An interventional study of RECLAIM System in Amyotrophic Lateral Sclerosis (ALS), locked-in Syndrome and Brain Injury, sponsored by The University of Texas Health Science Center, Houston. Not yet recruiting at 1 site in United States. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Other
Among 440 studies in Amyotrophic Lateral Sclerosis with a site in United States — 98 open to participants now, 129 under way, 11 of them phase 3. Amyotrophic Lateral Sclerosis · United States.
Among the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States, this one is the 279th largest by planned enrollment of the 307 interventional ones that give a count, is one of 34 that started in 2026, is one of 82 with no phase, reaches primary completion later than 117 of the 128 other live ones, and was the 440th registered.
978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.
Browse Amyotrophic Lateral Sclerosis studies →98 of the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Ages 18–80
Cognixion · Sites in United States
Ages 18+
Johns Hopkins University · Sites in United States
Ages 18+ · Healthy volunteers
Neuralink Corp · Sites in United States
Ages 18+
Biogen · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 192 Amyotrophic Lateral Sclerosis studies recruiting now, 117 (61%) set no upper age limit and 23 (12%) stop at 75 or younger; 15 take children under 18; 55 take healthy volunteers.
This study: 22 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
440 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 89 · Phase 2 139 · Phase 3 48 · Phase 4 1
First in 1982; this study’s year is marked. 34 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 4 is below the median of 38 across 662 interventional studies indexed under Amyotrophic Lateral Sclerosis.
Median enrollment 33 across the 307 interventional studies, 100 across the 121 observational. Of the 277 that completed or were terminated, 102 (37%) have results posted.
This tab as a report to print or save as PDF → With an account.
163 of 440 have an industry lead sponsor. The 10 most frequent:
The University of Texas Health Science Center, Houston is the lead sponsor of 899 studies on the registry; 215 are open to participants now.
Of its 174 completed or terminated interventional studies of FDA-regulated products, 142 (82%) have results posted.
The University of Texas Health Science Center, Houston has 1 study filed under Amyotrophic Lateral Sclerosis — fewer than ten, so there is no comparison to draw.
41 of the studies in Amyotrophic Lateral Sclerosis with a site in United States that are under way reach primary completion within a year, 6 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07161999Phase 3Coya TherapeuticsStudy of COYA 302 for the Treatment of ALS | 2027-04 |
| NCT04057898Phase 3MediciNovaEvaluation of MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients With ALS | 2027-04 |
| NCT04297683Phase 3Merit E. Cudkowicz, MDHEALEY ALS Platform Trial - Master Protocol | 2027-07 |
| NCT07410806Phase 3Merit E. Cudkowicz, MDHEALEY ALS Platform Trial - Regimen I NUZ-001 | 2027-07-01 |
| NCT04220190Phase 3Rapa Therapeutics LLCRAPA-501 Therapy for ALS | 2027-07-01 |
Add all 41 to your calendar (.ics) → With an account.
Among the 440 studies in Amyotrophic Lateral Sclerosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of ALS, locked-in syndrome, or stroke
Minimal communication ability as assessed by a speech-language pathologist
Limited upper limb strength based on the Medical Research Council Scale for Muscle Strength
i. For patients with 4/5 strength, they must have a documented decline in speech or upper extremity function in the preceding 12 months.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Safety as assessed by the number and type of adverse events that occur
Time frame: From time of implant to one year post-implant
Safety as assessed by the number of participants with device explanted
Time frame: 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
Effectiveness of the device as assessed by the Word error rate (WER)
Time frame: 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
Effectiveness of the device as assessed by the Bilingual Evaluation Understudy (BLEU) Score
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.
Time frame: 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
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.
Time frame: Every three months for the first two years post-implant
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2035, 98 months later.
Of 134 non-industry interventional studies with no phase under Amyotrophic Lateral Sclerosis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 60. This study's planned 98 months is above that.
Counting every sponsor, half of 154 studies reached it within 35 months; a quarter within 23 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Amyotrophic Lateral Sclerosis →
The University of Texas Health Science Center, Houston →