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Computer-aided and Mental Trainings Induced Plasticity of Sensorimotor Cortex in Patients Born Without Upper Limbs

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ClinicalTrials.gov Identifier: NCT04048083
Recruitment Status : Recruiting
First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Wrocław University of Science and Technology
Kessler Foundation
Nencki Institute of Experimental Biology, Warsaw, Poland
Hospital of St. Hedwig in Trzebnica
Information provided by (Responsible Party):
Jaroslaw Marusiak, University School of Physical Education in Wroclaw

Brief Summary:
This project will explore a potentially powerful trainings that may be administered before upper extremity transplantation to induced plasticity of sensorimotor cortex in humans with congenital absence of upper limbs. We believe that engaging this population to computer-aided and/or mental trainings would facilitate structural and functional reorganization of the brain to promote motor function recovery.

Condition or disease Intervention/treatment Phase
Amelia of Upper Limb Behavioral: Mental trainings Behavioral: Computer-aided trainings Behavioral: Computer-aided and mental trainings Other: No trainings Not Applicable

Detailed Description:

This project will explore a potentially powerful trainings that may be administered before upper extremity transplantation to induced plasticity of sensorimotor cortex in humans with congenital absence of upper limbs.

Our aim is to compare neurophysiological outcome of bilateral upper limb congenital transverse deficiency humans who are engaged in different types of training (mental-MT, computer-aided training-CAT and subjects receiving both type of trainings-CAMT). We hypothesize that all forms of training provide plastic changes in sensorimotor cortex. Specifically, we hypothesize that for CAMT group we will observe more prompt CNS-reorganization as compared to MT and CAT groups.

Our second aim is to examine mechanisms of neural and muscular system plasticity underlying neurophysiological function reorganization following the specific training and also to develop a computer system for training subjects through visual biofeedback. The control procedure of virtual upper extremity should be realized through recognition of intention of hand motion based on biosignals analysis.

Our protocol contains twelve weeks of trainings with three training sessions during a week (on Monday, Wednesday and Friday) and four measurement sessions (before the training period - PRE, after 4 weeks of trainings - POST4, after 8 weeks of trainings - POST8 and after 12 weeks of training - POST12).

Based on different methods we will use, we would like to ewaluate: structural changes in CNS, functional changes in CNS, functional changes in peripheral nervous system and functional changes in muscles of upper extremity stump by comparing results to the pre-training (PRE) values (with results from POST4, POST8 and POST12) and across the groups.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Mental and Computer-aided Training of Reaching and Grasping Movements on Motor Control Processes in People With Bilateral Upper Limb Congenital Transverse Deficiency
Actual Study Start Date : March 11, 2014
Actual Primary Completion Date : September 9, 2016
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
Experimental: Patients-MT
3 Patients with bilateral upper limb congenital transverse deficiency that participated in kinesthetic mental training (MT) of reaching to grasp movements
Behavioral: Mental trainings
Patients will receive 36 trainings (12 weeks with 3 trainings a week) of mental, kinesthetic reaching-to-grasp movement. During each training session they will perform 3 practice trials by following the instructions, after practicing 3 trials, the instructions will be discontinued, and subjects will perform 30 mental movements by following auditory cues.

Experimental: Patients-CAT
3 Patients with bilateral upper limb congenital transverse deficiency that participated in computer-aided training (CAT) of reaching to grasp movements using virtual environment with visual-feedback.
Behavioral: Computer-aided trainings
Patients will receive 36 trainings (12 weeks with 3 trainings a week) of visual feedback of reaching-to-grasp movement. During each training session they will be sitting on a chair, in front of a computer screen observing simple tasks of reaching and precision fine grasping of a small object with 4 fingers of virtual upper extremity using the visualization software that will be coded specifically for the purpose of this experiment.

