Critical Periods After Stroke Study (CPASS)

Please see the following reference:

Dromerick, A.W., Edwardson, M., Edwards, D.F., Giannetti, M.L., Barth, J., Brady, K.P., Chan,
E., Tan, M.T., Tamboli, I., Chia, R., Orquiza, M., Padilla, R.M., Cheema, A.K., Mapstone, M.,
Fiandaca, M.S., Federoff, H.J., & Newport, E.L. (2015). Critical Periods after Stroke Study:
Translating animal stroke recovery experiments into a clinical trial. Frontiers in Human
Neuroscience, 9, 002231. PMCID: PMC4413691.

Inclusion Criteria:

- Ischemic or hemorrhagic stroke (with confirmatory neuroimaging) within 28 days of
admission to inpatient rehabilitation (allows those randomized to the early arm to
begin study-related treatment within 30 days)

- Age >21 years

- Able to participate in first study-related treatment session within 30 days of stroke
onset

- Able to participate in all study-related activities, including one year follow up and
blood draws

- Persistent hemiparesis leading to impaired upper extremity function. Hemiparesis as
indicated by NIHSS Motor Arm score ≥ 1

- Recovering moderate motor impairment at the shoulder and elbow or hand such as:

- Proximal UE voluntary activity indicated by a score of ≥ 3 on the upper arm item
of the Motor Assessment Scale - wrist and finger movement is not required

or

- Manual Muscle Test (MMT) score of ≥ 2 on shoulder flexion or abduction and MMT score
of ≥ 2 for any of the following: elbow flexion, elbow extension, wrist flexion, wrist
extension, finger flexion or finger extension.

or

- Active range of motion (AROM) to at least 50% of range in gravity eliminated position
for shoulder flexion or abduction, and for any of the following motions: elbow
flexion, elbow extension, wrist flexion, wrist extension, finger flexion or finger
extension.

- Score of ≤ 8 on the Short Blessed Memory Orientation and Concentration Scale

- Follows 2 step commands

- No upper extremity injury or conditions that limited use prior to the stroke

- Pre-stroke independence: Modified Rankin Score 0 or 1

Exclusion Criteria:

- Inability to give informed consent

- Prior stroke with persistent motor impairment or other disabling neurologic condition
such as multiple sclerosis, parkinsonism, amyotrophic lateral sclerosis (ALS),
dementia requiring medication

- Rapidly improving motor function

- Clinically significant fluctuations in mental status in the 72 hours prior to
randomization

- Hemispatial neglect as determined by >3 errors on the Mesulam Symbol Cancellation Test

- Not independent prior to stroke (determined by scores of <95 on Barthel Index or >1 on
Modified Rankin Scale

- Dense sensory loss indicated by a score of 2 on NIHSS sensory item

- Ataxia out of proportion to weakness in the affected arm as described by a score of ≥
1 on the NIHSS limb ataxia item

- Active or prior psychosis within 2 years

- Active or prior (within 2 years) substance abuse

- Not expected to survive 1 year due to other illnesses (cardiac disease, malignancy,
etc)

- Received upper extremity botulinum toxin within 6 months (other medications do not
exclude)