AMES + Brain Stimulation

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

Information provided by (Responsible Party):

AMES Technology

ClinicalTrials.gov Identifier:

NCT01169181

First received: July 22, 2010

Last updated: May 17, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

July 22, 2010

Last Updated Date

May 17, 2013

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum volitional EMG in the extensor digitorum and the finger flexors [ Time Frame: Following each treatment with the AMES device ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01169181 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Chedoke-McMaster Stroke Assessment [ Time Frame: Before the first treatment session, and again after the last treatment session. ] [ Designated as safety issue: No ]

A validated assessment tool for evaluating the severity of physical impairment in adult stroke survivors.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

AMES + Brain Stimulation

Official Title ^ICMJE

AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke

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 Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Stroke
Cerebrovascular Accident
Plegia

Intervention ^ICMJE

Device: AMES + brain stimulation

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

Study Arm (s)

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.

Intervention: Device: AMES + brain stimulation
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.

Intervention: Device: AMES + brain stimulation

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01169181

Other Study ID Numbers ^ICMJE

6237, 1R43NS067694-01A1

Has Data Monitoring Committee

Yes

Responsible Party

AMES Technology

Study Sponsor ^ICMJE

AMES Technology

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

Principal Investigator:	Jau-Shin Lou, MD PhD	Oregon Health and Science University
Principal Investigator:	Paul J. Cordo, PHD	Oregon Health and Science University

Information Provided By

AMES Technology

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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