Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke

• Status: Recruiting
• Trial end date: 2025-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Carbidopa, levodopa drug combination

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. Arm motor FMA score of <37 (out of 66) at Visit 1

4. 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: wrist extension and finger flexion, each with gravity eliminated

5. At Visit 1, range of motion against gravity must be ≥45 degrees in both the paretic shoulder and elbow (OR, pt must be able to use at least 3 different 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 Montreal Cognitive Assessment (MoCA) score <22

5. A lower score is permitted if due to aphasia and if the patient is specifically allowed by Dr. Cramer

6. Deficits in communication that interfere with reasonable study participation

7. Lacking visual acuity, with or without corrective lens, of 20/40 or better in at least one eye

8. Life expectancy <6 months

9. Pregnant

10. 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

11. Unable to successfully perform all 3 rehabilitation exercise test examples

12. Unable or unwilling to perform study procedures/therapy or attend study visits, or expectation of noncompliance with study procedures/therapy

13. Non-English speaking, such that subject does not speak sufficient English to comply with study procedures

14. Tested positive for COVID-19 during the 10 days prior to planned enrollment; day 0 is the first day of symptoms (if symptomatic) or the day of the positive test (if asymptomatic). For a person who was asymptomatic at time of a positive test and later developed symptoms after testing positive, the 10-day isolation period must start over with day 0 being the first day of symptoms.

15. Was in contact with someone who has COVID-19 in the past 14 days and either (a) is not fully vaccinated against COVID-19, or (b) is fully vaccinated but has symptoms

16. 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 dopaminergic drug or dopamine agonist

17. 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

18. Contraindication to MRI scan