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New treatment option for Stroke, Ischemic
Official title Motor Recovery Through Plasticity-Inducing Cortical Stimulation
ClinicalTrials.gov ID: NCT06506279
What this study is testing
- What it's testing
- Using the CorTec Brain Interchange (BIC) System, we will examine the effect of a plasticity-inducing therapy regime on the rehabilitation of upper limb impairment post-stroke. This study's main objective is to implement and evaluate neuroplasticity-inducing stimulation.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 75
You may be able to join if
- 22-75 years of age
- History of ischemic stroke
- Minimum 6 months post-ischemic cortical stroke
- Levels of hemiparesis that warrant surgical intervention (upper limb impairment)
- Able to participate in a meaningful way in rehabilitation (defined by upper extremity Fugl-Myer (UEFM) score of 25-45
You likely can't join if
- will be assessed within 90 days before the device implantation procedure (though the PI may determine to override the 90-day limit for MRI imaging...
- Unable to discontinue anti-platelet medication for 7 days pre- and 3 days post-op
- On therapeutic anticoagulation
- A history of unprovoked deep vein thrombosis or any pulmonary embolus
- The presence of a bleeding disorder which significantly increases the chances that the patient will have a hemorrhagic complication in relation to...
- Other medical history indicating increased risk of thrombosis per investigator discretion
See the full eligibility criteria
- 22-75 years of age
- History of ischemic stroke
- Minimum 6 months post-ischemic cortical stroke
- Levels of hemiparesis that warrant surgical intervention (upper limb impairment)
- Able to participate in a meaningful way in rehabilitation (defined by upper extremity Fugl-Myer (UEFM) score of 25-45
- Disability measured between 3 and 4 on the modified Rankin Scale
- Minimum of 30% preservation of the corticospinal pathways in MRI imaging
- Observable motor output of the upper limb in response to TMS delivered to the motor cortex
- Available for the duration of the study, 54 weeks for multiple visits (38 weeks implanted and 16 weeks post-explant follow-up).
- All inclusion and
- will be assessed within 90 days before the device implantation procedure (though the PI may determine to override the 90-day limit for MRI imaging results review). Exclusion Criteria:
- Unable to discontinue anti-platelet medication for 7 days pre- and 3 days post-op
- On therapeutic anticoagulation
- A history of unprovoked deep vein thrombosis or any pulmonary embolus
- The presence of a bleeding disorder which significantly increases the chances that the patient will have a hemorrhagic complication in relation to study procedures.
- Other medical history indicating increased risk of thrombosis per investigator discretion
- Any history of seizures
- Pregnancy
- Geriatric Depression Score greater than 10
- Montreal Cognitive Assessment below 22 unless attributable to aphasia and approved by PI
- Columbia Suicide Scale ideation score above 1
- Aphasia or cognitive deficits substantial enough to prevent:
- communication of pain and discomfort due to study procedures
- understanding of motor testing or rehabilitation tasks
- Severe Neglect as measured by NIH Stroke Scale Question 11 score of 2, which represents a "Profound hemi-inattention or extinction to more than one modality; does not recognize own hand or orients to only one side of...
- Cardiac morbidity that in the judgment of the investigators would represent an increased safety risk
- History of spontaneous hemorrhagic stroke
- Major, active neurological, psychiatric, or medical comorbidity that would likely interfere with study procedures
- Any active infection requiring antimicrobial therapy
- Inability to participate with proposed rehabilitation strategies
- Presence of any other implanted devices (cochlear implants, pacemakers, etc.).
- During this study no occupational, physical, or speech therapy is permitted apart from that provided by the study protocol. Patients who require therapy beyond what is delivered in this study will not be enrolled
- All inclusion and exclusion criteria will be assessed within 90 days before the device implantation procedure (though the PI may determine to override the 90-day limit for MRI imaging results review). If a patient has...
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, 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, 22 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, 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.