Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke

Prior treatment

• Unable or unwilling to perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
• Any contraindication to L-Dopa:
  • Patient is currently taking a monoamine oxidase inhibitor; if the patient took such a drug in the past, it must be discontinued at least two weeks prior to study enrollment
  • Known hypersensitivity to any component of Sinemet
  • Narrow-angle glaucoma; if wide-angle glaucoma is present, the patient can only be enrolled with explicit written approval from their ophthalmologist
  • History of melanoma or suspected melanoma
  • Patient is currently taking phenytoin, papaverine, isoniazid, or a dopamine D2 receptor antagonist (such as a phenothiazine, butyrophenone, or risperidone)
  • Currently taking a direct dopaminergic agonist
• Expectation that subject will not have single domicile address during 6 weeks of therapy that has either Verizon wireless reception or a home WiFi network and that has space for TR system, and is within 30 miles of Cal Rehab

Other illness

• A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
• Major medical disorder that reduces subject's ability to comply with study procedures
• Significant cognitive impairment, defined as presence of either
  • Montreal Cognitive Assessment (MoCA) score \<22 OR
  • Trail Making Test: Part A score ≤14
  • Note that lower scores may be permitted if due to aphasia and if the patient is specifically allowed by Dr. Cramer
• Isolation due to active COVID-19

Other

• Severe depression, defined as CES-D score \>24 at screening visit
• Deficits in communication that interfere with reasonable study participation
• Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
• Life expectancy \<6 months
• Pregnant
• Botox to arms, legs or trunk in the preceding 4 months, or expectation that Botox will be administered to the arm, leg or trunk within 3 months of study enrollment
• Unable to successfully perform all 3 rehabilitation exercise test examples
• Non-English or non-Spanish speaking, such that subject does not speak either language sufficiently to comply with study procedures

• Age 18 years or older
• Stroke that has been radiologically verified and has time of onset 30 days or less from the time of randomization
• ARAT score of \<32 (out of 57) at Visit 1
• At Visit 1, either
  • BBT score with affected arm is at least 1 block in 60 seconds OR
  • There is a visible flicker in each of the following movements with gravity eliminated: wrist extension and finger flexion
• At Visit 1, either
  • The range of motion against gravity must be ≥45 degrees in both the paretic shoulder and elbow OR
  • the patient must be able to use at least 3 different telerehab system input devices
• Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)