AMES + Brain Stimulation "AMES"

Active, not recruiting

Phase 1 Results N/A

Update History

4 Dec '12
The eligibility criteria were updated.
New
Inclusion Criteria: - Stroke occurring ≥12 months before enrollment - Hemispheric stroke (ischemic or hemorrhagic), cortical or subcortical - Residual upper-extremity weakness without the ability to activate volitionally extensor digitorum (no volitional EMG in the long finger extensor muscle)independently - Age 18-75 years old Exclusion Criteria: - Significant upper-extremity proprioceptive deficit (<70% correct detection of the direction of passive finger movement, with eyes closed) - Cortical stroke involving the primary motor cortex - Epilepsy not controlled by medication - Botox injections 5 months before or during enrollment; use of intrathecal Baclofen - Residual pain in the tested arm - Significant neglect involving the affected limb (NIHSS 2 on the extinction and attention items) - Exercise intolerant - Uncontrolled hypertension or angina - Cognitive or behavioral inability to follow instructions - Current abuse of alcohol or drugs - Terminal illness with anticipated survival of <12 months - Severe apraxia; inability to understand oral directions in English; or inability to communicate adequately with study personnel - Circumference of arm incompatible with the AMES device (checked by placing the limb in the device) - Contractures, decreased range of motion, or skin condition preventing tolerance of the AMES muscle vibrators - Spinal cord injury, arthritis, or fractures of affected limbs resulting in loss of range of motion - In the tested arm, peripheral nerve injury or neuropathy resulting in significant motor or sensory loss - Pathological neurological/physical condition other than stroke that impairs the function of the impaired arm or that produces pain in the impaired arm - Implanted device (e.g., cardiac pacemaker, Baclofen pump) the operation of which might be adversely affected by the brain stimulation - Previous vascular surgery on the blood vessels of the brain or heart or heart valve surgery - Female and pregnant
Old
Inclusion Criteria: - Stroke occurring ≥12 months before enrollment - Hemispheric stroke (ischemic or hemorrhagic), cortical or subcortical - Residual upper-extremity weakness without the ability to activate volitionally extensor digitorum (no volitional EMG in the long finger extensor muscle) - Age 18-75 years old Exclusion Criteria: - Significant upper-extremity proprioceptive deficit (<70% correct detection of the direction of passive finger movement, with eyes closed) - Cortical stroke involving the primary motor cortex - Epilepsy not controlled by medication - Botox injections 5 months before or during enrollment; use of intrathecal Baclofen - Residual pain in the tested arm - Significant neglect involving the affected limb (NIHSS 2 on the extinction and attention items) - Exercise intolerant - Uncontrolled hypertension or angina - Cognitive or behavioral inability to follow instructions - Current abuse of alcohol or drugs - Terminal illness with anticipated survival of <12 months - Severe apraxia; inability to understand oral directions in English; or inability to communicate adequately with study personnel - Circumference of arm incompatible with the AMES device (checked by placing the limb in the device) - Contractures, decreased range of motion, or skin condition preventing tolerance of the AMES muscle vibrators - Spinal cord injury, arthritis, or fractures of affected limbs resulting in loss of range of motion - In the tested arm, peripheral nerve injury or neuropathy resulting in significant motor or sensory loss - Pathological neurological/physical condition other than stroke that impairs the function of the impaired arm or that produces pain in the impaired arm - Implanted device (e.g., cardiac pacemaker, Baclofen pump) the operation of which might be adversely affected by the brain stimulation - Previous vascular surgery on the blood vessels of the brain or heart or heart valve surgery - Female and pregnant
5 May '12
A location was updated in Portland.
New
The overall status was removed for Oregon Health and Science University.
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - Stroke occurring ≥12 months before enrollment - Hemispheric stroke (ischemic or hemorrhagic), cortical or subcortical - Residual upper-extremity weakness without the ability to activate volitionally extensor digitorum (no volitional EMG in the long finger extensor muscle) - Age 18-75 years old Exclusion Criteria: - Significant upper-extremity proprioceptive deficit (<70% correct detection of the direction of passive finger movement, with eyes closed) - Cortical stroke involving the primary motor cortex - Epilepsy not controlled by medication - Botox injections 5 months before or during enrollment; use of intrathecal Baclofen - Residual pain in the tested arm - Significant neglect involving the affected limb (NIHSS 2 on the extinction and attention items) - Exercise intolerant - Uncontrolled hypertension or angina - Cognitive or behavioral inability to follow instructions - Current abuse of alcohol or drugs - Terminal illness with anticipated survival of <12 months - Severe apraxia; inability to understand oral directions in English; or inability to communicate adequately with study personnel - Circumference of arm incompatible with the AMES device (checked by placing the limb in the device) - Contractures, decreased range of motion, or skin condition preventing tolerance of the AMES muscle vibrators - Spinal cord injury, arthritis, or fractures of affected limbs resulting in loss of range of motion - In the tested arm, peripheral nerve injury or neuropathy resulting in significant motor or sensory loss - Pathological neurological/physical condition other than stroke that impairs the function of the impaired arm or that produces pain in the impaired arm - Implanted device (e.g., cardiac pacemaker, Baclofen pump) the operation of which might be adversely affected by the brain stimulation - Previous vascular surgery on the blood vessels of the brain or heart or heart valve surgery - Female and pregnant
Old
Inclusion Criteria: - Stroke occurring ?12 months before enrollment - Hemispheric stroke (ischemic or hemorrhagic), cortical or subcortical - Residual upper-extremity weakness without the ability to activate volitionally extensor digitorum (no volitional EMG in the long finger extensor muscle) - Age 18-75 years old Exclusion Criteria: - Significant upper-extremity proprioceptive deficit (<70% correct detection of the direction of passive finger movement, with eyes closed) - Cortical stroke involving the primary motor cortex - Epilepsy not controlled by medication - Botox injections 5 months before or during enrollment; use of intrathecal Baclofen - Residual pain in the tested arm - Significant neglect involving the affected limb (NIHSS 2 on the extinction and attention items) - Exercise intolerant - Uncontrolled hypertension or angina - Cognitive or behavioral inability to follow instructions - Current abuse of alcohol or drugs - Terminal illness with anticipated survival of <12 months - Severe apraxia; inability to understand oral directions in English; or inability to communicate adequately with study personnel - Circumference of arm incompatible with the AMES device (checked by placing the limb in the device) - Contractures, decreased range of motion, or skin condition preventing tolerance of the AMES muscle vibrators - Spinal cord injury, arthritis, or fractures of affected limbs resulting in loss of range of motion - In the tested arm, peripheral nerve injury or neuropathy resulting in significant motor or sensory loss - Pathological neurological/physical condition other than stroke that impairs the function of the impaired arm or that produces pain in the impaired arm - Implanted device (e.g., cardiac pacemaker, Baclofen pump) the operation of which might be adversely affected by the brain stimulation - Previous vascular surgery on the blood vessels of the brain or heart or heart valve surgery - Female and pregnant