StrokeNCT00746525
Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
A study testing Surface functional electrical stimulation (FES), Motor learning and Brain computer interface (BCI) training in people with Stroke, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
The purpose of this trial was to evaluate the benefits of combination motor learning training and brain computer interface training for restoring arm function in people with stroke. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Surface functional electrical stimulation (FES), Motor learning and Brain computer interface (BCI) training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jun 2016
- Phase
- Interventional
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medically stable and >/= 6 months post stroke
- difficulty using upper limb for functional tasks
- >21 years old
Who cannot join
- chronic, progressive medical condition (i.e. Parkinson's disease)
Trial locations and contacts
1 site in 1 country.
United States1 site
Malcom Randall VA Medical Center
Gainesville, Florida, 32608
About this study
The purpose of this trial was to evaluate the benefits of combination motor learning training and brain computer interface training for restoring arm function in people with stroke. Our aim was to determine whether the surface-acquired brain signal (electroencephalography (EEG)) can feasibly be used as a neural feedback system to drive more normal motor function in stroke survivors.
Read the detailed description
The financial burden and human suffering are devastating after stroke due to the lack of rehabilitation protocols that can restore normal brain and motor function. Conventional treatment does not restore normal motor function to many stroke survivors. The majority of available treatments are directed at the peripheral nervous system (arms/legs). Since stroke occurs in the brain and results in brain damage and dysfunction, a more direct approach may be to re-train the brain by directly treating the activation of brain signals that control movement.
The purposes of this study are to determine if motor learning, functional electrical stimulation (FES), and brain computer interface (BCI) training are beneficial for restoring arm function in people who have had a stroke, and to determine if the surface-acquired brain signal [electroencephalography (EEG)] can be re-trained to provide more normal motor function in stroke survivors. The primary purpose of this study is to determine the efficacy of the motor learning tasks in stroke recovery.
In the study, scientists will use two different and complimentary brain signal training components to restore more normal motor control of a motor task (elbow, wrist, or finger movement task). Specifically targeting, invoking, and training the surface-acquired EEG brain signal, and integrating brain signal training into motor learning training of upper limb motor tasks, may result in greater motor restoration when compared to a comprehensive motor learning intervention without EEG brain signal training.
Eight people who had a stroke were enrolled in the experimental group. They received brain signal training and comprehensive motor learning based therapy.
An additional 5 healthy adults were enrolled in order to study their ability to acquire brain signal control and the characteristics of their brain signal during the tasks that the stroke participants attempted.
- Conditions
- Stroke
- Being tested
- Surface functional electrical stimulation (FES), Motor learning, Brain computer interface (BCI) training
- Keywords
- stroke, motor learning, rehabilitation of upper extremity, functional electrical stimulation, FES, brain computer interface, BCI, coordination, motor control
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface functional electrical stimulation (FES)Other
FES is a technique that electrically stimulates a muscle in a comfortable manner in order to contract the muscle. It uses an electrode placed on the surface of the skin. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke.
Motor learningOther
Motor learning is an exercise that uses movements needed for everyday tasks such as picking up a glass or opening a book. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke.
Brain computer interface (BCI) trainingOther
BCI training uses signals produced by the brain to help individuals with stroke move their weak arm. This study will use BCI, FES and motor learning interventions to address upper extremity motor deficits following stroke.
| Study group | Role | What they receive |
|---|---|---|
| Brain Computer Interface Training Stroke Experimental Group | Experimental | Individuals in the stroke experimental group received treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke. Receives: Other: Surface functional electrical stimulation (FES); Other: Motor learning; Other: Brain computer interface (BCI) training |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG (electroencephalography)
measures brain activity during a specified movement task
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janis Daly, North Florida/South Georgia Veterans Health System
- Investigators
- Janis J Daly, PhD, MS, Principal investigator, Malcom Randall VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00746525
- Sponsor's protocol ID
- R01NS063275
- Status last verified
- Jan 2017
- First submitted
- 3 Sep 2008
- Last updated
- 23 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Brain Signal Training to Induce Motor Control Recovery After Stroke
- ClinicalTrials.gov ID
- NCT00746525
- Acronym / sponsor ID
- R01NS063275
- Conditions
- Stroke
- Keywords
- stroke, motor learning, rehabilitation of upper extremity, functional electrical stimulation, FES, brain computer interface, BCI, coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Sep 2008
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Sep 2008 (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.
