AMES + Brain Stimulation

NCT01169181 | Unknown Phase 1 DMC

• 2 other identifiers: 62371R43NS067694-01A1
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Cerebrovascular Accident; Plegia

Keywords

Stroke; Cerebrovascular Accident; Plegia; Upper Extremity; rTMS; tDCS

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Chedoke-McMaster Stroke Assessment

  Before the first treatment session, and again after the last treatment session.

Study Arms (2)

AMES therapy with rTMS

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.

Device: AMES + brain stimulation

AMES therapy with 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.

Device: AMES + brain stimulation

Interventions

AMES + brain stimulation DEVICE

Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.

AMES therapy with rTMS; AMES therapy with tDCS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AMES Technology: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 33175411 DERIVED

MeSH Terms

Conditions

Stroke; Paralysis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Barry Oken, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Paul J. Cordo, PHD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2010
• First Posted: July 26, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: December 8, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)