Restoration of Standing and Walking With ISMS in Humans

Two study volunteers who are completely paralyzed (T2-8 region) to undergo an evaluation of
ISMS during an otherwise normal thoracic spinal surgical procedure.

The potential volunteers will be asked to review and sign a screening consent form prior to
initial screening. This is to ensure that the ideal two patients are selected for this study
and that foreseeable issues are identified and risks minimized for the volunteers. The
subjects must have a stable, complete spinal cord injury involving their upper thoracic
spinal cord (T2-8 region), and are otherwise planning to undergo a spine surgery involving
the lower thoracic spinal cord.

Subjects who have volunteered for this study will undergo their intended spinal surgery by
the clinical team. The usual indications for undergoing such a surgery is either to correct a
deformity involving the lower thoracic region, or stabilizing the lower thoracic region due
to chronic instability from degenerative disease. The surgery intended for clinical treatment
must involve exposure of the T9-T12 spinal lamina. However, exposure of the spinal cord
through a dural opening would not normally be performed in this clinical scenario. The
experimental portion of the surgery begins then, with a laminectomy of T9-T12 and exposure of
the spinal cord through a durotomy using standard neurosurgical techniques for spinal cord
exposure. The spinal cord in this region will then be mapped and stimulated using ISMS and
the effects on the legs measured to determine if the circuitry exists to potentially allow
standing or walking through the use of ISMS. The research requests subjects to specifically
allow 2 hours of extra time during the routine spinal surgery to perform this study.

Inclusion Criteria:

1. Age 18-50 years old; male or female (no preference).

2. Complete paraplegia (ASIA A classification) as a result of a spinal cord injury
between the levels of T2-8.

i. No motor or sensory function below the level of injury as determined by a
physician.

ii. No voluntary bladder function - defined as the inability to sense bladder fullness
or voluntary contraction of the bladder (meets criteria for no sacral sparing).

iii. Stable paraplegia.

3. Patients with involuntary spasms are allowed. However, spasticity must be less than
Ashworth 4 or spasm rating of 3 or less.

4. History of spinal cord injury greater than 1 year.

5. Intent to undergo spine surgery involving exposure of at least T9-T12 vertebral
lamina.

6. MRI studies performed within the past year showing presence of spinal cord between
T8-L1 with reasonable normal anatomical shape. No chronic infections.

7. Ability to travel to Vanderbilt Medical Center.

Exclusion Criteria:

1. Acute medical conditions that are under active treatment. Examples include active
urinary tract infection, respiratory illness, decubital ulcers, fractures, upper
extremity injury, back pain.

2. Pregnancy.

3. Presence of a neurostimulator, bladder stimulator, cardiac stimulator or other
electrical stimulator device implant.

4. Inability to transfer from wheel chair to chair or bed.

5. Inability to tolerate 1 hour of physical activity such as gait training in a harness.

6. Severe depression requiring active medical treatment or counseling.

7. Cognitive impairment that places the study volunteer under the 6th grade reading
level.

8. Inability to provide consent.

9. Intradural or extradural masses compressing or displacing the spinal cord between
T8-L1 region.

10. Significant change in motor or sensory function over the previous year.

11. History of spinal cord injury less than 1 year.

12. Previous laminectomy and intradural spinal cord procedure involving the region of
T9-T12.

13. Patients with involuntary spasms with rigidity more than Ashworth 4 or spasm rating of
3 or more.