The purpose of this trial was to evaluate the benefits of combination motor learning training and brain computer interface training for restoring arm function in people with stroke. Our aim was to determine whether the surface-acquired brain signal (electroencephalography (EEG)) can feasibly be used as a neural feedback system to drive more normal motor function in stroke survivors.
Detailed description
The financial burden and human suffering are devastating after stroke due to the lack of rehabilitation protocols that can restore normal brain and motor function. Conventional treatment does not restore normal motor function to many stroke survivors. The majority of available treatments are directed at the peripheral nervous system (arms/legs). Since stroke occurs in the brain and results in brain damage and dysfunction, a more direct approach may be to re-train the brain by directly treating the activation of brain signals that control movement.
The purposes of this study are to determine if motor learning, functional electrical stimulation (FES), and brain computer interface (BCI) training are beneficial for restoring arm function in people who have had a stroke, and to determine if the surface-acquired brain signal [electroencephalography (EEG)] can be re-trained to provide more normal motor function in stroke survivors. The primary purpose of this study is to determine the efficacy of the motor learning tasks in stroke recovery.
In the study, scientists will use two different and complimentary brain signal training components to restore more normal motor control of a motor task (elbow, wrist, or finger movement task). Specifically targeting, invoking, and training the surface-acquired EEG brain signal, and integrating brain signal training into motor learning training of upper limb motor tasks, may result in greater motor restoration when compared to a comprehensive motor learning intervention without EEG brain signal training.
Eight people who had a stroke were enrolled in the experimental group. They received brain signal training and comprehensive motor learning based therapy.
An additional 5 healthy adults were enrolled in order to study their ability to acquire brain signal control and the characteristics of their brain signal during the tasks that the stroke participants attempted.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brain Computer Interface Training Stroke Experimental Group | Experimental | Other: Surface functional electrical stimulation (FES), Other: Motor learning, Other: Brain computer interface (BCI) trainingIndividuals in the stroke experimental group received treatment with BCI, FES, and motor learning targeted at their upper extremity motor deficits following stroke. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- medically stable and >/= 6 months post stroke
- difficulty using upper limb for functional tasks
- >21 years old
Key exclusion criteria (1 listed)
- chronic, progressive medical condition (i.e. Parkinson's disease)
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 |
|---|---|---|
| Surface functional electrical stimulation (FES)FES is a technique that electrically stimulates a muscle in a comfortable manner in order to contract the muscle. It uses an electrode placed on the surface of the skin. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke. | Other | Brain Computer Interface Training Stroke Experimental Group |
| Motor learningMotor learning is an exercise that uses movements needed for everyday tasks such as picking up a glass or opening a book. This study will use BCI, FES, and motor learning interventions to address upper extremity motor deficits following stroke. | Other | Brain Computer Interface Training Stroke Experimental Group |
| Brain computer interface (BCI) trainingBCI training uses signals produced by the brain to help individuals with stroke move their weak arm. This study will use BCI, FES and motor learning interventions to address upper extremity motor deficits following stroke. | Other | Brain Computer Interface Training Stroke Experimental Group |
Primary outcome
EEG (electroencephalography)
Time frame: Week 12
measures brain activity during a specified movement task
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2017.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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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.
Janis J Daly, PhD, MS principal investigator
Malcom Randall VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surface functional electrical stimulation (FES), Motor learning and Brain computer interface (BCI) training in people with Stroke, run by Louis Stokes VA Medical Center 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 23 Jan 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
EEG (electroencephalography) (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2017.