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Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors

14 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Prima fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Madison Costa, OT
  • Numero di telefono: 617-952-6388
  • Email: mcosta11@mgb.org

Backup dei contatti dello studio

Luoghi di studio

    • Massachusetts
      • Charlestown, Massachusetts, Stati Uniti, 02129
        • Spaulding Rehabilitation Hospital
        • Contatto:
        • Contatto:
          • Federico De Carlo, MS
          • Numero di telefono: 617-952-6388
          • Email: fdecarlo@mgb.org

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altri nomi:
  • Proposed pharmacotherapy

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Action Research Arm Test (ARAT)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Collaboratori

Investigatori

  • Investigatore principale: Qing M Wang, MD, PhD, Spaulding Rehabilitation Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

18 maggio 2026

Completamento primario (Stimato)

31 ottobre 2027

Completamento dello studio (Stimato)

31 dicembre 2028

Date di iscrizione allo studio

Primo inviato

9 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 maggio 2026

Primo Inserito (Effettivo)

15 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Descrizione del piano IPD

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).

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Telmisartan, Metformin, Cilostazol

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