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Could a pill trio supercharge stroke rehab?

NCT ID NCT07588932

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jul 15, 2026 · Updated 4 times

Summary

This early-phase trial aims to see if taking a combination of three common drugs (Telmisartan, Metformin, and Cilostazol) can help chronic stroke survivors gain more movement in their arms and hands during robot-assisted therapy. Fifty adults who had an ischemic stroke at least six months ago and have moderate to severe arm impairment will participate. The study will compare motor gains between those taking the drugs plus rehab and historical data from rehab alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Telmisartan, Metformin, and Cilostazol (a combination of blood pressure, diabetes, and blood flow medications)
What this could lead to
If it works, this could point toward a way to improve arm and hand function in people who have had a stroke, making rehabilitation more effective.
What could go wrong
This is a very early (Phase 1) trial with only 50 people, so results may not apply widely. The drug combo may cause side effects or not improve recovery more than rehab alone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Spaulding Rehabilitation Hospital

    RECRUITING

    Charlestown, Massachusetts, 02129, United States

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