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Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors

10 juli 2026 bijgewerkt door: Qing Mei Wang, M.D., Spaulding Rehabilitation Hospital

Relying on Pharmacotherapy to Improve Motor Gains of Robot-Assisted Upper-Extremity Rehabilitation in Chronic Stroke Survivors

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.

Studie Overzicht

Toestand

Werving

Conditie

Gedetailleerde beschrijving

The overall objective of the proposed study is to assess the viability of a pharmacotherapy combining Telmisartan, Cilostazol IR, and Metformin ER to affect the motor gains achieved via robot-assisted (RA) upper-extremity (UE) rehabilitation in stroke survivors. The hypothesis underlying the study design is that concomitant administration of Telmisartan, Cilostazol IR, and Metformin ER (herein referred to as "the proposed pharmacotherapy") leads to enhancing motor and non-motor gains observed in stroke survivors in response to RA UE rehabilitation. Participants will take these medications either once a day (QD) or twice a day (BID) as described in the protocol.

To test this hypothesis, we plan to accomplish the following primary and secondary aims.

Primary Aims:

  • 1 To determine if administration of the proposed pharmacotherapy in combination with RA UE rehabilitation leads to greater improvements in UE motor impairment than previously observed in clinical trials relying on RA UE rehabilitation alone.
  • 2 To evaluate potential adverse events when using the proposed pharmacotherapy in combination with RA UE rehabilitation.

Secondary Aim:

#1 To determine if the proposed pharmacotherapy in combination with RA UE rehabilitation improves UE functional ability, health related quality of life, and cognition.

Exploratory Aims:

  • 1 To determine the association between response to the proposed pharmacotherapy and serum-based biomarkers collected at baseline (i.e., evaluation session prior to training), during the first training session (beginning and end of the session), during the last training session (beginning and end of the session), and during the 3-month follow-up evaluation session.
  • 2 To evaluate the retention of motor and cognitive gains at 1-month post-intervention.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Vroege fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

    • Massachusetts
      • Charlestown, Massachusetts, Verenigde Staten, 02129
        • Werving
        • Spaulding Rehabilitation Hospital
        • Contact:
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
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.
Andere namen:
  • Proposed pharmacotherapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Tijdsspanne: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study
The FMA-UE is a widely used, standardized test that measures movement, coordination, and reflexes of the arm, wrist, and hand after a stroke. Scores reflect the degree of motor impairment, with higher scores indicating better motor function (range 0-66).
Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Action Research Arm Test (ARAT)
Tijdsspanne: Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study.
The ARAT is a standardized test of upper limb function after stroke. It assesses the ability to grasp, grip, pinch, and move objects, with higher scores indicating better arm and hand function (range 0 to 57).
Will be assessed at baseline, at 8 weeks, and at the end of the 12-week study.
Stroke Impact Scale (SIS)
Tijdsspanne: Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.
The SIS is a self-reported questionnaire that measures how stroke has affected daily activities, mobility, communication, emotion, memory, and quality of life. Higher scores reflect better function and well-being (range 0 to 100)
Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.
Mini Mental State Exam (MMSE scale)
Tijdsspanne: Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.
An 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language (range 0 to 30).
Will be completed at baseline, at 8 weeks, and at the end of the 12-week study.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: Qing M Wang, MD, PhD, Spaulding Rehabilitation Hospital

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

18 mei 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

9 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

14 mei 2026

Eerst geplaatst (Werkelijk)

15 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Primary and secondary outcome measures will be shared via publications (de-identified individual participant data will be included in the Supplementary Materials section of the manuscript).

IPD-tijdsbestek voor delen

At the time of publication of the manuscript summarizing the results of the study. De-identified individual participant data will be included in the Supplementary Materials section of the manuscript

IPD-toegangscriteria voor delen

We plan to publish an open access manuscript summarizing the results of the study and providing (in the Supplementary Materials section of the manuscript) de-identified individual participant data. Hence, de-identified individual participant data will be accessible by the public at large.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Ja

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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