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NCT02856035 · ClinicalTrials.gov registry record · NA

Novel Brain Signal Feedback Paradigm to Enhance Motor Learning After Stroke

A NA study of Stroke, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
4
Enrollment target
1
Study location

NCT02856035: Completed NA study of Stroke, sponsored by VA Office of Research and Development.

NCT02856035 is a NA study of Stroke that has completed, run by VA Office of Research and Development. The registered enrollment target is 4 participants, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02856035, a NA study of Stroke, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
4 participants
Enrollment target
1
Study location

Study 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 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 pr

Primary Outcome

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.

Conditions Studied

Interventions

  • OTHER Neural feedback plus FES and motor training

Study Locations (1)

Florida

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

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2017-01-01
Est. Completion 2018-09-28
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT02856035 record still lists

NCT02856035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 12,016-participant average among 454 other Stroke trials with a reported enrollment target (100% lower).

The record links to 1 condition, with Stroke appearing as the primary indexed condition, and to 1 intervention - of which Neural feedback plus FES and motor training is the first listed.

NCT02856035 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT02856035 about?

NCT02856035 is a clinical study titled "Novel Brain Signal Feedback Paradigm to Enhance Motor Learning After Stroke". 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 per...

What is the current status of trial NCT02856035?

This trial is currently completed. It is a NA study. The enrollment target is 4 participants. The study started on 2017-01-01. Estimated completion is 2018-09-28.

What conditions does trial NCT02856035 study?

This clinical trial studies the following conditions: Stroke.

What interventions are being tested in trial NCT02856035?

The interventions under investigation include: Neural feedback plus FES and motor training (OTHER).

Who is sponsoring clinical trial NCT02856035?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02856035 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Stroke

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02856035's enrollment target sits among peer trials

4 445th of 454 higher than 8 of 454 other Stroke trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02856035, the US trial registry maintained by the National Library of Medicine. NCT02856035 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.