Telmisartan, Cilostazol, and Metformin for Stroke Recovery
Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors
Recruiting
Early Phase 1Interventional Study
Stroke
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
21 – 80
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Spaulding Rehabilitation Hospital · Other
Who this trial is looking for
This trial is looking for stroke survivors aged 21 to 80 who want to improve their movement after rehabilitation. Those who join will take specific medications along with robot-assisted therapy to help in their recovery.
Are You a Good Fit for This Trial?
Rules you outSevere spasticityCerebellar strokeHemorrhagic strokeSevere aphasiaSevere hemispatial neglectSevere trunk control issues
You may be able to join if
I am between 21 and 80 years old.
I have a history of ischemic stroke.
My stroke happened at least six months ago.
I have moderate to severe impairment in my upper extremity.
I can follow three-step commands.
You may not be able to join if
I have heart failure or a severe reaction to medications.
I take blood thinners that cannot be changed.
I have severe depression that affects my participation.
I take medications that interact with the study drugs.
I recently had Botox treatment for my upper arm.
I have severe visual impairments affecting my therapy.
I am currently pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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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.
Exclusi…
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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