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

Not Applicable

• Conditions: Amelia of Upper Limb

• Registration Number: NCT04048083
• Lead Sponsor: Wroclaw University of Health and Sport Sciences

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.

Study Timeline

• Study Start: 2014-03-11
• Primary Completion: 2016-09-09
• Status Verified: 2019-08
• Study First Submitted: 2019-08-02
• Study First Submitted QC: 2019-08-02
• Last Update Submitted: 2019-08-02
• Study First Posted: 2019-08-07
• Last Update Posted: 2019-08-07
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Electroencephalography (EEG)	After 12 weeks of trainings period (POST12)	To evaluate functional changes in CNS, the 128-channels EEG will be used.
Electromyography (EMG)	After 12 weeks of trainings period (POST12)	To evaluate functional changes in muscles of upper extremity stump
Mechanomyography (MMG)	After 12 weeks of trainings period (POST12)	To evaluate functional changes in muscles of upper extremity stump
Functional Magnetic Resonance Imaging (fMRI)	After 12 weeks of trainings period (POST12)	To evaluate functional changes in CNS, the fMRI will be used
Near-infrared spectroscopy (NIRS)	After 12 weeks of trainings period (POST12)	To evaluate functional changes in peripheral nervous system.
Temperature measurements (Temp)	After 12 weeks of trainings period (POST12)	To evaluate functional changes in muscles of upper extremity stump
Magnetic Resonance Imaging (MRI)	After 12 weeks of trainings period (POST12)	To evaluate structural changes in central nervous system (CNS) the MRI method will be used
Transcranial magnetic stimulation (TMS)	After 12 weeks of trainings period (POST12)	To evaluate excitability of the sensory-motor cortex of the brain.

Trial Locations

Locations (1)

University School of Physical Education in Wroclaw; 🇵🇱 Wroclaw, Lower Silesia, Poland