Status:
COMPLETED
Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke
Lead Sponsor:
University of California, Los Angeles
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study explores the effects of telerehabilitation and a study medication on rehabilitation outcomes in patients with stroke resulting in arm weakness. Patients with arm weakness due to a stroke th...
Detailed Description
This is a randomized, double-blind, placebo-controlled study that involves the use of telerehabilitation to deliver additional therapy for persons with stroke. Participants with arm weakness due to a ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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)
- EXCLUSION CRITERIA
- 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
- Severe depression, defined as CES-D score \>24 at screening visit
- 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
- 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
- Unable or unwilling to perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy
- Non-English or non-Spanish speaking, such that subject does not speak either language sufficiently to comply with study procedures
- Isolation due to active COVID-19
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 11 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT05369533
Start Date
August 1 2022
End Date
March 11 2024
Last Update
March 24 2025
Active Locations (1)
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1
California Rehabilitation Institute
Los Angeles, California, United States, 90067