AMES + Brain Stimulation (AMES)

December 7, 2016 updated by: AMES Technology

AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum volitional EMG in the extensor digitorum and the finger flexors
Time Frame: 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.
Following each treatment with the AMES device

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chedoke-McMaster Stroke Assessment
Time Frame: 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.
Before the first treatment session, and again after the last treatment session.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AMES Technology

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Paul J. Cordo, PHD, Oregon Health and Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

July 22, 2010

First Submitted That Met QC Criteria

July 22, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Estimate)

December 8, 2016

Last Update Submitted That Met QC Criteria

December 7, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6237 (Other Identifier: CTEP)
  • 1R43NS067694-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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