AMES + Brain Stimulation

Phase 1

• Conditions: Cerebrovascular Accident; Plegia; Stroke
• Interventions: Device: AMES + brain stimulation

• Registration Number: NCT01169181
• Lead Sponsor: AMES Technology

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.

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-22
• Study First Submitted QC: 2010-07-22
• Study First Posted: 2010-07-26
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-07
• Last Update Posted: 2016-12-08
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AMES therapy with tDCS	AMES + brain stimulation	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 therapy with rTMS	AMES + brain stimulation	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States