Recovery of Upper Limb Function in Persons With Spinal Cord Injury: Lead-In Study

There is no control group for this study. Participants from both treatment groups:

- Early treatment group = 10 days to 6 months post tSCI and

- Late treatment group = 6 months plus one day post tSCI

will receive one session (60 minutes) of MyndMove therapy, 3 to 5 times per week (only once
per day), to gain 20 hours of intervention (total treatment duration will be 4 to 7 weeks).

Each 1 hour session includes therapy for single-arm or bilateral (left and right upper
extremities) as clinically indicated for each study participant. Over the course of 20 one
hour sessions, participants will progress through the various movement sequences aimed at
regaining natural, unassisted voluntary movement in the affected limb(s). The MyndMove
therapy will be in addition to the conventional upper limb rehabilitation therapy the
participant will be prescribed to undertake at their local institution.

From previous experience, the first signs of function recovery may be expected to emerge two
to four weeks after the onset of the MyndMove therapy program. As soon as the participant
shows signs of recovery of either the voluntary extension or flexion in a stimulated muscle
group, s/he will be encouraged to make an effort to voluntarily produce the movement that was
previously facilitated by FES. As the participant demonstrates improved strength and range of
motion, the FES for that muscle group will be phased out, and moved to another muscle group
that is still paralyzed and needs to be "reactivated". The order in which muscle groups will
be sequentially "reactivated" will be patient dependent.

Muscle reactivation milestones will be monitored and recorded during MyndMove therapy. The
number of MyndMove treatments required to reach each milestone will be recorded. In addition,
the overall time required to reach each milestone will be recorded.

Total duration of study participation, including a follow-up assessment, will be
approximately 4 to 5 months.

Inclusion Criteria:

1. Traumatic incomplete (AIS B-D) C4-C7 SCI

2. Early treatment group = 10 days to 6 months (182 days) post tSCI (note it is expected
that most ppts will be recruited from this group, while at GF Strong)

3. Late treatment group = initiate treatment on or after 6 months plus one day (183
days+) post tSCI

4. SCIM self-care sub-score ≤ 10

5. Able to understand and follow instructions

6. Able to be in a seated position for a least one hour of upper limb therapy

7. Able to attend the study treatment sessions

8. Able to provide informed consent

9. Men and women of the age of majority in their province or state

Exclusion Criteria:

1. Previous history of any other neurological disorder or conditions that may affect
motor response

2. Upper extremity injury or condition prior to SCI that limits the function of the hand
or arm

3. Malignant skin lesion on the affected upper extremity

4. History of seizure disorder not effectively managed by seizure medications

5. An existing electrical stimulation devices (e.g. ICD, Pacemaker, Spinal Stimulation)

6. Rash or open wound at any potential electrode site

7. Denervation of muscles that are targeted by MyndMove

8. Poorly controlled autonomic dysreflexia (as determined by the local site physician)

9. In the judgment of the local site physician, participant has medical complications
that may interfere with the execution of the study

10. Botulinum toxin injection into affected upper extremity within 3 months prior to the
study start. No botulinum toxin injections during the study treatment and follow up
period.

11. Currently enrolled in another upper limb study

12. Enrolled, in the past six months, in a clinical study involving drugs or biologics