Clinical trial: Brain and Nerve Stimulation for Hand Muscles in Spinal Cord Injury and ALS (NCT02469675)

Eligibility criteria:
Inclusion Criteria:

          -  Males or females age 21-65 years;

          -  No history of serious neurological injury or disease; OR

          -  Chronic (>12 months since injury) incomplete SCI between levels C2-C8 or diagnosis of
             definite or probable ALS;

          -  Incomplete weakness of left or right hand muscles: score of 3 or 4 (out of 5) on
             manual muscle testing of finger extension, finger flexion, or finger abduction;

          -  Detectable F-wave responses of the left or right abductor pollicis brevis muscle to
             median nerve stimulation;

          -  Detectable motor evoked potentials in left or right abductor pollicis brevis muscle to
             transcranial magnetic stimulation.

        Exclusion Criteria:

          -  Multiple spinal cord lesions;

          -  History of seizures;

          -  Ventilator dependence or patent tracheostomy site;

          -  Use of medications that significantly lower seizure threshold, such as tricyclic
             antidepressants, amphetamines, neuroleptics, dalfampridine, and bupropion;

          -  History of stroke, brain tumor, brain abscess, or multiple sclerosis;

          -  History of moderate to severe head trauma (loss of consciousness for greater than one
             hour or evidence of brain contusion or hemorrhage or depressed skull fracture on prior
             imaging);

          -  History of implanted brain/spine/nerve stimulators, aneurysm clips, ferromagnetic
             metallic implants, or cardiac pacemaker/defibrillator;

          -  Significant coronary artery or cardiac conduction disease;

          -  Recurrent history over the last 6 months of autonomic dysreflexia;

          -  History of bipolar disorder;

          -  History of suicide attempt;

          -  Active psychosis;

          -  Heavy alcohol consumption (greater than equivalent of 5 oz of liquor) within previous
             48 hours;

          -  Open skin lesions over the face, neck, shoulders, or arms;

          -  Pregnancy;

          -  Unsuitable for study participation as determined by study physician.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year.  Over the last few months, he has also noticed weakness in the right upper extremity.  BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor.  Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS.

Patient description (patient's own words): I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my  PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis.

Does the patient match the trial criteria? Entailment