ALSBRAVONCT03698149
ECoG BMI for Motor and Speech Control
A study testing PMT/Blackrock Combination Device in people with ALS and SCI - Spinal Cord Injury, run by Karunesh Ganguly at 1 site in United States.
Trial summary
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- ALS, SCI - Spinal Cord Injury, Stroke
- What is being tested?
- PMT/Blackrock Combination Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2018to 15 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age \> 21
- Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy.
- Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living.
- If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms
- Must live within a two-hour drive of UCSF
Who cannot join
- Pregnancy or breastfeeding
- Inability to understand and/or read English
- Inability to give consent
- Dementia, based on history, physical exam, and MMSE
- Active depression (BDI \> 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.)
- History of suicide attempt or suicidal ideation
Show all 17Show fewer
- History of substance abuse
- Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure
- Inability to comply with study follow-up visits
- Any prior intracranial surgery
- History of seizures
- Immunocompromised
- Has an active infection
- Has a CSF drainage system or an active CSF leak
- Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition
- Has an implanted electronic device such as a neurostimulator, cardiac pacemaker/defibrillator or medication pump, or presence of any head or neck metallic foreign bodies
- Allergies or known hypersensitivity to materials in the Blackrock NeuroPort Array (i.e. silicone, titanium) or the PMT Subdural Cortical Electrode (silicone, platinum iridium, nichrome)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Adelyn Tu-Chan, (415) 575-0431, adelyn.tu@ucsf.edu
About this study
Official title: A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.
Read the detailed description
ECoG is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. With this ECoG-based neural interface, study patients will undergo training and assessment of their ability to control a complex robotic system and to determine if ECoG brain signals can be used to produce speech.
- Conditions
- ALS, SCI - Spinal Cord Injury, Stroke, Multiple Sclerosis, Muscular Dystrophies
- Being tested
- PMT/Blackrock Combination Device
- Medical subject headings
- Spinal Cord Injuries, Stroke, Multiple Sclerosis, Muscular Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMT/Blackrock Combination DeviceDevice
PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
| Study group | Role | What they receive |
|---|---|---|
| Electrocorticography-based brain computer interface | Experimental | Not described Receives: Device: PMT/Blackrock Combination Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The primary endpoint of this study is to determine the incidence of treatment-emergent adverse events associated with the ECoG-based interface
Measured: Up to 6 years post-implant period
NIDCD Primary Objective 1
To enable communication via text decoded from neural signals.
Measured: Up to 6 years post-implant period
NIDCD Primary Objective 2
To enable communication via synthesized speech decoded from neural signals.
Measured: Up to 6 years post-implant period
Secondary outcomes (2)
NIDCD Secondary Objective 1
To evaluate communication via text decoded from neural signals.
Measured: Up to 6 years post-implant period
NIDCD Secondary Objective 2
To evaluate communication via synthesized speech decoded from neural signals.
Measured: Up to 6 years post-implant period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start9 Nov 2018
- Primary completion15 Aug 2030 (estimated)
- Study completion15 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ALSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karunesh Ganguly
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor-investigator, Karunesh Ganguly, University of California, San Francisco
- Investigators
- Karunesh Ganguly, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698149
- Sponsor's protocol ID
- 17-23028
- Other IDs
- U01DC018671
- Acronym
- BRAVO
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2018
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Silva AB, Liu JR, Anderson VR, Kurtz-Miott CM, Hallinan IP, Littlejohn KT, Brosler SC, Tu-Chan A, Ganguly K, Moses DA, Chang EF. Implications of shared motor and perceptual activations on the sensorimotor cortex for neuroprosthetic decoding. J Neural Eng. 2025 Aug 7;22(4):046039. doi: 10.1088/1741-2552/adf50e.
PubMed 40720979Shah AM. Unlocking Naturalistic Speech With Brain-Computer Interface. Artif Organs. 2025 Jul;49(7):1087-1088. doi: 10.1111/aor.15021. Epub 2025 May 12.
PubMed 40353311Silva AB, Liu JR, Anderson VR, Kurtz-Miott CM, Hallinan IP, Littlejohn KT, Brosler S, Tu-Chan A, Ganguly K, Moses DA, Chang EF. Implications of shared motor and perceptual activations on the sensorimotor cortex for neuroprosthetic decoding. medRxiv [Preprint]. 2025 Apr 28:2025.04.24.25326368. doi: 10.1101/2025.04.24.25326368.
PubMed 40343020Metzger SL, Liu JR, Moses DA, Dougherty ME, Seaton MP, Littlejohn KT, Chartier J, Anumanchipalli GK, Tu-Chan A, Ganguly K, Chang EF. Generalizable spelling using a speech neuroprosthesis in an individual with severe limb and vocal paralysis. Nat Commun. 2022 Nov 8;13(1):6510. doi: 10.1038/s41467-022-33611-3.
PubMed 36347863Moses DA, Metzger SL, Liu JR, Anumanchipalli GK, Makin JG, Sun PF, Chartier J, Dougherty ME, Liu PM, Abrams GM, Tu-Chan A, Ganguly K, Chang EF. Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria. N Engl J Med. 2021 Jul 15;385(3):217-227. doi: 10.1056/NEJMoa2027540.
