Overview

This trial is active, not recruiting.

Conditions stroke, cerebrovascular accident, plegia
Treatment ames + brain stimulation
Phase phase 1
Sponsor AMES Technology
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date July 2010
End date December 2018
Trial size 6 participants
Trial identifier NCT01169181, 1R43NS067694-01A1, 6237

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
ames + brain stimulation
Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.
(Active Comparator)
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 + brain stimulation
Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.

Primary Outcomes

Measure
Maximum volitional EMG in the extensor digitorum and the finger flexors
time frame: Following each treatment with the AMES device

Secondary Outcomes

Measure
Chedoke-McMaster Stroke Assessment
time frame: Before the first treatment session, and again after the last treatment session.

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke
Principal investigator Barry Oken, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by AMES Technology.