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AMES + Brain Stimulation (AMES)

Primary Purpose

Stroke, Cerebrovascular Accident, Plegia

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AMES + brain stimulation
Sponsored by
AMES Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Cerebrovascular Accident, Plegia, Upper Extremity, rTMS, tDCS

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Oregon Health and Science University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AMES therapy with rTMS

AMES therapy with tDCS

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maximum volitional EMG in the extensor digitorum and the finger flexors
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
A validated assessment tool for evaluating the severity of physical impairment in adult stroke survivors.

Full Information

First Posted
July 22, 2010
Last Updated
December 7, 2016
Sponsor
AMES Technology
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT01169181
Brief Title
AMES + Brain Stimulation
Acronym
AMES
Official Title
AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AMES Technology
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Cerebrovascular Accident, Plegia
Keywords
Stroke, Cerebrovascular Accident, Plegia, Upper Extremity, rTMS, tDCS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AMES therapy with rTMS
Arm Type
Active Comparator
Arm Description
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.
Arm Title
AMES therapy with tDCS
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
AMES + brain stimulation
Intervention Description
Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.
Primary Outcome Measure Information:
Title
Maximum volitional EMG in the extensor digitorum and the finger flexors
Description
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.
Time Frame
Following each treatment with the AMES device
Secondary Outcome Measure Information:
Title
Chedoke-McMaster Stroke Assessment
Description
A validated assessment tool for evaluating the severity of physical impairment in adult stroke survivors.
Time Frame
Before the first treatment session, and again after the last treatment session.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Oken, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul J. Cordo, PHD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33175411
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.
Results Reference
derived

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AMES + Brain Stimulation

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