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My son, (b)(6), became a complete paraplegic at the age of (b)(6).Three and a half years later, he became the perfect candidate to participate in the external epidural stimulation trial hosted by (b)(6) under the direction of dr.(b)(6).He was examined (b)(6) 2015 and accepted into the trial which started the end of (b)(6).He responded brilliantly.He was able to stand in water unassisted after his first sessions and was able to stand (for up to 30 minutes) after about 2 ½ months.But a price was paid.Often times the test sessions were very painful for him (¿like getting tased for an hour¿) but he would make the trek to the lab in (b)(6), even when he was not feeling well because he was dedicated to the science.He started to have pain in the newly enlivened areas and as the spasticity took root, he would be advised by the team to use his ¿special¿ medicine (marijuana) to aid in calming his body.There was no medical intervention.There was no medical team aligned with the trial so we were at a loss as to what to do.His spasticity became so extreme he broke his foot after he hit a door jamb when his leg shot out and then because his feet would not stay on the footplate, accidentally rolled over his right foot.Nothing was wrong at the time, but at the next session after this occurred his right leg was completely retracted.They stopped the stimulation and instead of sending him to (b)(6) medical for treatment (as dictated by the terms of the consent waiver) he was sent home and it was up to us to find out what was wrong.X -rays were taken but they did not show the break.He was discharged from the trial with no final examination and cast out into an uneducated medical community in the middle of (b)(6) 2015.No one on the medical team could recommend a medical avenue to pursue.From (b)(6) to the end of the year his condition worsened.He was unable to sleep for more than an hour at a time.His appetite disappeared.His pain was unrelenting.The doctors i found to treat him were at a loss.They had never seen symptoms like his.He was finally admitted to his first hospital stay (b)(6) where he was visited by dr.(b)(6) who had nothing to recommend.He then endured 2 more hospital stays as he was falling apart from the lack of sleep and pain.His body was in ¿clench¿ 24 hours a day.The one doctor we did see at (b)(6), dr.(b)(6), ordered a battery of tests.It was only after an mri that it was discovered he had broken his foot in 7 places but by (b)(6) 2016 (when it was identified), it was healed.But the symptoms persisted.Other tests revealed his bladder had greatly increased capacity, presumably as a result of the effects of the trial.He had one spontaneous erection somewhere in the middle of the trial.The time it took for him to do his bowel program was cut in half and he had a vague sensation of being able to ¿push¿ when he first started.He had a constant feeling of wanting to stand.So by that measure, he was responding as the scientists hoped.They even presented him to other scientists at (b)(6) to show off their success.But once he was dismissed from the trial nothing was done to aid in returning him to the condition he was in before he participated.It has been 3 ½ years; he is still completely symptomatic, in pain and internal spasticity (despite the implanting of a baclofen pump).To my knowledge, his response has never been reported to the fda.They continue to do trials around the country and the world.His physical and mental health has been severely compromised.He has been suicidal and has lost his motivation to live.I have full documentation on this horrible journey he has had to navigate.The date this occurred is somewhat fluid.I have reams of medication records including some reports from the actual clinical trial, but it doesn't fit in these boxes.Title of trial: transcutaneous spinal cord stimulation: noninvasive tool for activation of locomotor circuitry.Fda safety report id# (b)(4).
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