Experimental: Patients-CAMT
3 Patients with bilateral upper limb congenital transverse deficiency that participated in kinesthetic mental training of reaching to grasp movements supplemented by virtual environment (patients that received both types of training).
Behavioral: Computer-aided and mental trainings
Patients will receive 36 trainings (12 weeks with 3 trainings a week) of mental, kinesthetic reaching-to-grasp movement that will be supplemented by visual feedback of this task by the visualization software that will be coded specifically for the purpose of this experiment (they will receive trainings that link the features of the two mentioned above types of training (MT and CAT).

Active Comparator: Healthy-controls
9 Healthy, age and gender-matched subjects, without any kind of training
Other: No trainings
Healthy controls without any kind of training




Primary Outcome Measures :
  1. Magnetic Resonance Imaging (MRI) [ Time Frame: Before trainings period (PRE) ]
    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

  2. Magnetic Resonance Imaging (MRI) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

  3. Magnetic Resonance Imaging (MRI) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

  4. Magnetic Resonance Imaging (MRI) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

  5. Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: Before trainings period (PRE) ]
    To evaluate functional changes in CNS, the fMRI will be used

  6. Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate functional changes in CNS, the fMRI will be used

  7. Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate functional changes in CNS, the fMRI will be used

  8. Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate functional changes in CNS, the fMRI will be used

  9. Transcranial magnetic stimulation (TMS) [ Time Frame: Before trainings period (PRE) ]
    To evaluate excitability of the sensory-motor cortex of the brain.

  10. Transcranial magnetic stimulation (TMS) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate excitability of the sensory-motor cortex of the brain.

  11. Transcranial magnetic stimulation (TMS) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate excitability of the sensory-motor cortex of the brain.

  12. Transcranial magnetic stimulation (TMS) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate excitability of the sensory-motor cortex of the brain.

  13. Electroencephalography (EEG) [ Time Frame: Before trainings period (PRE) ]
    To evaluate functional changes in CNS, the 128-channels EEG will be used.

  14. Electroencephalography (EEG) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate functional changes in CNS, the 128-channels EEG will be used.

  15. Electroencephalography (EEG) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate functional changes in CNS, the 128-channels EEG will be used.

  16. Electroencephalography (EEG) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate functional changes in CNS, the 128-channels EEG will be used.

  17. Near-infrared spectroscopy (NIRS) [ Time Frame: Before trainings period (PRE) ]
    To evaluate functional changes in peripheral nervous system.

  18. Near-infrared spectroscopy (NIRS) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate functional changes in peripheral nervous system.

  19. Near-infrared spectroscopy (NIRS) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate functional changes in peripheral nervous system.

  20. Near-infrared spectroscopy (NIRS) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate functional changes in peripheral nervous system.

  21. Electromyography (EMG) [ Time Frame: Before trainings period (PRE) ]
    To evaluate functional changes in muscles of upper extremity stump

  22. Electromyography (EMG) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate functional changes in muscles of upper extremity stump

  23. Electromyography (EMG) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate functional changes in muscles of upper extremity stump

  24. Electromyography (EMG) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate functional changes in muscles of upper extremity stump

  25. Mechanomyography (MMG) [ Time Frame: Before trainings period (PRE) ]
    To evaluate functional changes in muscles of upper extremity stump

  26. Mechanomyography (MMG) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate functional changes in muscles of upper extremity stump

  27. Mechanomyography (MMG) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate functional changes in muscles of upper extremity stump

  28. Mechanomyography (MMG) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate functional changes in muscles of upper extremity stump

  29. Temperature measurements (Temp) [ Time Frame: Before trainings period (PRE) ]
    To evaluate functional changes in muscles of upper extremity stump

  30. Temperature measurements (Temp) [ Time Frame: After 4 weeks of trainings period (POST4) ]
    To evaluate functional changes in muscles of upper extremity stump

  31. Temperature measurements (Temp) [ Time Frame: After 8 weeks of trainings period (POST8) ]
    To evaluate functional changes in muscles of upper extremity stump

