Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01894802 : Cortical Recording and Stimulating Array Brain-Machine Interface
PhaseN/A
AgesMin: 22 Years Max: 70 Years
Eligibility
Inclusion Criteria:

1. Subjects must have limited or no ability to use both hands due to cervical spinal
cord injury, brainstem stroke or spinal stroke. Individuals with tetraplegia must
have less than grade 4 muscle strength in elbow extension and wrist extension and
less than grade 2 strength in finger flexor and abduction on the contralateral side
to the implant. We will include subjects with both complete and incomplete injuries.

2. Subjects must report that they are unable to perform functional activities with the
hand contralateral to implantation.

3. Subjects must be over 1 year post-injury at time of implantation. In addition,
subject must report no worsening in neurologic status (strength, sensation) for the
previous 6 months.

4. Subjects must be between the ages of 22-70 years old. Participants outside this age
range may be at an increased surgical risk and increased risk of fatigue during BMI
training.

5. Subjects must live within 1 hour of the University of Pittsburgh during the study or
be willing to travel to the University of Pittsburgh at least once per week for BMI
training.

6. If subjects do not live in the Pittsburgh area, they are expected to stay somewhere
within 1 hour of the University of Pittsburgh for at least 18 months after
enrollment.

7. Subjects must be able to communicate with the investigators in English because of the
need to follow the instructions of the study team.

8. Subjects must show an understanding of the study goals and have the ability to follow
simple directions as judged by the investigators

9. Subjects must have results that are within normal limits on neuropsychological and
psychosocial assessment; psychosocial health and support will be assessed by
interview with the psychologist.

10. Subjects must be able to activate distinct cortical areas during imagined or
attempted movement tasks (i.e. hand movement and speaking or moving the mouth); this
will be evaluated with functional magnetic resonance imaging (fMRI) as part of
screening.

11. Subjects must have a stable psychosocial support and caregivers who are able to
perform the necessary daily care of the participant's skin and pedestal site. This
requires that the subject identify a caregiver and a backup who have been in place
for greater than 6 months and are able to provide needed physical and psychosocial
support. This will be assessed by the sponsor-investigator and study neurosurgeon.

12. Subjects must have a life expectancy greater than 18 months as assessed by the study
investigator and neurosurgeon sub-investigator

13. Documentation of informed consent must be obtained from the participant or their
legal representative.

Exclusion Criteria:

1. Visual impairment such that extended viewing of a computer monitor would be difficult
even with ordinary corrective lenses

2. Another serious disease(s) or disorder(s) that could affect ability to participate in
this study (verified during pre-op anesthesia evaluation to determine surgical risk
status)

3. Recent history of pressure sores that could be exacerbated by 1-2 days of bed rest

4. Metallic implant(s) that would prohibit the subject from having an fMRI scan; spinal
fixators are generally non-ferrous and would not exclude someone from participating
in the study

5. Any type of implantable generator such as a pacemaker, spinal cord stimulator,
cochlear implant, deep brain stimulator (DBS), DBS leads, vagus nerve stimulator, or
defibrillator

6. Women of childbearing age who are pregnant, lactating, or plan to become pregnant
during the next 25 months

7. Allergy to contrast medium or kidney failure that could be exacerbated by contrast
agent (for MRI)

8. Subjects receiving medications (such as sedatives) chronically that may retard motor
coordination and cognitive ability

9. Individuals who require routine MRI, therapeutic ultrasound, or diathermy

10. Individuals with osteomyelitis

11. Severe skin disorder that causes excessive skin sloughing, lesions or breakdown of
the scalp

12. History of myocardial infarction or cardiac arrest or with intractable cardiac
arrhythmias

13. Individuals with an implanted hydrocephalus shunt

14. Individuals who have had a stroke caused by a surgical procedure

15. Active infection(s) or unexplained fever (verified during pre-op anesthesia
evaluation to determine surgical risk status)

16. Consumption of more than 1 alcoholic beverage per day on average

17. Receiving chronic oral or intravenous steroids or immunosuppressive therapy

18. Active cancer within the past year (other than adequately treated basal cell or
squamous cell skin cancer) or require chemotherapy

19. Uncontrolled insulin dependent diabetes mellitus

20. Uncontrolled autonomic dysreflexia within the past 3 months (for those with spinal
cord injury)

21. Individuals with seizure disorders currently being treated with anti-epileptic
medications and individuals with a familial history of seizure disorders

22. Individuals who have attempted suicide in the past 12 months

23. Individuals who are immunosuppressed or who have conditions that typically result in
immunocompromise (including, but not limited to: ataxia-telangiectasia, cancer,
Chediak-Higashi syndrome, combined immunodeficiency disease, complement deficiencies,
DiGeorge syndrome, HIV/AIDS, hypogammaglobulinemia, Job syndrome, leukocyte adhesion
defects, malnutrition, panhypogammaglobulinemia, Bruton disease, congenital
agammaglobulinemia, selective deficiency of IgA and Wiscott-Aldrich syndrome)

24. Individuals who have had previous neurosurgical intervention involving the frontal
lobes (especially the motor cortex) and/or parietal lobe (especially the
somatosensory cortex) that is likely to impact the viability of an intracortical
electrode

25. Individuals with active psychiatric concerns, including but not limited to major
depression, bipolar disorder, schizophrenia or other psychotic disorder and
post-traumatic stress disorder

26. Individuals with substance abuse within 6 months of study participation
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01894802      |      Link to official Clinicaltrials.gov listing
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