NCT04048083

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2014

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2016

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.5 years

First QC Date

August 2, 2019

Last Update Submit

August 2, 2019

Conditions

Amelia of Upper Limb

Keywords

bilateral upper limb congenital transverse deficiencyneuroplasticitysensorimotor cortexmental trainingvirtual environment

Outcome Measures

Primary Outcomes (32)

  • Magnetic Resonance Imaging (MRI)

    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

    Before trainings period (PRE)

  • Magnetic Resonance Imaging (MRI)

    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

    After 4 weeks of trainings period (POST4)

  • Magnetic Resonance Imaging (MRI)

    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

    After 8 weeks of trainings period (POST8)

  • Magnetic Resonance Imaging (MRI)

    To evaluate structural changes in central nervous system (CNS) the MRI method will be used

    After 12 weeks of trainings period (POST12)

  • Functional Magnetic Resonance Imaging (fMRI)

    To evaluate functional changes in CNS, the fMRI will be used

    Before trainings period (PRE)

  • Functional Magnetic Resonance Imaging (fMRI)

    To evaluate functional changes in CNS, the fMRI will be used

    After 4 weeks of trainings period (POST4)

  • Functional Magnetic Resonance Imaging (fMRI)

    To evaluate functional changes in CNS, the fMRI will be used

    After 8 weeks of trainings period (POST8)

  • Functional Magnetic Resonance Imaging (fMRI)

    To evaluate functional changes in CNS, the fMRI will be used

    After 12 weeks of trainings period (POST12)

  • Transcranial magnetic stimulation (TMS)

    To evaluate excitability of the sensory-motor cortex of the brain.

    Before trainings period (PRE)

  • Transcranial magnetic stimulation (TMS)

    To evaluate excitability of the sensory-motor cortex of the brain.

    After 4 weeks of trainings period (POST4)

  • Transcranial magnetic stimulation (TMS)

    To evaluate excitability of the sensory-motor cortex of the brain.

    After 8 weeks of trainings period (POST8)

  • Transcranial magnetic stimulation (TMS)

    To evaluate excitability of the sensory-motor cortex of the brain.

    After 12 weeks of trainings period (POST12)

  • Electroencephalography (EEG)

    To evaluate functional changes in CNS, the 128-channels EEG will be used.

    Before trainings period (PRE)

  • Electroencephalography (EEG)

    To evaluate functional changes in CNS, the 128-channels EEG will be used.

    After 4 weeks of trainings period (POST4)

  • Electroencephalography (EEG)

    To evaluate functional changes in CNS, the 128-channels EEG will be used.

    After 8 weeks of trainings period (POST8)

  • Electroencephalography (EEG)

    To evaluate functional changes in CNS, the 128-channels EEG will be used.

    After 12 weeks of trainings period (POST12)

  • Near-infrared spectroscopy (NIRS)

    To evaluate functional changes in peripheral nervous system.

    Before trainings period (PRE)

  • Near-infrared spectroscopy (NIRS)

    To evaluate functional changes in peripheral nervous system.

    After 4 weeks of trainings period (POST4)

  • Near-infrared spectroscopy (NIRS)

    To evaluate functional changes in peripheral nervous system.

    After 8 weeks of trainings period (POST8)

  • Near-infrared spectroscopy (NIRS)

    To evaluate functional changes in peripheral nervous system.

    After 12 weeks of trainings period (POST12)

  • Electromyography (EMG)

    To evaluate functional changes in muscles of upper extremity stump

    Before trainings period (PRE)

  • Electromyography (EMG)

    To evaluate functional changes in muscles of upper extremity stump

    After 4 weeks of trainings period (POST4)

  • Electromyography (EMG)

    To evaluate functional changes in muscles of upper extremity stump

    After 8 weeks of trainings period (POST8)

  • Electromyography (EMG)

    To evaluate functional changes in muscles of upper extremity stump

    After 12 weeks of trainings period (POST12)

  • Mechanomyography (MMG)

    To evaluate functional changes in muscles of upper extremity stump

    Before trainings period (PRE)

  • Mechanomyography (MMG)

    To evaluate functional changes in muscles of upper extremity stump

    After 4 weeks of trainings period (POST4)

  • Mechanomyography (MMG)

    To evaluate functional changes in muscles of upper extremity stump

    After 8 weeks of trainings period (POST8)

  • Mechanomyography (MMG)

    To evaluate functional changes in muscles of upper extremity stump

    After 12 weeks of trainings period (POST12)

  • Temperature measurements (Temp)

    To evaluate functional changes in muscles of upper extremity stump

    Before trainings period (PRE)

  • Temperature measurements (Temp)

    To evaluate functional changes in muscles of upper extremity stump

    After 4 weeks of trainings period (POST4)

  • Temperature measurements (Temp)

    To evaluate functional changes in muscles of upper extremity stump

    After 8 weeks of trainings period (POST8)

  • Temperature measurements (Temp)

    To evaluate functional changes in muscles of upper extremity stump

    After 12 weeks of trainings period (POST12)

Study Arms (4)

Patients-MT

EXPERIMENTAL

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-CAT

EXPERIMENTAL

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-CAMT

EXPERIMENTAL

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

Healthy-controls

ACTIVE COMPARATOR

9 Healthy, age and gender-matched subjects, without any kind of training

Other: No trainings

Interventions

Mental trainingsBEHAVIORAL

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.

Patients-MT
Computer-aided trainingsBEHAVIORAL

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.

Patients-CAT
Computer-aided and mental trainingsBEHAVIORAL

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).

Patients-CAMT
No trainingsOTHER

Healthy controls without any kind of training

Healthy-controls

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University School of Physical Education in Wroclaw

Wroclaw, Lower Silesian Voivodeship, 51 612, Poland

RECRUITING

Related Publications (3)

  • Kurzynski M, Jaskolska A, Marusiak J, Wolczowski A, Bierut P, Szumowski L, Witkowski J, Kisiel-Sajewicz K. Computer-aided training sensorimotor cortex functions in humans before the upper limb transplantation using virtual reality and sensory feedback. Comput Biol Med. 2017 Aug 1;87:311-321. doi: 10.1016/j.compbiomed.2017.06.010. Epub 2017 Jun 15.

    PMID: 28641235BACKGROUND

  • Mencel J, Marusiak J, Jaskolska A, Kaminski L, Kurzynski M, Wolczowski A, Jaskolski A, Kisiel-Sajewicz K. Motor imagery training of goal-directed reaching in relation to imagery of reaching and grasping in healthy people. Sci Rep. 2022 Nov 3;12(1):18610. doi: 10.1038/s41598-022-21890-1.

    PMID: 36329083DERIVED

  • Mencel J, Jaskolska A, Marusiak J, Kaminski L, Kurzynski M, Wolczowski A, Jaskolski A, Kisiel-Sajewicz K. Motor Imagery Training of Reaching-to-Grasp Movement Supplemented by a Virtual Environment in an Individual With Congenital Bilateral Transverse Upper-Limb Deficiency. Front Psychol. 2021 Mar 22;12:638780. doi: 10.3389/fpsyg.2021.638780. eCollection 2021.

    PMID: 33828507DERIVED

Study Officials

  • Katarzyna Kisiel-Sajewicz, PhD

    Wroclaw University of Health and Sport Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrzej Rokita, PhD

CONTACT

713473101rektor@awf.wroc.pl

Joanna Mencel, MSc

CONTACT

71 3473531joanna.mencel@awf.wroc.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

August 2, 2019

First Posted

August 7, 2019

Study Start

March 11, 2014

Primary Completion

September 9, 2016

Study Completion

December 1, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

PL(1)