AMES + Brain Stimulation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
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
  Purpose

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 Intervention Phase
Stroke
Cerebrovascular Accident
Plegia
Device: AMES + brain stimulation
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke

Resource links provided by NLM:


Further study details as provided by AMES Technology:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 6
Study Start Date: July 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169181

Locations
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
Sponsors and Collaborators
AMES Technology
Investigators
Principal Investigator: Jau-Shin Lou, MD PhD Oregon Health and Science University
Principal Investigator: Paul J. Cordo, PHD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: AMES Technology
ClinicalTrials.gov Identifier: NCT01169181     History of Changes
Other Study ID Numbers: 6237, 1R43NS067694-01A1
Study First Received: July 22, 2010
Last Updated: May 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by AMES Technology:
Stroke
Cerebrovascular Accident
Plegia
Upper Extremity
rTMS
tDCS

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on October 16, 2014