Dopaminergic Enhancement of Rehabilitation Therapy Early After Stroke

NCT05369533 | Completed Phase 1 Results FDA Device

• 1 other identifier: 22-000104
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; rehabilitation; telehealth; dopamine

Outcome Measures

Primary Outcomes (1)

• Change in Action Research Arm Test Score From Baseline to 3 Months

  Measures arm function using a scale that runs from 0 to 57 points, with higher scores indicating greater arm function.

  Measured at baseline and 3 months later

Secondary Outcomes (1)

• Change in Arm Motor Fugl-Meyer Scale From Baseline to 3 Months

  Measured at baseline and 3 months later

Study Arms (3)

Telerehabilitation + Sinemet

ACTIVE COMPARATOR

Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Sinemet is taken one hour before starting TR, for the first 18 sessions.

Device: Telerehabilitation; Drug: Sinemet Pill

Telerehabilitation + Placebo

PLACEBO COMPARATOR

Patients will receive 36 telerehabilitation sessions targeting arm motor function. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6-8 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently. Placebo is taken one hour before starting TR, for the first 18 sessions.

Device: Telerehabilitation; Drug: Placebo

Usual care

NO INTERVENTION

Participants in the usual care group will receive no TR or study pill, but will continue with the recommendations made by their care team. All participants will be offered TR at the end of the study.

Interventions

Telerehabilitation DEVICE

The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. TR sessions will be a combination of games, exercises, stroke education, assessments, in addition to videoconferencing with therapists to discuss progress, issues, goals, and changes to the treatment plan.

Telerehabilitation + Placebo; Telerehabilitation + Sinemet

Sinemet Pill DRUG

Sinemet 25/100 will be taken 1 hour prior to TR, for the first 18 sessions.

Telerehabilitation + Sinemet

Placebo DRUG

Placebo will be taken 1 hour prior to TR, for the first 18 sessions.

Telerehabilitation + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

California Rehabilitation Institute

Los Angeles, California, 90067, United States

Location

Related Publications (7)

• Dodakian L, McKenzie AL, Le V, See J, Pearson-Fuhrhop K, Burke Quinlan E, Zhou RJ, Augsberger R, Tran XA, Friedman N, Reinkensmeyer DJ, Cramer SC. A Home-Based Telerehabilitation Program for Patients With Stroke. Neurorehabil Neural Repair. 2017 Oct-Nov;31(10-11):923-933. doi: 10.1177/1545968317733818. Epub 2017 Oct 26.

  PMID: 29072556 BACKGROUND

• Chen Y, Abel KT, Janecek JT, Chen Y, Zheng K, Cramer SC. Home-based technologies for stroke rehabilitation: A systematic review. Int J Med Inform. 2019 Mar;123:11-22. doi: 10.1016/j.ijmedinf.2018.12.001. Epub 2018 Dec 11.

  PMID: 30654899 BACKGROUND

• Cramer SC, Dodakian L, Le V, See J, Augsburger R, McKenzie A, Zhou RJ, Chiu NL, Heckhausen J, Cassidy JM, Scacchi W, Smith MT, Barrett AM, Knutson J, Edwards D, Putrino D, Agrawal K, Ngo K, Roth EJ, Tirschwell DL, Woodbury ML, Zafonte R, Zhao W, Spilker J, Wolf SL, Broderick JP, Janis S; National Institutes of Health StrokeNet Telerehab Investigators. Efficacy of Home-Based Telerehabilitation vs In-Clinic Therapy for Adults After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2019 Sep 1;76(9):1079-1087. doi: 10.1001/jamaneurol.2019.1604.

  PMID: 31233135 BACKGROUND

• Chen Y, Chen Y, Zheng K, Dodakian L, See J, Zhou R, Chiu N, Augsburger R, McKenzie A, Cramer SC. A qualitative study on user acceptance of a home-based stroke telerehabilitation system. Top Stroke Rehabil. 2020 Mar;27(2):81-92. doi: 10.1080/10749357.2019.1683792. Epub 2019 Nov 4.

  PMID: 31682789 BACKGROUND

• Cramer SC, Dodakian L, Le V, McKenzie A, See J, Augsburger R, Zhou RJ, Raefsky SM, Nguyen T, Vanderschelden B, Wong G, Bandak D, Nazarzai L, Dhand A, Scacchi W, Heckhausen J. A Feasibility Study of Expanded Home-Based Telerehabilitation After Stroke. Front Neurol. 2021 Feb 3;11:611453. doi: 10.3389/fneur.2020.611453. eCollection 2020.

  PMID: 33613417 BACKGROUND

• Paik SM, Cramer SC. Predicting motor gains with home-based telerehabilitation after stroke. J Telemed Telecare. 2023 Dec;29(10):799-807. doi: 10.1177/1357633X211023353. Epub 2021 Jun 22.

  PMID: 34156873 BACKGROUND

• Pearson-Fuhrhop KM, Cramer SC. Pharmacogenetics of neural injury recovery. Pharmacogenomics. 2013 Oct;14(13):1635-43. doi: 10.2217/pgs.13.152.

  PMID: 24088134 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation; carbidopa, levodopa drug combination

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Steven Cramer
• Organization: University of California, Los Angeles

SCCramer@mednet.ucla.edu

424-522-7874

Study Officials

• Steven Cramer

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded, placebo controlled, randomized. Participants and investigators will be blinded to the study group allocations (placebo vs Sinemet).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Patients are randomized to TR + placebo, TR + Sinemet, or usual care

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 11, 2022
• Study Start: August 1, 2022
• Primary Completion: March 11, 2024
• Study Completion: March 11, 2024
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: likely starting 1-2 years after study completion, lasting for several years thereafter
• Access Criteria: Data will be shared using common data formats with appropriate personnel

Locations

US (1)