Open Actively Recruiting

Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke

About

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 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.

Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase I/II

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
  • Arm motor FMA score of <37 (out of 66) 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: wrist extension and finger flexion, each with gravity eliminated
  • 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)
  • 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 Montreal Cognitive Assessment (MoCA) score <22
  • A lower score is 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 20/40 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 speaking, such that subject does not speak sufficient English to comply with study procedures
  • 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.
  • 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
  • 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 dopaminergic drug or dopamine 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
  • Contraindication to MRI scan

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Study Stats
Protocol No.
22-000104
Category
Brain/Neurological Diseases
Principal Investigator
Contact
LORIE BRINKMAN
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05369533
For detailed technical eligibility, visit ClinicalTrials.gov.