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Mental Imagery Neurofeedback in Strokerehabilitation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03994042
Recruitment Status : Completed
First Posted : June 21, 2019
Last Update Posted : June 30, 2020
Sponsor:
Collaborators:
Danderyd Hospital
Vinnova
Information provided by (Responsible Party):
Mälardalen University

Brief Summary:
This research project will investigate neurofeedback training in stroke rehabilitation during which patients receive feedback in real time from their brain activity measured with ElectroEncephaloGraphy (EEG). The investigators hypothesize that the feedback training allows to internally stimulate brain motor networks in order to promote functional recovery of the hand.

Condition or disease Intervention/treatment Phase
Stroke Hemiparesis Device: Mental imagery neurofeedback training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EEG-based Mental Imagery Feedback in Stroke Patients With Severe Hand Dysfunction
Actual Study Start Date : August 5, 2019
Actual Primary Completion Date : January 17, 2020
Actual Study Completion Date : January 17, 2020

Arm Intervention/treatment
Experimental: Mental imagery neurofeedback training
Complete intervention with mental imagery neurofeedback training. Patients recruited by physioterapists who underwent baseline evaluations with clinical tests, fMRI and EEG measurements. Patients will after intervention perform clinical tests, fMRI, and EEG measurements to evaluate outcomes of intervention.
Device: Mental imagery neurofeedback training
Mental Imagery (MI)-neurofeedback training, 2-3 hours, 3 times/week for 4 weeks.




Primary Outcome Measures :
  1. Change of Fugl-Meyer Upper Extremity scale score (0-66 points) [ Time Frame: Up to 10 weeks ]
    Arm and hand function

  2. Change of EEG alpha and beta activity [ Time Frame: Up to 7 weeks ]
    Brain motor network activity reflected in neurofeedback signal

  3. Change of fMRI BOLD activity [ Time Frame: Up to 7 weeks ]
    Brain motor network activity


Secondary Outcome Measures :
  1. Change of monofilament test score [ Time Frame: Up to 10 weeks ]
    Two point discrimination and monofilament test for sensory function

  2. Change of box and block test score (0-150) [ Time Frame: Up to 10 weeks ]
    Gross manual dexterity

  3. Change of JAMAR® digital Hand Dynamometer scores (0-90) [ Time Frame: Up to 10 weeks ]
    Grip strength

  4. Change of visuomotor force-tracking task scores [ Time Frame: Up to 10 weeks ]
    Quantification of timing and precision aspects of force grip modulation

  5. Change of stroke Impact Scale 16 scores (15-80 points) [ Time Frame: Up to 10 weeks ]
    Activity limitations related to physical function



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • More than 6 months since first time stroke onset and with remaining hemiparesis in upper extremity;
  • able to participate fully in the intervention including screening of cognitive function with the Cambridge Neuropsychological Test Automated Battery;
  • able to perform Functional Magnetic Resonance Imaging (fMRI);
  • able to passively extend the wrist 15 degrees and extend fingers fully with a neutral position of the wrist.

Subgroup 1 (n=2):

  • be able to voluntarily control the power of their grip when requested according to the Visuomotor force tracking method and/or according to the clinical assessment of a therapist (while holding the patient´s hand).
  • Fugl-Meyer Upper Extremity (UE) scale (Fugl-Meyer 1975): <14 points on the hand subscale (C) in addition to < 48 points on the total score (equivalent to moderate disability in the upper extremity

Subgroup 2 (n=2):

- no detected voluntary grip or release function

Exclusion Criteria:

  • Other neurological or musculoskeletal disease/injury, contagious disease or treatment with botulinum toxin in the upper extremity during the past 3 months.
  • current or history of epilepsy, hearing problems, metal implants in the brain/skull cochlear implants, any implanted neurostimulator, cardiac pacemaker or cardiac implants of metal, infusion device.
  • other neurological disorder, pregnancy, current or history of severe psychiatric disorder with need for pharmacological treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03994042


Locations
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Sweden
Stockholn University Brain Imaging C entre
Stockholm, Sweden, 11418
Department of rehabilitation medicine at Danderyd University
Stockholm, Sweden, 18288
Mälardalen University
Västerås, Sweden, 72123
Sponsors and Collaborators
Mälardalen University
Danderyd Hospital
Vinnova
Investigators
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Principal Investigator: Elaine Astrand Mälardalen University
Publications:
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Responsible Party: Mälardalen University
ClinicalTrials.gov Identifier: NCT03994042    
Other Study ID Numbers: 2019-01577
First Posted: June 21, 2019    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Paresis
Nervous System Diseases
Neurologic Manifestations