Clinical trial NCT01169181: AMES + Brain Stimulation
Official title: AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Stroke
Cerebrovascular Accident
Plegia
Keywords: Stroke
Cerebrovascular Accident
Plegia
Upper Extremity
rTMS
tDCS
Lead sponsor: AMES Technology
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2010-07-26
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 magnetic stimulation (TMS) or transcortical direct current stimulation (DCS). These 3 components of the procedure are carried out simultaneously. Each subject will be evaluated pre- and post-treatment with several clinical tests of functional movement. The hypotheses of this project are that the AMES+rTMS and AMES+tDCS procedures are safe and will enable most of the stroke patients to recover finger extension.

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 treatment 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 magnetic stimulation (TMS) or transcortical direct current stimulation (DCS). Subjects receiving TMS during treatment are expected to respond more fully (i.e., increased volitional EMG) in the treated hand compared to those receiving DCS.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum volitional EMG in the extensor digitorum and the finger flexors
timeFrame: Following each treatment with the AMES device
Secondary outcomes:
measure: Chedoke-McMaster Stroke Assessment
timeFrame: Before the first treatment session, and again after the last treatment session.
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Barry Oken, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Paul J. Cordo, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.