Status:
UNKNOWN
AMES + Brain Stimulation
Lead Sponsor:
AMES Technology
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke
Cerebrovascular Accident
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The procedure involves: (1) assisted hand movement by a mechanical device, (2) mechanical vibration applied to the surface of the forearm, and (3) stimulation of the brain with either transcranial mag...
Detailed Description
This protocol is designed to investigate the safety and efficacy of a procedure for treating chronic (\>1 year post) stroke patients who still cannot move the hand affected by the stroke. The treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01169181
Start Date
July 1 2010
End Date
December 1 2019
Last Update
December 8 2016
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239