UnknownNot Applicable

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

Poland18 participantsStarted 2014-03-11

Plain-language 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.

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 Criteri…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Magnetic Resonance Imaging (MRI)

Timeframe: Before trainings period (PRE)

Magnetic Resonance Imaging (MRI)

Timeframe: After 4 weeks of trainings period (POST4)

Magnetic Resonance Imaging (MRI)

Timeframe: After 8 weeks of trainings period (POST8)

Magnetic Resonance Imaging (MRI)

Timeframe: After 12 weeks of trainings period (POST12)

Functional Magnetic Resonance Imaging (fMRI)

Timeframe: Before trainings period (PRE)

Functional Magnetic Resonance Imaging (fMRI)

Timeframe: After 4 weeks of trainings period (POST4)

Functional Magnetic Resonance Imaging (fMRI)

Timeframe: After 8 weeks of trainings period (POST8)

Trial details

NCT IDNCT04048083

SponsorWroclaw University of Health and Sport Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09-09

Contact for this trial

Andrzej Rokita, PhD

713473101 rektor@awf.wroc.pl

View on ClinicalTrials.gov More Amelia of Upper Limb trials

Plain-language summary

Who can participate

Age range

18 Years – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Magnetic Resonance Imaging (MRI)

Timeframe: Before trainings period (PRE)

Magnetic Resonance Imaging (MRI)

Timeframe: After 4 weeks of trainings period (POST4)

Magnetic Resonance Imaging (MRI)

Timeframe: After 8 weeks of trainings period (POST8)

Magnetic Resonance Imaging (MRI)

Timeframe: After 12 weeks of trainings period (POST12)

Functional Magnetic Resonance Imaging (fMRI)

Timeframe: Before trainings period (PRE)

Functional Magnetic Resonance Imaging (fMRI)

Timeframe: After 4 weeks of trainings period (POST4)

Functional Magnetic Resonance Imaging (fMRI)

Timeframe: After 8 weeks of trainings period (POST8)