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StrokeNCT02856035

Novel Brain Signal Feedback Paradigm to Enhance Motor Learning After Stroke

A study testing Neural feedback plus FES and motor training in people with Stroke, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Stroke (795,000/year in the US and 30 million existing stroke survivors in the world) damages brain neural structures that control coordinated upper limb movement. To most effectively target the brain damage, interventions should be directed so as to restore brain control serving coordination of peripheral… Read more about this study

Who is it for?
Ages 21 to 88 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Neural feedback plus FES and motor training
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
1 Jan 2017to 28 Sep 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 88 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Cognition sufficiently intact to give valid informed consent to participate.*
  • Sufficient endurance to participate in rehabilitation sessions.
  • Ability to follow 2 stage commands.
  • Medically Stable
  • Age > 21 years.
  • Impaired upper limb function as follows: impaired ability to flex and extend the wrist.
Show all 9Show fewer
  • At least 5 degrees of wrist flexion and extension of the wrist.
  • Passive ROM of wrist extension of at least 20 degrees.
  • At least 6 months post stroke.

Who cannot join

  • Metal implants, pacemaker, claustrophobia, inability to operate the MRI patient call button or any other contraindications for MRI.
  • Acute or progressive cardiac (including cardiac arrhythmias), renal, respiratory, neurological disorders or malignancy.
  • Active psychiatric diagnosis or psychological condition, or active drug/alcohol abuse.
  • Lower motor neuron damage or radiculopathy.
  • More than one stroke.
  • Pregnancy (discontinued from the study, if a woman becomes pregnant). * The combined scores for the Aid to Capacity Evaluation (ACE) and Mini-Mental Status Examination (MMSE) as follows:
  • MMSE 24-30 + the ACE score that states 'definitely capable'
  • MMSE 17 - 23 + the ACE score that states 'probably capable'

Trial locations and contacts

1 site in 1 country.

United States1 site

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608

Other trials in United States

About this study

Stroke (795,000/year in the US and 30 million existing stroke survivors in the world) damages brain neural structures that control coordinated upper limb movement. To most effectively target the brain damage, interventions should be directed so as to restore brain control serving coordination of peripheral neuromuscular function. Currently, there is a lack of a transformative intervention strategy, and only limited efficacy is seen in response to neural rehabilitation that is only peripherally-directed (limbs e.g.) or only directed at the brain. This study will employ a novel neural feedback approach with a closed-loop, real-time paradigm to engage and retrain existing brain function after stroke. Real-time functional magnetic resonance imaging (rtfMIR) provides neural feedback with the advantage of precisely identifying the location of brain activity for multiple cognitive and emotional tasks. However, the rtfMRI is costly and precludes motor learning that requires sitting and engaging the upper limb in complex motor tasks during imaging acquisition. In contrast, real-time functional near-infrared spectroscopy (rtfNIRS), although not as spatially precise as rtfMRI, offers a low-cost, portable solution to provide brain neural feedback during motor learning. This proposal will utilize both technologies in a hybrid, sequential motor learning protocol. Moreover, the study protocol will also simultaneously involve both central effective signals (through neural feedback) and peripheral affective signals by employing neutrally-triggered functional electrical stimulation (FES)-assisted coordination practice, which produces peripherally-induced affective signals from muscle and joint receptors. This novel combination intervention protocol will engage the central nervous system, motor effective pathway training along with induction of affective signal production (FES-assisted practice), all of which will be implemented within the framework of evidence-based motor learning principles.

Read the detailed description

This study aims to develop and test an innovative protocol for recovery of wrist extension after stroke, using a combination of rtfMRI, rtfNIRS, FES, and motor learning.

Aim I. Test the innovative coordination training protocol of combination rtfMRI/rtfNIRS central neural feedback and peripherally-directed, neurally-triggered FES-assisted coordination practice implemented within a framework of motor learning principles.

