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Study of Telmisartan, Metformin, and Cilostazol for Stroke Recovery

This study is looking at whether a combination of three existing medications—Telmisartan, Metformin, and Cilostazol—can help people who have had a stroke improve their arm and hand movement more effectively when combined with robot-assisted rehabilitation. The goal is to see if these drugs can lead to greater recovery in movement. You might be able to join if you are between 21 and 80 years old, had an ischemic stroke at least six months ago, and have moderate to severe arm weakness. The study will measure success by looking at changes in your arm and hand function using a tool called the Fugl-Meyer Assessment - Upper Extremity (FMA-UE). The current status of this study is unclear, and it plans to enroll 50 participants.

Study design
This interventional study plans to enroll 50 participants. Participants will take a low dose of the study medications for one week, then a full dose for the remainder of the study.
What's involved
You would take the study medications daily for 12 weeks. Your arm and hand function will be assessed at the beginning, at 8 weeks, and at the end of the 12-week study.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be assessed at the end of the 12-week study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07588932

Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors

Recruiting
EARLY_PHASE1Ages 21–80InterventionalTreatment
Spaulding Rehabilitation Hospital
~50 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Telmisartan, Metformin, Cilostazol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Measured over Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study

Conditions

Stroke

Explore related trials

Ischemic Stroke

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Qing M Wang, MD, PhD · PRINCIPAL_INVESTIGATOR · Spaulding Rehabilitation Hospital

Who to contact

Madison Costa, OT
[email protected]
617-952-6388
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Fugl-Meyer Assessment - Upper Extremity (FMA-UE)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).