Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2010-07-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMES therapy with rTMS
Each subject will participate in 30 therapy sessions over a 10- to 15-week period. A session will last 90 to 120 minutes, which includes 20 minutes of AMES+rTMS, followed by an EMG test. During the hand-opening phase of the AMES therapy, the subjects assigned to the AMES+rTMS treatment group will be subjected to trains of TMS pulses.
AMES + brain stimulation
Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.
AMES therapy with tDCS
Each subject will participate in 30 therapy sessions over a 10- to 15-week period. A session will last 90 to 120 minutes, which includes 20 minutes of AMES+tDCS, followed by an EMG test. A constant current will be applied throughout the entire 20-minute therapy session with the AMES device.
AMES + brain stimulation
Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.
Interventions
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AMES + brain stimulation
Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
AMES Technology
INDUSTRY
Responsible Party
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Principal Investigators
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Barry Oken, MD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Paul J. Cordo, PHD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Locations
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Oregon Health and Science University
Portland, Oregon, United States
Countries
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References
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Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
Other Identifiers
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6237
Identifier Type: -
Identifier Source: org_study_id