PubMed 34260835
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A High-Performance ECoG-based Neural Interface for Communication and Neuroprosthetic Control
- ClinicalTrials.gov ID
- NCT03698149
- Acronym / sponsor ID
- BRAVO / 17-23028
- Conditions
- ALS, SCI - Spinal Cord Injury, Stroke, Multiple Sclerosis, Muscular Dystrophies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Karunesh GangulyUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 15 Aug 2030 (estimated)
- Study completion
- 15 Aug 2030 (estimated)
- First posted
- 5 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Test the feasibility of using electrocorticography (ECoG) signals to control complex devices for motor and speech control in adults severely affected by neurological disorders.
Detailed description
ECoG is a type of electrophysiological monitoring that uses electrodes placed directly on the exposed surface of the brain to record electrical activity. With this ECoG-based neural interface, study patients will undergo training and assessment of their ability to control a complex robotic system and to determine if ECoG brain signals can be used to produce speech.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrocorticography-based brain computer interface | Experimental | Device: PMT/Blackrock Combination Device |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age \> 21
- Limited ability to use upper limbs, based on neurological examination, due to stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis, cervical spinal cord injury, brainstem stroke, muscular dystrophy, myopathy or severe neuropathy.
- Disability, defined by a 4 or greater score on the Modified Rankin Scale, must be severe enough to cause loss of independence and inability to perform activities of daily living.
- If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms
- Must live within a two-hour drive of UCSF
Key exclusion criteria (17 listed)
- Pregnancy or breastfeeding
- Inability to understand and/or read English
- Inability to give consent
- Dementia, based on history, physical exam, and MMSE
- Active depression (BDI \> 20) or other psychiatric illness (active general anxiety disorder, schizophrenia, bipolar disorder, obsessive-compulsive disorder (OCD), or personality disorders (e.g. multiple personality disorder, borderline personality disorder, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PMT/Blackrock Combination DevicePMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System | Device | Electrocorticography-based brain computer interface |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Up to 6 years post-implant period
The primary endpoint of this study is to determine the incidence of treatment-emergent adverse events associated with the ECoG-based interface
NIDCD Primary Objective 1
Time frame: Up to 6 years post-implant period
To enable communication via text decoded from neural signals.
NIDCD Primary Objective 2
Time frame: Up to 6 years post-implant period
To enable communication via synthesized speech decoded from neural signals.
2 secondary outcomes
NIDCD Secondary Objective 1
Time frame: Up to 6 years post-implant period
NIDCD Secondary Objective 2
Time frame: Up to 6 years post-implant period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Derived from this study: PubMed 40720979Silva AB, Liu JR, Anderson VR, Kurtz-Miott CM, Hallinan IP, Littlejohn KT, Brosler SC, Tu-Chan A, Ganguly K, Moses DA, Chang EF. Implications of shared motor and perceptual activations on the sensorimotor cortex for neuroprosthetic decoding. J Neural Eng. 2025 Aug 7;22(4):046039. doi: 10.1088/1741-2552/adf50e.
- Derived from this study: PubMed 40353311Shah AM. Unlocking Naturalistic Speech With Brain-Computer Interface. Artif Organs. 2025 Jul;49(7):1087-1088. doi: 10.1111/aor.15021. Epub 2025 May 12.
- Derived from this study: PubMed 40343020Silva AB, Liu JR, Anderson VR, Kurtz-Miott CM, Hallinan IP, Littlejohn KT, Brosler S, Tu-Chan A, Ganguly K, Moses DA, Chang EF. Implications of shared motor and perceptual activations on the sensorimotor cortex for neuroprosthetic decoding. medRxiv [Preprint]. 2025 Apr 28:2025.04.24.25326368. doi: 10.1101/2025.04.24.25326368.
- Derived from this study: PubMed 36347863Metzger SL, Liu JR, Moses DA, Dougherty ME, Seaton MP, Littlejohn KT, Chartier J, Anumanchipalli GK, Tu-Chan A, Ganguly K, Chang EF. Generalizable spelling using a speech neuroprosthesis in an individual with severe limb and vocal paralysis. Nat Commun. 2022 Nov 8;13(1):6510. doi: 10.1038/s41467-022-33611-3.
- Derived from this study: PubMed 34260835Moses DA, Metzger SL, Liu JR, Anumanchipalli GK, Makin JG, Sun PF, Chartier J, Dougherty ME, Liu PM, Abrams GM, Tu-Chan A, Ganguly K, Chang EF. Neuroprosthesis for Decoding Speech in a Paralyzed Person with Anarthria. N Engl J Med. 2021 Jul 15;385(3):217-227. doi: 10.1056/NEJMoa2027540.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karunesh Ganguly, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PMT/Blackrock Combination Device in people with ALS and SCI - Spinal Cord Injury, run by Karunesh Ganguly at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adelyn Tu-Chan ((415) 575-0431, adelyn.tu@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: Up to 6 years post-implant period). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03698149, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.