NCT07588932 · Spaulding Rehabilitation Hospital
Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors
What this study is about
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 treatment group$1 and hand rehabilitation.
View original scientific description
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.
Interventions
DRUG
Telmisartan, Metformin, Cilostazol
Participants 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.
Primary outcome measures
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time frame: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
- MMSE score \>=20 and being able to safely follow three-step commands.
Exclusion criteria
- 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.
- Taking Telmisartan, Cilostazol, and/or Metformin in a dose that is different from the one used in the study and that cannot be adjusted to match the study dose (as determined by the participant's primary care physician or by the medical monitor).
- Taking medications with equivalent clinical effect (e.g., BP control) to Telmisartan, Cilostazol, and/or Metformin and that cannot be replaced by Telmisartan, Cilostazol, and/or Metformin (as determined by the participant's primary care physician or by the medical monitor).
- A body mass index (BMI) below 25 (as the proposed pharmacotherapy could cause hypoglycemia in participants with normal-low BMI).
- Severe musculoskeletal pathology or recent fractures affecting the impaired UE that would prevent safe use of the rehabilitation robotic system.
- Previous diagnosis of neurological diseases other than stroke that would have a negative impact on the response to the rehabilitation intervention (e.g., severe dystonia affecting the UE) or would prevent safe participation in RA UE training (e.g., uncontrolled seizures).
- Moderate to severe disability due to migraines as determined using the Migraine Disability Assessment test (score \> 10).
- Severe spasticity (Modified Ashworth Scale for spasticity ≥ 3 for UE muscles) that would prevent safe use of the robotic system utilized during training.
- Undergoing Botox treatment for pain/spasticity related to the affected upper extremity, in the 4 months prior to enrollment or during the study period.
- Cerebellar and/or hemorrhagic stroke.
- Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally.
- Visual impairments that would prevent proper use of interactive on-screen games during RA UE training.
- Severe hemispatial neglect as assessed using the Line Bisection Test (missed lines \>2).
- Severely impaired trunk control that would prevent sitting safely on a chair without arms.
- Individuals who present with the following on the impaired UE: open wounds, fragile skin, and under contact precautions due to an active infection.
- Participation in another therapy focused on the recovery of the impaired UE.
- Subjects with cardiac pacemakers, electronic pumps, or any other implanted medical devices that are not US-certified (and hence might be affected by the electromagnetic interference generated by the robot).
- Any condition that would prevent proper/safe use of the robotic system, such as proprioceptive deficits that impair the ability to process haptic or visual feedback, or unstable shoulder joint as assessed by physical examination.
- Current pregnancy.
Where
- Charlestown, Massachusetts
Collaborators
Neuro-Innovators, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations