Phase 2
N=25
Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT05369533 ↗Enrolled (actual)
25
Serious AEs
32.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Action Research Arm Test Score From Baseline to 3 Months — 23.5; 24; 15.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Telerehabilitation (Device); Sinemet Pill (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Action Research Arm Test Score From Baseline to 3 Months |
23.5; 24; 15.1 | — |
| SECONDARY Change in Arm Motor Fugl-Meyer Scale From Baseline to 3 Months |
23.8; 21.9; 12 | — |
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 that happened in the past 30 days will be randomized into one of three groups: [1] TR and placebo (a sugar pill) on top of usual care; [2] TR and a medication (Sinemet 25/100) on top of usual care; [3] or usual care alone (no TR and no pill, but people in this group will be offered TR once the study is done). TR consists of 70 minutes/day of activities targeting arm function, 6 days a week for 6 weeks.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT05369533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.