N/A
N=1
Reanimation in Tetraplegia
Spinal Cord Injury (Quadraplegia)
Bottom Line
View on ClinicalTrials.gov: NCT01997125 ↗Enrolled (actual)
1
Serious AEs
100.0%
Results posted
Jul 2021
Primary outcome: Primary: Number of Participants With Voluntary Movement — 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neural Bridge System (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Marcia Bockbrader
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Voluntary Movement |
1; 0 | — |
Summary
The purpose of this clinical study is to allow the investigation of the Neural Bridging System for participants with tetraplegia to assess if the investigational device can reanimate a paralyzed limb under voluntary control by the participant's thoughts.
Eligibility Criteria
Inclusion Criteria
- Must be 21 years or older.
- Must be tetraplegic (C4- C6 ASIA A).
- 12 months post injury and neurologically stable.
- Participant is willing to comply with all follow-up evaluations at the specified times.
- Participant is able to provide informed consent prior to enrollment in the study.
- The participant is fluent in English.
- Participant must have a caregiver willing to participate in the study who will provide care for the surgical site.
Exclusion Criteria
- No active wound healing or skin breakdown issues.
- No history of poorly controlled autonomic dysreflexia.
- Medical contraindications for general anesthesia, craniotomy, or surgery.
- Diagnosis of acute myocardial infarction or cardiac arrest within previous 6 months.
- Participants with any type of destruction and/or damage to the motor cortex region as determined by MRI.
- History of psychiatric disturbance or dementia
- Other implantable devices such as heart/brain pacemakers
- Participants who rely on ventilators
- Co-morbid conditions that would interfere with study activities or response to treatment.
- History of a neurological ablation procedure.
- Labeled contraindication for MRI.
- History of hemorrhagic stroke.
- History of HIV infection or ongoing chronic infection (such as tuberculosis).
- Pregnant or of child-bearing potential and are not taking acceptable methods of contraception.
- Participation in another FDA device or medication trial that would interfere with the current study.
Data sourced from ClinicalTrials.gov (NCT01997125). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.