Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-25 @ 3:07 AM
NCT ID:
NCT05369533
Eligibility Criteria:
INCLUSION CRITERIA
1. Age 18 years or older
2. Stroke that has been radiologically verified and has time of onset 30 days or less from the time of randomization
3. ARAT score of \<32 (out of 57) at Visit 1
4. At Visit 1, either
1. BBT score with affected arm is at least 1 block in 60 seconds OR
2. There is a visible flicker in each of the following movements with gravity eliminated: wrist extension and finger flexion
5. At Visit 1, either
1. The range of motion against gravity must be ≥45 degrees in both the paretic shoulder and elbow OR
2. the patient must be able to use at least 3 different telerehab system input devices
6. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent)
EXCLUSION CRITERIA
1. A major, active, coexistent neurological or psychiatric disease (e.g., alcoholism or dementia)
2. Major medical disorder that reduces subject's ability to comply with study procedures
3. Severe depression, defined as CES-D score \>24 at screening visit
4. Significant cognitive impairment, defined as presence of either
1. Montreal Cognitive Assessment (MoCA) score \<22 OR
2. Trail Making Test: Part A score ≤14
3. Note that lower scores may be permitted if due to aphasia and if the patient is specifically allowed by Dr. Cramer
5. Deficits in communication that interfere with reasonable study participation
6. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye
7. Life expectancy \<6 months
8. Pregnant
9. 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
10. Unable to successfully perform all 3 rehabilitation exercise test examples
11. Unable or unwilling to perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
12. Non-English or non-Spanish speaking, such that subject does not speak either language sufficiently to comply with study procedures
13. Isolation due to active COVID-19
14. Any contraindication to L-Dopa:
1. 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
2. Known hypersensitivity to any component of Sinemet
3. Narrow-angle glaucoma; if wide-angle glaucoma is present, the patient can only be enrolled with explicit written approval from their ophthalmologist
4. History of melanoma or suspected melanoma
5. Patient is currently taking phenytoin, papaverine, isoniazid, or a dopamine D2 receptor antagonist (such as a phenothiazine, butyrophenone, or risperidone)
6. Currently taking a direct dopaminergic agonist
15. 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05369533
Study Brief:
Protocol Section:
NCT05369533