Clinical trial NCT04048083: Computer-aided and Mental Trainings Induced Plasticity of Sensorimotor Cortex in Patients Born Without Upper Limbs
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amelia of Upper Limb
Keywords: bilateral upper limb congenital transverse deficiency
neuroplasticity
sensorimotor cortex
mental training
virtual environment
Lead sponsor: Wroclaw University of Health and Sport Sciences
Sponsor class: OTHER
Collaborators: name: Wrocław University of Science and Technology
name: Kessler Foundation
name: Nencki Institute of Experimental Biology, Warsaw, Poland
name: Hospital of St. Hedwig in Trzebnica
First posted: 2019-08-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Magnetic Resonance Imaging (MRI)
timeFrame: Before trainings period (PRE)
measure: Magnetic Resonance Imaging (MRI)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Magnetic Resonance Imaging (MRI)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Magnetic Resonance Imaging (MRI)
timeFrame: After 12 weeks of trainings period (POST12)
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: Before trainings period (PRE)
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Functional Magnetic Resonance Imaging (fMRI)
timeFrame: After 12 weeks of trainings period (POST12)
measure: Transcranial magnetic stimulation (TMS)
timeFrame: Before trainings period (PRE)
measure: Transcranial magnetic stimulation (TMS)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Transcranial magnetic stimulation (TMS)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Transcranial magnetic stimulation (TMS)
timeFrame: After 12 weeks of trainings period (POST12)
measure: Electroencephalography (EEG)
timeFrame: Before trainings period (PRE)
measure: Electroencephalography (EEG)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Electroencephalography (EEG)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Electroencephalography (EEG)
timeFrame: After 12 weeks of trainings period (POST12)
measure: Near-infrared spectroscopy (NIRS)
timeFrame: Before trainings period (PRE)
measure: Near-infrared spectroscopy (NIRS)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Near-infrared spectroscopy (NIRS)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Near-infrared spectroscopy (NIRS)
timeFrame: After 12 weeks of trainings period (POST12)
measure: Electromyography (EMG)
timeFrame: Before trainings period (PRE)
measure: Electromyography (EMG)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Electromyography (EMG)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Electromyography (EMG)
timeFrame: After 12 weeks of trainings period (POST12)
measure: Mechanomyography (MMG)
timeFrame: Before trainings period (PRE)
measure: Mechanomyography (MMG)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Mechanomyography (MMG)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Mechanomyography (MMG)
timeFrame: After 12 weeks of trainings period (POST12)
measure: Temperature measurements (Temp)
timeFrame: Before trainings period (PRE)
measure: Temperature measurements (Temp)
timeFrame: After 4 weeks of trainings period (POST4)
measure: Temperature measurements (Temp)
timeFrame: After 8 weeks of trainings period (POST8)
measure: Temperature measurements (Temp)
timeFrame: After 12 weeks of trainings period (POST12)
Secondary outcomes:
Other outcomes:
Locations:
city: Wroclaw
country: Poland
facility: University School of Physical Education in Wroclaw
state: Lower Silesia
Study officials:
affiliation: Wroclaw University of Health and Sport Sciences
name: Katarzyna Kisiel-Sajewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.