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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04048083
Enrollment
18
Registered
2019-08-07
Start date
2014-03-11
Completion date
2019-12-31
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amelia of Upper Limb

Keywords

bilateral upper limb congenital transverse deficiency, neuroplasticity, sensorimotor cortex, mental training, virtual environment

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.

Interventions

BEHAVIORALMental 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.

BEHAVIORALComputer-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.

BEHAVIORALComputer-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).

OTHERNo trainings

Healthy controls without any kind of training

Sponsors

Wrocław University of Science and Technology
CollaboratorOTHER
Kessler Foundation
CollaboratorOTHER
Nencki Institute of Experimental Biology, Warsaw, Poland
CollaboratorUNKNOWN
Hospital of St. Hedwig in Trzebnica
CollaboratorUNKNOWN
Wroclaw University of Health and Sport Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Magnetic Resonance Imaging (MRI)Before trainings period (PRE)To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Functional Magnetic Resonance Imaging (fMRI)Before trainings period (PRE)To evaluate functional changes in CNS, the fMRI will be used
Transcranial magnetic stimulation (TMS)Before trainings period (PRE)To evaluate excitability of the sensory-motor cortex of the brain.
Electroencephalography (EEG)Before trainings period (PRE)To evaluate functional changes in CNS, the 128-channels EEG will be used.
Near-infrared spectroscopy (NIRS)Before trainings period (PRE)To evaluate functional changes in peripheral nervous system.
Electromyography (EMG)Before trainings period (PRE)To evaluate functional changes in muscles of upper extremity stump
Mechanomyography (MMG)Before trainings period (PRE)To evaluate functional changes in muscles of upper extremity stump
Temperature measurements (Temp)Before trainings period (PRE)To evaluate functional changes in muscles of upper extremity stump

Countries

Poland

Contacts

Primary ContactAndrzej Rokita, PhD
rektor@awf.wroc.pl713473101
Backup ContactJoanna Mencel, MSc
joanna.mencel@awf.wroc.pl71 3473531

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026