not impose additional substantial risks to subject participation, including travel to the investigation site

Exclusion Criteria:

  • Psychiatric conditions including current diagnosis of major psychiatric illness, significant cognitive impairment (based on a neuropsychological assessment by a clinical psychologist), suicidal ideation with intent/plan. [Columbia-Suicide Severity Rating Scale (C-SSRS) Categories 4-5)] or suicidal behavior within 12 months, or substance abuse/narcotic/alcohol dependence within 12 months.
  • Neurological disorders including current diagnosis of epilepsy, abnormal pre-surgical neuroimaging precluding safe implant placement (per neurosurgical team), prior ipsilateral craniotomy, or hydrocephalus with or without ventricular shunt.
  • Implanted electronic devices including pacemakers, cardiac defibrillators, spinal cord stimulators, vagal nerve stimulators, deep brain stimulators, or cochlear implants.
  • Cardiovascular disorders including acute myocardial infarction (MI) or cardiac arrest within 6 months, significant cardiovascular impairment contraindicating surgery.
  • Hematological disorders requiring chronic anticoagulation and medical contraindication to discontinuing anticoagulant medications perioperatively.
  • Dermatological conditions causing excessive skin sloughing, poor wound healing, existing scalp lesions, or skin breakdown.
  • Infectious/immunological conditions including active infections, unexplained fever, HIV infection, ongoing chronic infections, medical conditions predisposing to high infection risk, chronic steroid or immunosuppressive therapy, or active cancer within 1 year requiring chemotherapy.
  • Medical contraindications including conditions contraindicating chronically implanted devices (osteomyelitis, diabetes, hepatic failure, autoimmune disease/disorders with associated altered immune responses) or other chronic unstable medical conditions interfering with participation.
  • Surgical contraindications including medical contraindications to general anesthesia, craniotomy, or surgery; significant pulmonary, metabolic, or renal impairments making surgical procedure unsafe.
  • Other exclusions including pregnancy (confirmed by blood test), nursing, inadequate contraception, correction vision worse than 20/100, limited English proficiency, or concurrent participation in device/drug trials.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: RECLAIM System
Device: RECLAIM System

6 microelectrode grids will be implanted within the dominant hemisphere, placed across key speech and language cortical regions. The device will be kept implanted for up to 5 years and study sessions will be conducted 3-5 times per week

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Safety as assessed by the number and type of adverse events that occur
Time Frame: From time of implant to one year post-implant
From time of implant to one year post-implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety as assessed by the number of participants with device explanted
Time Frame: From time of implant to one year post-implant
From time of implant to one year post-implant
Safety as assessed by the number of participants with Serious Adverse Events that result in death or permanently increased disability
Time Frame: From time of implant to one year post-implant
From time of implant to one year post-implant
Effectiveness of the device as assessed by the Word error rate (WER)
Time Frame: Every three months for the first two years post-implant
Every three months for the first two years post-implant
Effectiveness of device as assessed by the Phoneme error rate (PER)
Time Frame: Every three months for the first two years post-implant
Every three months for the first two years post-implant
Effectiveness of the device as assessed by the Bilingual Evaluation Understudy (BLEU) Score
Time Frame: Every 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.
Every three months for the first two years post-implant
Effectiveness of the device as assessed by the Bidirectional Encoder Representations from Transformers (BERT) Score
Time Frame: Every 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.
Every three months for the first two years post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center, Houston

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2039

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSC-MS-26-0020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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