Study: NCT02467023

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Muscle stimulation with Niveus medical stimulator
Description: Subjects will be treated five days per week, for 30 minutes each session. Muscle stimulation will be conducted for four seconds every 15 seconds, thus the subjects will undergo four stimulations per minute. Muscle stimulation will be adjusted until there is a visible or palpable bilateral quadriceps contraction.

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: measurement of maximal isometric twitch strength
Description: Quadriceps strength will be measured on the initial day of study approximately every seven days thereafter and on the final day of study participation. For this measurement, patients will remain supine in their bed and the dominant leg will be placed on a frame that will hold the knee at a 60° angle. A cuff will be placed around the ankle and connected to an electronic dynamometer that will record the force generated during the stimulation. The muscle will be stimulated to contract with magnetic stimulators placed over the body of the quadriceps muscle and stimulated at 100% of power output.

Intervention type: DEVICE
Group type: ACTIVE_COMPARATOR
Intervention: measurement of maximal isometric twitch strength
Description: Quadriceps strength will be measured on the initial day of study approximately every seven days thereafter and on the final day of study participation. For this measurement, patients will remain supine in their bed and the dominant leg will be placed on a frame that will hold the knee at a 60° angle. A cuff will be placed around the ankle and connected to an electronic dynamometer that will record the force generated during the stimulation. The muscle will be stimulated to contract with magnetic stimulators placed over the body of the quadriceps muscle and stimulated at 100% of power output.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Muscle Biopsy
Description: This procedure will be done at the end of participation in the study.The biopsy will be performed with a sterile needle, which will be inserted through the skin. A skin incision (approximately 1/4 long) will be made in order to insert the needle. The biopsy procedure yields two small pieces of muscle tissue (200 mg total), each about half the size of the eraser on a pencil. After the biopsy is taken, the incision will be closed using a steri-strip bandage (no stitches are required), and a sterile dressing will be placed over the site to reduce the risk of bleeding.

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Muscle Biopsy
Description: This procedure will be done at the end of participation in the study.The biopsy will be performed with a sterile needle, which will be inserted through the skin. A skin incision (approximately 1/4 long) will be made in order to insert the needle. The biopsy procedure yields two small pieces of muscle tissue (200 mg total), each about half the size of the eraser on a pencil. After the biopsy is taken, the incision will be closed using a steri-strip bandage (no stitches are required), and a sterile dressing will be placed over the site to reduce the risk of bleeding.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Muscle Biopsy Medication: Lidocaine
Description: Biopsy samples will be obtained under local anesthesia (up to 20 milliliters of 1% Lidocaine administered subcutaneously). Lidocaine, a drug to numb your pain will be injected into the skin and muscle tissue. The injection of the numbing medication will be slightly painful and is similar to receiving a shot into your arm for a vaccination. This medication numbs the skin and muscle so that you do not feel pain when the biopsy is obtained.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Muscle Biopsy Medication: Lidocaine
Description: Biopsy samples will be obtained under local anesthesia (up to 20 milliliters of 1% Lidocaine administered subcutaneously). Lidocaine, a drug to numb your pain will be injected into the skin and muscle tissue. The injection of the numbing medication will be slightly painful and is similar to receiving a shot into your arm for a vaccination. This medication numbs the skin and muscle so that you do not feel pain when the biopsy is obtained.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Muscle Biopsy Medication: Versed
Description: Prior to starting the muscle biopsy, you can receive a drug, Versed, to help you relax during the procedure. 1-2 milligrams of Versed will be administered intravenously (in the vein) through an existing peripheral or central intravenous catheter. This procedure drug is given as needed and can be repeated one time as needed.