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CompletedNCT05345301Updated Jul 27, 2023

Safety and Feasibility of eGlove

An interventional study of Event related desynchronization measurement in Stroke, sponsored by Shirley Ryan AbilityLab. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-27.

Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

The purpose of this study is to measure how cortical signals improve in stroke participants after passive hand stretching therapy from a robotic glove.

Read the detailed description

After experiencing a stroke event, many individuals are left with life-long motor impairments in their upper extremity. However, motor recovery for stroke survivors is not fully understood. One of the challenges to understand the mechanisms behind recovery is the capability of the brain to reorganize and re-activate areas affected by the stroke. Brain computer interface (BCI) has shown promise in previous studies to improve motor capabilities of individuals with damaged nervous systems by reactivating damaged motor pathways.

In order to understand how BCI can be incorporated into upper extremity rehabilitation, investigators must first lay the groundwork of measuring neural activity and its relation to muscle activity in individuals who have experienced a stroke. While instructing participants to open and close their hand, investigators will measure (1) neural activity, called sensorimotor rhythms (SMRs), using a electrophysiological (EEG) cap, and (2) muscle activity using wireless electromyography (EMGs). What the investigators are specifically looking for is an event in the neural activity in between movement initiation and termination called event related desynchronization (ERD). The investigators of this study hypothesize that there is greater activation of ERDs in stroke's subjects SMR activity after completing finger extension and flexion.

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Conditions studied

  • Stroke

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Keywords

  • Upper Extremity
  • Body Computer Interface
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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's enrollment of 10 is below the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Shirley Ryan AbilityLab is the lead sponsor of 177 studies on the registry; 43 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Ischemic or hemorrhagic stroke (6 months post stroke)
  • Hemiparesis
  • Some degree of hand and finger movement capability
  • a moderate impairment (Fugl-Meyer score between 15-50)

Exclusion criteria

Exclusion Criteria:

  • Individuals under the age of 18
  • Bilateral paresis
  • Hand pain and/or extreme articular contractures on the finger joints (Modified Ashworth Scale of 4)
  • Botox injection to the affected upper extremity within the previous 4 months
  • Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Measuring neural activity

    While completing hand opening/closing, individuals will have the following measured (1) Neural activity (specifically sensorimotor rhythms) using a EEG cap; (2) muscle activity (specifically finger flexors and extensors) using EMG sensors.

    Diagnostic Test: Event related desynchronization measurement

Interventions

  • Diagnostic testEvent related desynchronization measurement

    Individuals will spend one hour and receive cues to open or close their hand while wearing a EEG cap and EMG sensors on their forearm.

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What researchers measure

Primary outcomes

  1. Rate of activation of Event Related Desynchronization

    Sensorimotor neural activity

    Time frame: 1 hour

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Study locations

1 site
  • Shirley Ryan AbilityLab
    Chicago, Illinois 60611, United States
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References and documents

Publications

  • Ang KK, Guan C, Chua KS, Phua KS, Wang C, Chin ZY, Zhou L, Tang KY, Joseph GJ, Kuah C. A clinical study of motor imagery BCI performance in stroke by including calibration data from passive movement. Annu Int Conf IEEE Eng Med Biol Soc. 2013;2013:6603-6. doi: 10.1109/EMBC.2013.6611069. PubMed 24111256 ↗
  • Buch E, Weber C, Cohen LG, Braun C, Dimyan MA, Ard T, Mellinger J, Caria A, Soekadar S, Fourkas A, Birbaumer N. Think to move: a neuromagnetic brain-computer interface (BCI) system for chronic stroke. Stroke. 2008 Mar;39(3):910-7. doi: 10.1161/STROKEAHA.107.505313. Epub 2008 Feb 7. PubMed 18258825 ↗
  • Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, Basso M, Behrman A, Harkema S, Saulino M, Scott M; Spinal Cord Injury Locomotor Trial Group. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized Spinal Cord Injury Locomotor Trial. Neurorehabil Neural Repair. 2007 Jan-Feb;21(1):25-35. doi: 10.1177/1545968306295556. PubMed 17172551 ↗
  • Peles O, Werner-Reiss U, Bergman H, Israel Z, Vaadia E. Phase-Specific Microstimulation Differentially Modulates Beta Oscillations and Affects Behavior. Cell Rep. 2020 Feb 25;30(8):2555-2566.e3. doi: 10.1016/j.celrep.2020.02.005. PubMed 32101735 ↗
  • Triandafilou KM, Kamper DG. Carryover effects of cyclical stretching of the digits on hand function in stroke survivors. Arch Phys Med Rehabil. 2014 Aug;95(8):1571-6. doi: 10.1016/j.apmr.2014.04.008. Epub 2014 May 2. PubMed 24794423 ↗
  • Thielbar KO, Triandafilou KM, Fischer HC, O'Toole JM, Corrigan ML, Ochoa JM, Stoykov ME, Kamper DG. Benefits of Using a Voice and EMG-Driven Actuated Glove to Support Occupational Therapy for Stroke Survivors. IEEE Trans Neural Syst Rehabil Eng. 2017 Mar;25(3):297-305. doi: 10.1109/TNSRE.2016.2569070. Epub 2016 May 17. PubMed 27214905 ↗
  • McFarland DJ, Sarnacki WA, Wolpaw JR. Effects of training pre-movement sensorimotor rhythms on behavioral performance. J Neural Eng. 2015 Dec;12(6):066021. doi: 10.1088/1741-2560/12/6/066021. Epub 2015 Nov 3. PubMed 26529119 ↗
  • Ramos-Murguialday A, Broetz D, Rea M, Laer L, Yilmaz O, Brasil FL, Liberati G, Curado MR, Garcia-Cossio E, Vyziotis A, Cho W, Agostini M, Soares E, Soekadar S, Caria A, Cohen LG, Birbaumer N. Brain-machine interface in chronic stroke rehabilitation: a controlled study. Ann Neurol. 2013 Jul;74(1):100-8. doi: 10.1002/ana.23879. Epub 2013 Aug 7. PubMed 23494615 ↗
  • Seo NJ, Rymer WZ, Kamper DG. Delays in grip initiation and termination in persons with stroke: effects of arm support and active muscle stretch exercise. J Neurophysiol. 2009 Jun;101(6):3108-15. doi: 10.1152/jn.91108.2008. Epub 2009 Apr 8. PubMed 19357330 ↗
  • Yuan H, He B. Brain-computer interfaces using sensorimotor rhythms: current state and future perspectives. IEEE Trans Biomed Eng. 2014 May;61(5):1425-35. doi: 10.1109/TBME.2014.2312397. PubMed 24759276 ↗
  • Prasad G, Herman P, Coyle D, McDonough S, Crosbie J. Applying a brain-computer interface to support motor imagery practice in people with stroke for upper limb recovery: a feasibility study. J Neuroeng Rehabil. 2010 Dec 14;7:60. doi: 10.1186/1743-0003-7-60. PubMed 21156054 ↗
  • Morone NE, Greco CM, Moore CG, Rollman BL, Lane B, Morrow LA, Glynn NW, Weiner DK. A Mind-Body Program for Older Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):329-37. doi: 10.1001/jamainternmed.2015.8033. PubMed 26903081 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05345301
Lead sponsor
Shirley Ryan AbilityLab
Responsible party
James Patton (Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab) — Principal investigator
First posted
Apr 25, 2022
Start date
Mar 28, 2022
Primary completion
Sep 14, 2022
Completion
Sep 14, 2022
Last update
Jul 27, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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