Relying on a pill combo to boost arm movement gains after stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial investigates whether a pharmacotherapy combination (Telmisartan, Cilostazol IR, and Metformin ER) taken daily or twice daily can enhance motor recovery during robot-assisted upper-extremity rehabilitation in adults with a history of ischemic stroke. Participants will receive the drug combination alongside standardized robotic therapy to measure changes in motor impairment, functional ability, quality of life, and cognition, as well as monitor safety. The study also explores associations between baseline serum biomarkers and treatment response. Primary goals are to assess greater motor gains and to identify potential adverse effects from the combination with rehabilitation. Secondary and exploratory aims include functional outcomes, quality of life, cognition, and biomarker correlations.

Why it matters

Who can join: the full rules

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 it's running

• Spaulding Rehabilitation Hospital
  Charlestown, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Qing M Wang, MD, PhD — Spaulding Rehabilitation Hospital
• Study coordinator: Madison Costa, OT
• Email: mcosta11@mgb.org
• Phone: 617-952-6388

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.