  32. Temperature measurements (Temp) [ Time Frame: After 12 weeks of trainings period (POST12) ]
    To evaluate functional changes in muscles of upper extremity stump



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for patients:

  • Age between 18 and 25 years
  • Health status: bilateral upper limb congenital transverse deficiency individuals. Subjects must be free from neurological impairment. The subjects must have no current or past history of central or peripheral nervous system dysfunction, be taking no current medication known to affect the neuromuscular system, have no greater than moderate consumption of alcohol or caffeine, and be able to remain seated for 1 hour 30 min and lay supine without moving for 30 min (MRI test). All recruited subjects will be interviewed and their health status and medical history will be evaluated by a medical practitioner qualified to practice surgery and transplant surgery.
  • Training history: Subjects not participating in any type of training program in the last 5 years
  • Right Hemispheric Dominance. We will use Foot Dominance test - Observation of our subjects to see which foot they use to kick a ball, step up onto a stair, and step onto a coin placed on the floor.
  • Availability and interest: All candidates for the study must be available for the familiarization, training, and testing sessions and must have transportation to these sessions.

Exclusion Criteria for patients:

  • Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
  • Taking medication that affects the neuromuscular system
  • Left hemispheric dominance
  • Participation in training over the last five years

Inclusion Criteria for control subjects:

  • Age between 18 and 25 years
  • Health status: subjects must be free from neurological and neuromuscular system impairment. The subjects must have no current or past history of central or peripheral nervous system dysfunction, be taking no current medication known to affect the neuromuscular system, have no greater than moderate consumption of alcohol or caffeine, and be able to remain seated for 1 hour 30 min and lay supine without moving for 30 min (MRI test). ). All recruited subjects will be interviewed and their health status and medical history evaluated by neurologist.
  • Training history: subjects not participating in any type of training program in the last 5 years.
  • Hemispheric Dominance -right. We will use The Edinburgh inventory (Oldfield, 1971) and Foot Dominance test.
  • Availability and interest - All subjects for the study must be available for the familiarization, training, and testing sessions and must have transportation to these sessions.

Exclusion Criteria for control subjects:

  • Presence of neurological impairment (history of central or peripheral nervous system dysfunction)
  • Taking medication that affects the neuromuscular system
  • Left hemispheric dominance
  • Participation in training over the last five years

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): NCT04048083


Contacts
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Contact: Andrzej Rokita, PhD 713473101 ext +48 rektor@awf.wroc.pl
Contact: Joanna Mencel, MSc 71 3473531 ext +48 joanna.mencel@awf.wroc.pl

Locations
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Poland
University School of Physical Education in Wroclaw Recruiting
Wroclaw, Lower Silesia, Poland, 51 612
Contact: Katarzyna Kisiel-Sajewicz, PhD    71 347 3534 ext +48    katarzyna.kisiel-sajewicz@awf.wroc.pl   
Contact: Joanna Mencel, MSc    71 347 3531 ext +48    joanna.mencel@awf.wroc.pl   
Sponsors and Collaborators
University School of Physical Education in Wroclaw
Wrocław University of Science and Technology
Kessler Foundation
Nencki Institute of Experimental Biology, Warsaw, Poland
Hospital of St. Hedwig in Trzebnica
Investigators
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Principal Investigator: Katarzyna Kisiel-Sajewicz, PhD University School of Physical Education in Wroclaw

Publications:
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Responsible Party: Jaroslaw Marusiak, Co-Investigator, University School of Physical Education in Wroclaw
ClinicalTrials.gov Identifier: NCT04048083     History of Changes
Other Study ID Numbers: DEC-2011/03/B/NZ7/00588
First Posted: August 7, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jaroslaw Marusiak, University School of Physical Education in Wroclaw:
bilateral upper limb congenital transverse deficiency
neuroplasticity
sensorimotor cortex
mental training
virtual environment