NCT07588932 Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 50 participants in total. It began in 2026-05-18 with a primary completion date of 2027-12-31.

Brief Summary

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

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.

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