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

Wroclaw University of Health and Sport Sciences

Status: Unknown

Conditions: Amelia of Upper Limb

Treatments: Behavioral: Computer-aided trainings; Other: No trainings; Behavioral: Computer-aided and mental trainings; Behavioral: Mental trainings

Study type: Interventional

Funder types: Other

Identifiers

NCT04048083

DEC-2011/03/B/NZ7/00588

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 4 patient groups

Patients-MT

Experimental group

Description:

3 Patients with bilateral upper limb congenital transverse deficiency that participated in kinesthetic mental training (MT) of reaching to grasp movements

Treatment:

Behavioral: Mental trainings

Patients-CAT

Experimental group

Description:

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.

Treatment:

Behavioral: Computer-aided trainings

Patients-CAMT

Experimental group

Description:

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).

Treatment:

Behavioral: Computer-aided and mental trainings

Healthy-controls

Active Comparator group

Description:

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

Treatment:

Other: No trainings