Recruiting

ECoG BMI

Sponsor:

Karunesh Ganguly

Code:

NCT03698149

Conditions

ALS

SCI - Spinal Cord Injury

Stroke

Multiple Sclerosis

Muscular Dystrophies

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

PMT/Blackrock Combination Device

Study Details

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.

Conditions

ALS

SCI - Spinal Cord Injury

Stroke

Multiple Sclerosis

Muscular Dystrophies

Study ID

NCT03698149

Start date

Nov 9, 2018

Status verified date

Apr, 2026

Completion date

Aug 15, 2030

Anticipated

Primary completion date

Aug 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age \> 21
2. 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.
3. 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.
4. If stroke or spinal cord injury, at least 1 year has passed since onset of symptoms
5. Must live within a two-hour drive of UCSF

Exclusion Criteria:

1. Pregnancy or breastfeeding
2. Inability to understand and/or read English
3. Inability to give consent
4. Dementia, based on history, physical exam, and MMSE
5. 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.)
6. History of suicide attempt or suicidal ideation
7. History of substance abuse
8. Co-morbidities including ongoing anticoagulation, uncontrolled hypertension, cancer, or major organ system failure
9. Inability to comply with study follow-up visits
10. Any prior intracranial surgery
11. History of seizures
12. Immunocompromised
13. Has an active infection
14. Has a CSF drainage system or an active CSF leak
15. Requires diathermy, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) to treat a chronic condition
16. 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
17. 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)

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Electrocorticography-based brain computer interface

Interventions

PMT/Blackrock Combination Device

PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: Up to 6 years post-implant period ]
  • NIDCD Primary Objective 1 [ Time Frame: Up to 6 years post-implant period ]
  • NIDCD Primary Objective 2 [ Time Frame: Up to 6 years post-implant period ]

Central Contacts and Locations

Central contacts

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94158

Contacts

More Information

Sponsor

Karunesh Ganguly

Last update posted

May 5, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Karunesh Ganguly on 2026-05-05.