Recruiting

Early Phase 1

Telmisartan, Cilostazol, MetforminRelying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors

Sponsor:

Spaulding Rehabilitation Hospital

Code:

NCT07588932

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

Interventions

Telmisartan, Metformin, Cilostazol

Study Details

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.

Conditions

Stroke

Study ID

NCT07588932

Start date

May 18, 2026

Status verified date

Jul, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Participants will be instructed to take Telmisartan, Cilostazol IR (immediate release), and Metformin ER (extended release) (herein referred to as "proposed pharmacotherapy") while undergoing robot-assisted upper-extremity training. Participants will take these medications either once a day (QD) or twice a day (BID) as described in the protocol.

Interventions

Telmisartan, Metformin, Cilostazol

Participants will be instructed to take the low dose of the proposed pharmacotherapy (i.e., Telmisartan 20mg QD, Metformin ER 500mg QD, Cilostazol IR 50mg QD) during week 1 and the full dose (i.e., Telmisartan 40mg QD, Metformin ER 500mg BID, Cilostazol IR 50mg BID) starting on week 2. They will continue to take the full dose until completion of the six-week robot assessed upper extremity training period (week 3-8). At the end of this period, they will be instructed to take the low dose of the proposed pharmacotherapy for two more weeks. During the entire study, participants will be monitored for potential side-effects.

Primary outcome measure

Fugl-Meyer Assessment - Upper Extremity (FMA-UE) [ Time Frame: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study ]

Central Contacts and Locations

Central contacts

Madison Costa, OT

617-952-6388 mcosta11@mgb.org

Erin Foley, OT

617-952-6388 efoley14@mgb.org

Locations

Spaulding Rehabilitation Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

Contacts

Paolo Bonato, PhD

617-952-6388 pbonato@mgh.harvard.edu

Federico De Carlo, MS

617-952-6388 fdecarlo@mgb.org

More Information

Sponsor

Spaulding Rehabilitation Hospital

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

Stroke
Rehabilitation
Pharmacotherapy
Robotic therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital on 2026-07-14.