AMES + Brain Stimulation

Stroke Clinical Trial

— AMES  

Official title:

AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01169181
• Other study ID #: 6237
• Secondary ID: 1R43NS067694-01A
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 22, 2010
• Last updated: December 7, 2016
• Start date: July 2010
• Est. completion date: December 2019

Study information

• Verified date: December 2016
• Source: AMES Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Paralysis
• Plegia
• Stroke

Intervention

Device:
• AMES + brain stimulation
Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.

Locations

Country	Name	City	State
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
AMES Technology	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Following each treatment with the AMES device	No
Secondary	Chedoke-McMaster Stroke Assessment	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.	No