Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506279
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Motor Recovery Through Plasticity-Inducing Cortical Stimulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MRPICS
Brief Summary:
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 studys main objective is to implement and evaluate neuroplasticity-inducing stimulation The stimulation methods for inducing neuroplasticity have been selected based on prior preclinical and intraoperative work that has shown promise in providing rehabilitative benefits for stroke patients We will be structuring this study as an open prospective feasibility study
Detailed Description:
Stroke is one of the top three causes of human disability In middle- and high-income countries around the world stroke is the leading neurological cause of lost disability-adjusted life years Motor deficits are among the most common results of stroke and contribute substantially to post-stroke disability An estimated 6600000 American adults have had a symptomatic stroke with a prevalence that increases with age Each year 795000 people experience a stroke of which 610000 are first-ever symptomatic strokes The mean survival after stroke is 6-7 years with approximately 85 of patients living past the first year of stroke With the decline in stroke mortality accompanying advances in acute stroke care and aging of the population the disease burden is projected to increase Thus most patients survive their stroke and live with enduring disability for years to come
Between 55 and 75 of patients have enduring motor deficits after stroke which are associated with reduced quality of life and 65 of patients at 6 months are unable to incorporate the affected hand effectively into daily activities Subjective well-being is decreased one year after stroke and some research attributes this decrease directly to arm motor impairments In the long term after a stroke at least half of patients have to rely on human assistance for basic activities of daily living ADLs such as feeding self-care and mobility Upper extremity function is a key part of this disability after stroke Needs assessments from patients include expectations of recovery occupation-specific needs that may require strength vs fine motor skills and activities of daily living all of which will reduce overall disability measures Upper extremity function as measured by the Wolf Motor Function Test WMFT has been shown as a predictor of quality-of-life scores
Current therapies for a new stroke reduce disability in only a subset of patients The only drug approved to treat acute ischemic stroke remains tissue plasminogen activator tPA Only a minor fraction of patients receive this medicine in large part due to the narrow time window for safe drug administration The fraction of patients who receive endovascular therapy is even smaller Moreover of those so treated half or more have significant long-term disability
Physical therapy remains the mainstay of treatment and advances in remote teletherapy and other home or gaming options may further increase its utilization Non-invasive exoskeleton use has also been approved for upper extremity therapy These existing approaches to rehabilitation have been used for decades and are widely recognized to provide important benefits Nevertheless the efficacy of these rehabilitation approaches is equally widely recognized to be limited such that some patients do not respond to rehabilitation and some only show partial recovery These important limitations in the efficacy of existing rehabilitation approaches are likely due to the very nature of physical rehabilitation they engage peripheral nerves and muscles and likely only have indirect effects on damaged physiology in the brain It is equally expected that direct and targeted manipulation of brain physiology has the potential to rehabilitate people with chronic stroke more effectively Thus there has been a growing interest in using electric or magnetic stimulation of the cortex or cortical pathways to promote brain recovery and to enhance structural and functional brain plasticity
The study proposes to investigate the effectiveness of promoting interactions between affected and intact cortical regions by inducing neural plasticity through specific protocols By inducing plasticity through the use of closed-loop stimulation delivered simultaneously with conventional activity-based therapy the study results are expected to enhance recovery beyond what is achievable with therapy alone
Between 55 and 75 of patients have enduring motor deficits after stroke which are associated with reduced quality of life and 65 of patients at 6 months are unable to incorporate the affected hand effectively into daily activities Subjective well-being is decreased one year after stroke and some research attributes this decrease directly to arm motor impairments In the long term after a stroke at least half of patients have to rely on human assistance for basic activities of daily living ADLs such as feeding self-care and mobility Upper extremity function is a key part of this disability after stroke Needs assessments from patients include expectations of recovery occupation-specific needs that may require strength vs fine motor skills and activities of daily living all of which will reduce overall disability measures Upper extremity function as measured by the Wolf Motor Function Test WMFT has been shown as a predictor of quality-of-life scores
Current therapies for a new stroke reduce disability in only a subset of patients The only drug approved to treat acute ischemic stroke remains tissue plasminogen activator tPA Only a minor fraction of patients receive this medicine in large part due to the narrow time window for safe drug administration The fraction of patients who receive endovascular therapy is even smaller Moreover of those so treated half or more have significant long-term disability
Physical therapy remains the mainstay of treatment and advances in remote teletherapy and other home or gaming options may further increase its utilization Non-invasive exoskeleton use has also been approved for upper extremity therapy These existing approaches to rehabilitation have been used for decades and are widely recognized to provide important benefits Nevertheless the efficacy of these rehabilitation approaches is equally widely recognized to be limited such that some patients do not respond to rehabilitation and some only show partial recovery These important limitations in the efficacy of existing rehabilitation approaches are likely due to the very nature of physical rehabilitation they engage peripheral nerves and muscles and likely only have indirect effects on damaged physiology in the brain It is equally expected that direct and targeted manipulation of brain physiology has the potential to rehabilitate people with chronic stroke more effectively Thus there has been a growing interest in using electric or magnetic stimulation of the cortex or cortical pathways to promote brain recovery and to enhance structural and functional brain plasticity
The study proposes to investigate the effectiveness of promoting interactions between affected and intact cortical regions by inducing neural plasticity through specific protocols By inducing plasticity through the use of closed-loop stimulation delivered simultaneously with conventional activity-based therapy the study results are expected to enhance recovery beyond what is achievable with therapy alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None