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. 2016 Mar 21;2016(3):CD009645. doi: 10.1002/14651858.CD009645.pub3

NCT01169181.

Trial name or title AMES + brain stimulation: treatment for profound plegia in stroke
Methods Not clearly stated
Participants Estimated enrolment: 6
Inclusion criteria: age 18 to 75 years; stroke more than 1 year prior to enrolment; hemispheric stroke; residual upper‐extremity weakness without the ability to activate finger extension volitionally
Exclusion criteria: significant upper‐extremity proprioceptive deficit; cortical stroke involving M1; unstable epilepsy; Botox injections less than 5 months prior to enrolment; use of intrathecal Baclofen; residual pain in the affected arm; significant neglect involving the affected limb; exercise intolerance; uncontrolled hypertension or angina; cognitive or behavioural inability to follow instructions; terminal illness; severe apraxia; circumference of arm incompatible with the AMES device; contractures, decreased range of motion, or skin condition preventing tolerance of the AMES device (Assisted Motion with Enhanced Sensation); spinal cord injury; arthritis or fractures of affected limbs, decreasing range of motion; peripheral nerve injury or neuropathy in the affected arm resulting in significant motor or sensory loss; other neurological comorbidities; implanted devices; previous vascular surgery on brain or heart blood vessels; pregnancy
Interventions 2 arms
  1. 30 sessions of AMES therapy plus rTMS (20 minutes each) over a 10‐ to 15‐week period

  2. 30 sessions of AMES therapy plus tDCS (20 minutes each) over a 10‐ to 15‐week period

Outcomes Outcomes will be recorded at baseline
Primary outcome
  1. Maximum volitional EMG in extensor digitorum and the finger flexors


Secondary outcome
  1. CMSA

Starting date July 2010
Contact information Jau‐Shin Lou, MD PhD
Oregon Health and Science University
Portland, Oregon, United States, 97239
Notes