Relying on Pharmacotherapy to Improve Motor Gains in Chronic Stroke Survivors

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Spaulding Rehabilitation Hospital
Study ID
NCT07588932
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Telmisartan, Metformin, Cilostazol — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Oct 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Spaulding Rehabilitation HospitalCharlestownMassachusetts02129
Paolo Bonato, PhD
[email protected]
617-952-6388
Federico De Carlo, MS
[email protected]
617-952-6388

Find similar trials in Charlestown, MA

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Spaulding Rehabilitation Hospital· Charlestown, MA

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