AMES + Brain Stimulation

Sponsor

AMES Technology (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01169181

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

Arms

113

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Cerebrovascular Accident Plegia	Device: AMES + brain stimulation	Phase 1

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: AMES + brain stimulation Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.
Active Comparator: 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.	Device: AMES + brain stimulation Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.

Arm

Intervention/Treatment

Active Comparator: 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.

Device: AMES + brain stimulation

Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.

Active Comparator: 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.

Device: AMES + brain stimulation

Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.

Outcome Measures

Primary Outcome Measures

Maximum volitional EMG in the extensor digitorum and the finger flexors [Following each treatment with the AMES device]
EMG intensity will be measured during maximal efforts at hand opening and closing at the end of each treatment session. The averages of 3 attempted openings and 3 closings will be determined and recorded.

Secondary Outcome Measures

Chedoke-McMaster Stroke Assessment [Before the first treatment session, and again after the last treatment session.]
A validated assessment tool for evaluating the severity of physical impairment in adult stroke survivors.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oregon Health and Science University	Portland	Oregon	United States	97239

Sponsors and Collaborators

AMES Technology
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator: Barry Oken, MD, Oregon Health and Science University
Principal Investigator: Paul J. Cordo, PHD, Oregon Health and Science University