StrokePhase 1AMESNCT01169181

AMES + Brain Stimulation

A Phase 1 study testing AMES + brain stimulation in people with Stroke and Cerebrovascular Accident, run by AMES Technology at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Stroke, Cerebrovascular Accident, Plegia
What is being tested?: AMES + brain stimulation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Jul 2010to Dec 2019
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Oregon Health and Science University
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke

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.

Read the 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.

Conditions: Stroke, Cerebrovascular Accident, Plegia
Being tested: AMES + brain stimulation
Keywords: Stroke, Cerebrovascular Accident, Plegia, Upper Extremity, rTMS, tDCS
Medical subject headings: Stroke, Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01169181
Study group	Role	What they receive
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. Receives: 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. Receives: Device: AMES + brain stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Following each treatment with the AMES device

Secondary outcomes (1)

Chedoke-McMaster Stroke Assessment
A validated assessment tool for evaluating the severity of physical impairment in adult stroke survivors.
Measured: Before the first treatment session, and again after the last treatment session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Dec 2019

First posted26 Jul 2010 (estimated)
Study startJul 2010
Primary completionDec 2018 (estimated)
Study completionDec 2019 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for StrokeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01169181
Sponsor's protocol ID: 6237
Other IDs: 1R43NS067694-01A1
Acronym: AMES
Status last verified: Dec 2016
First submitted: 22 Jul 2010
Last updated: 8 Dec 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 33175411

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AMES + Brain Stimulation: Treatment for Profound Plegia in Stroke
ClinicalTrials.gov ID: NCT01169181
Acronym / sponsor ID: AMES / 6237
Conditions: Stroke, Cerebrovascular Accident, Plegia
Keywords: Stroke, Cerebrovascular Accident, Plegia, Upper Extremity, rTMS, tDCS
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 6 participants (estimated)
Lead sponsor: AMES TechnologyIndustry (pharma, biotech, devices)
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Study start: Jul 2010
Primary completion: Dec 2018 (estimated)
Study completion: Dec 2019 (estimated)
First posted: 26 Jul 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AMES therapy with rTMS	Active comparator	Device: AMES + brain stimulationEach 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 therapy with tDCS	Active comparator	Device: AMES + brain stimulationEach 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (20 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AMES + brain stimulationStroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.	Device	AMES therapy with rTMS, AMES therapy with tDCS

Primary outcome

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

1 secondary outcome

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

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2016.
Derived from this study: PubMed 33175411Elsner 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.
Individual participant dataSharing planned: No

Related trials for Stroke

Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
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Xeomin® and Gait Related Mobility After Stroke
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Barry Oken, MD principal investigator

Oregon Health and Science University

Paul J. Cordo, PHD principal investigator

Oregon Health and Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMES + brain stimulation in people with Stroke and Cerebrovascular Accident, run by AMES Technology at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum volitional EMG in the extensor digitorum and the finger flexors (time frame: Following each treatment with the AMES device). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01169181, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2016.