| NCT ID | NCT03698149 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karunesh Ganguly |
| Condition | ALS |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2018-11-09 |
| Primary Completion | 2030-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3 participants in total. It began in 2018-11-09 with a primary completion date of 2030-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Karunesh Ganguly, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT03698149 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, studying ALS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03698149 currently recruiting?
Yes, NCT03698149 is actively recruiting participants. Contact the research team at adelyn.tu@ucsf.edu for enrollment information.
Where is the NCT03698149 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT03698149 clinical trial?
NCT03698149 is sponsored by Karunesh Ganguly. The principal investigator is Karunesh Ganguly, MD, PhD at University of California, San Francisco. The trial plans to enroll 3 participants.
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