BridgeMD
New treatment option for Tetraplegia/Tetraparesis
Official title Interfacing With NeuroTechnology to Expand Neural Throughput (INTENT)
ClinicalTrials.gov ID: NCT07521930
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the safety and preliminary efficacy of an implantable device that records and stimulates different areas of the brain to allow adults affected by disabling paralysis (see Eligibility for more details) to control and receive feedback from assistive devices.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs...
- Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke\ , traumatic spinal cord injury (SCI), or...
- Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an...
- Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor...
- Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\<3) throughout the...
You likely can't join if
- Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
- Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).
- Contraindications to MRI or anticipated need for an MRI during the study period
- Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments...
- Chronic anti-coagulation and medical contraindication to temporary suspension for surgery
- Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe...
See the full eligibility criteria
Who can join
- Complete or incomplete tetraplegia (quadriplegia), tetraparesis (quadriparesis), severe ataxia, or disabling motor impairments in both upper limbs, based on neurological exam. In addition, these motor impairments may be...
- Clinical diagnosis must be established for the etiology of motor impairments, including brainstem stroke\ , traumatic spinal cord injury (SCI), or progressive and irreversible neuromuscular disease, including muscular...
- Candidates with traumatic spinal cord injury must have a complete or incomplete tetraplegia or tetraparesis (ASIA Impairment Scale A, B, C) with an injury level of C6 or higher.
- Candidates with tetraplegia or tetraparesis from traumatic SCI and other non-progressive neurological disorders must have an upper extremity motor score (UEMS, ISNCSCI) of 7 or less in each of the upper extremities...
- Candidates with progressive conditions with shortened life expectancy, such as ALS, must have less than antigravity strength (\<3) throughout the upper limbs.
- Persistence of motor impairments at least 12 months prior to enrollment if due to a non-progressive neurological cause such as stroke or spinal cord injury
- Meeting surgical safety criteria, including surgical clearance by the participant's primary healthcare provider, study physicians, and any necessary consultants
- Ability to communicate reliably, such as through speech or eye movement
- Stable psychosocial support system with caregiver capable of monitoring participant throughout the study
- Ability and willingness to travel to study location up to five days per week for the duration of the study
- Ability to understand and comply with study session instructions
- Corrected visual acuity sufficient for use of computer monitor
What rules you out
- Psychiatric conditions or cognitive impairments that would interfere with obtaining informed consent or fully participating in study activities.
- Individuals with active implanted devices, including devices that are incompatible with magnetic resonance imaging (MRI).
- Contraindications to MRI or anticipated need for an MRI during the study period
- Medical conditions contraindicating device implantation surgery (for example significant pulmonary, cardiovascular, metabolic, or renal impairments making the surgical procedure unsafe)
- Chronic anti-coagulation and medical contraindication to temporary suspension for surgery
- Medical conditions contraindicating chronic device implantation (e.g. osteomyelitis, chronic infection, poorly controlled diabetes, cancer, severe autoimmune disorder, epilepsy, poor wound healing)
- Participants with dental caries and a significant risk of dental or periodontal infection
- Chronic oral or intravenous use of steroids or immunosuppressive therapy
- Active cancer within the past year or ongoing chemotherapy
- Uncontrolled autonomic dysreflexia within the past 3 months
- Hydrocephalus with or without an implanted ventricular shunt
- Other chronic, unstable medical conditions that could interfere with subject participation.
- Persistent suicidal ideation within the past 12 months.
- History of substance use disorder within the past year
- Pregnancy (confirmation through blood test)
- Nursing an infant, planning to become pregnant, or not using adequate birth control
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.