Skip to main content
Clinical Trials/NCT04048083
NCT04048083
Unknown
Not Applicable

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

Wroclaw University of Health and Sport Sciences1 site in 1 country18 target enrollmentMarch 11, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amelia of Upper Limb
Sponsor
Wroclaw University of Health and Sport Sciences
Enrollment
18
Locations
1
Primary Endpoint
Transcranial magnetic stimulation (TMS)
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 11, 2014
End Date
December 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Wroclaw University of Health and Sport Sciences
Responsible Party
Principal Investigator
Principal Investigator

Jaroslaw Marusiak

Co-Investigator

Wroclaw University of Health and Sport Sciences

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Transcranial magnetic stimulation (TMS)

Time Frame: After 12 weeks of trainings period (POST12)

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

Electroencephalography (EEG)

Time Frame: After 12 weeks of trainings period (POST12)

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

Electromyography (EMG)

Time Frame: After 12 weeks of trainings period (POST12)

To evaluate functional changes in muscles of upper extremity stump

Mechanomyography (MMG)

Time Frame: After 12 weeks of trainings period (POST12)

To evaluate functional changes in muscles of upper extremity stump

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

Near-infrared spectroscopy (NIRS)

Time Frame: After 12 weeks of trainings period (POST12)

To evaluate functional changes in peripheral nervous system.

Temperature measurements (Temp)

Time Frame: After 12 weeks of trainings period (POST12)

To evaluate functional changes in muscles of upper extremity stump

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

Study Sites (1)

Loading locations...

Similar Trials