Hypothesis 1. Chronic stroke survivors will show significant improvement in upper limb function in response to the combined rtfMRI/rtfNIRS central neural feedback; peripherally-directed FES-assisted coordination practice of wrist and finger extension; and whole arm/hand motor learning (Primary measure: Pre-/post-treatment change score in Arm Motor Abilities Test - function domain (AMAT - F); secondary measure: Pre/post-treatment change score in Fugl-Meyer upper limb coordination.

Conditions
Stroke
Being tested
Neural feedback plus FES and motor training
Keywords
chronic stroke, functional MRI, functional NIRS, motor learning, FES, upper extremity, neural feedback, arm/hand functional training
Medical subject headings
Stroke

What participants receive

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

  • Neural feedback plus FES and motor trainingOther

    We are not testing the feasibility of the imaging methods; that has been well established and is used clinically. We are testing the feasibility of using neural feedback clinical imaging methods in a neural feedback paradigm which involves sequential rtfMRI (phase I) and rtfNIRS (phase II) training; Neurally-triggered, peripherally-directed FES-assist practice of wrist and finger extension will be combined with rtfNIRS training in Phase II; up to 60 total sessions, including additional motor learning sessions without brain neural feedback will be provided in Phase III.

Study groups in NCT02856035
Study groupRoleWhat they receive
Stroke GroupExperimentalIntervention: Stroke subjects will receive neural feedback plus FES and motor learning intervention that spans 3 phases and up to a total of 60 sessions. Phase I: real-time fMRI neural feedback training; Phase II: rtfNIRS-based neural feedback learning (built upon self-regulation strategies learned in Phase I and also assisted by neurally-triggered, peripherally-directed FES motor practice of wrist and finger extension); Phase III: motor learning minus neural feedback for an additional sessions up to 60 total; Phase IV: follow-up testing at 3 months after-treatment ends
Receives: Other: Neural feedback plus FES and motor training

What is being measured

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

  1. Arm Motor Abilities Test Functional Domain (AMAT - F)

    AMAT-F is a measure of 13 complex, coordinated tasks used in everyday living: functional normality of movement during the 13 tasks. Minimum clinically important difference (MCID) is 0.44 change score.

    AMAT-F : Arm Motor Abilities Test, functional domain. minimum = 0 points. maximum = 5 points. 5 points is normal function.

    Measured: change score from baseline to post-treatment; approximately 3 months.

Secondary outcomes (1)

  1. Change Score From Baseline to Post Treatment for the Fugl Meyer Coordination Scale

    FM: Fugl-Meyer Coordination Scale: arm/hand coordination of isolated joint movement. The minimum clinically important difference (MCID) is 4.25 points.

    FM: 0 points, no movement; 66 points, normal coordination throughout the upper limb.

    Measured: from baseline to post-treatment, approximately 3 months

Timeline

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

  1. First posted4 Aug 2016 (estimated)
  2. Study start1 Jan 2017
  3. Primary completion1 Aug 2018
  4. Study completion28 Sep 2018

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
feasibility testing
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02856035
Sponsor's protocol ID
N2192-P
Other IDs
RX2192
Status last verified
May 2020
First submitted
26 Jul 2016
Last updated
21 May 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified, anonymized data-set will be created and shared after manuscript publication. Such data sets will be maintained locally according to the institutional policy and guidelines. De-identified data sets will be made available upon request to the study PI after study completion.

Publications

  • Matarasso AK, Rieke JD, White K, Yusufali MM, Daly JJ. Combined real-time fMRI and real time fNIRS brain computer interface (BCI): Training of volitional wrist extension after stroke, a case series pilot study. PLoS One. 2021 May 6;16(5):e0250431. doi: 10.1371/journal.pone.0250431. eCollection 2021.

    PubMed 33956845

Questions about this trial

What is this clinical trial studying?

A study testing Neural feedback plus FES and motor training in people with Stroke, run by VA Office of Research and Development 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 9 inclusion and 8 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 21 May 2020. 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?

Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Arm Motor Abilities Test Functional Domain (AMAT - F) (time frame: change score from baseline to post-treatment; approximately 3 months.). 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 NCT02856035, 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 21 May 2020.

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