Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors
ConditionStroke
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age21-80
SponsorSpaulding Rehabilitation Hospital
About this trial
The goal of this trial is to study if the concomitant administration of Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) can help stroke survivors make greater gains in movement and recovery during robot-assisted arm and hand rehabilitation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults between 21 and 80 years of age.
History of ischemic stroke.
Stroke occurred at least six months prior to recruitment.
Moderate to severe UE impairment (FMA-UE score between 15 and 40)
Disqualifiers
Contraindications to the pharmacotherapy (e.g., heart failure, known medication reaction or interactions with ongoing medication regimen).
Taking dual antiplatelet therapy (e.g., Aspirin+Plavix) and/or other anticoagulation medications (e.g., Eliquis, coumadin) that cannot safely be modified or discontinued (as determined by the participant's primary care physician or by the medical monitor).
Clinically significant somnolence and/or depression that would hinder active participation in motor training sessions.
Taking any medication that the study physician determines to have a significant drug-drug interaction with Telmisartan, Cilostazol, and/or Metformin.
Trial design
Design model
Single group
Treatments tested in this trial
Telmisartan, Metformin, Cilostazol
DrugParticipants will be instructed to take the low dose of the proposed pharmacotherapy (i.e., Telmisartan 20mg QD, Metformin ER 500mg QD, Cilostazol IR 50mg QD) during week 1 and the full dose (i.e., Telmisartan 40mg QD, Metformin ER 500mg BID, Cilostazol IR 50mg BID) starting on week 2. They will continue to take the full dose until completion of the six-week robot assessed upper extremity training period (week 3-8). At the end of this period, they will be instructed to take the low dose of the proposed pharmacotherapy for two more weeks. During the entire study, participants will be monitored for potential side-effects.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
The FMA-UE is a widely used, standardized test that measures movement, coordination, and reflexes of the arm, wrist, and hand after a stroke. Scores reflect the degree of motor impairment, with higher scores indicating better motor function (range 0-66).
Time frame
Will be assessed at baseline, at 8 weeks, and at the end of the 12-week studySecondary outcomes
1
Action Research Arm Test (ARAT)
The ARAT is a standardized test of upper limb function after stroke. It assesses the ability to grasp, grip, pinch, and move objects, with higher scores indicating better arm and hand function (range 0 to 57).
Time frame
Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study.2
Stroke Impact Scale (SIS)
The SIS is a self-reported questionnaire that measures how stroke has affected daily activities, mobility, communication, emotion, memory, and quality of life. Higher scores reflect better function and well-being (range 0 to 100)
Time frame
Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.3
Mini Mental State Exam (MMSE scale)
An 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language (range 0 to 30).
Time frame
Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Spaulding Rehabilitation Hospital
Lead sponsor
Neuro-Innovators, Inc.
Collaborator
Source ClinicalTrials.gov