NCT03698149

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
52mo left

Started Nov 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Nov 2018Aug 2030

First Submitted

Initial submission to the registry

August 21, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 5, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

November 9, 2018

Completed
11.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2030

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

11.8 years

First QC Date

August 21, 2018

Last Update Submit

April 30, 2026

Conditions

ALSSCI - Spinal Cord InjuryStrokeMultiple SclerosisMuscular Dystrophies

Outcome Measures

Primary Outcomes (3)

  • 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

    Up to 6 years post-implant period

  • NIDCD Primary Objective 1

    To enable communication via text decoded from neural signals.

    Up to 6 years post-implant period

  • NIDCD Primary Objective 2

    To enable communication via synthesized speech decoded from neural signals.

    Up to 6 years post-implant period

Secondary Outcomes (2)

  • NIDCD Secondary Objective 1

    Up to 6 years post-implant period

  • NIDCD Secondary Objective 2

    Up to 6 years post-implant period

Study Arms (1)

Electrocorticography-based brain computer interface

EXPERIMENTAL
Device: PMT/Blackrock Combination Device

Interventions

PMT/Blackrock Combination DeviceDEVICE

PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Electrocorticography-based brain computer interface

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 40720979DERIVED

  • Shah 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.

    PMID: 40353311DERIVED

  • Silva 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.

    PMID: 40343020DERIVED

  • Metzger 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.

    PMID: 36347863DERIVED

  • Moses 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.

    PMID: 34260835DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesStrokeMultiple SclerosisMuscular Dystrophies

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersBrain DiseasesVascular DiseasesCardiovascular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Karunesh Ganguly, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Adelyn Tu-Chan

CONTACT

(415) 575-0431adelyn.tu@ucsf.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 21, 2018

First Posted

October 5, 2018

Study Start

November 9, 2018

Primary Completion (Estimated)

August 15, 2030

Study Completion (Estimated)

August 15, 2030

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)