Non-invasive VNS in Stroke Recovery

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06761404
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • taVNS — DEVICE
    Experimental. The current will be increased gradually for both sham and real stimulation at the beginning of the 90-minute stimulation to lessen the itchy/numb skin sensation and to create the same skin sensation for subject blinding.

Study Details

To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery

Key Dates

Start date
Apr 15, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Sham Stimulation
    Same procedure as with the active stimulation using the device's sham settings to elicit the same cutaneous sensation as the other stimulation conditions..
  • Experimental: taVNS
    Weak current (up to 0.8-4 mA) will be delivered using pulses according to standard protocol during each motor task for up to 90-minutes through surface electrodes which will be administered using the intensity identified as resulting in well tolerated skin sensation and best motor performance during our initial testing session.

Primary Outcome Measure

To evaluate feasibility and effectiveness of non-invasive VNS to enhance stroke recovery [ Time Frame: [Time Frame: Baseline, post intervention (week 6), post intervention (week 12), and follow up for the sham crossover group (week 18)] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Research InstituteHoustonTexas77030
Darrel Cleere
[email protected]
713-441-3770

Find similar trials in Houston, TX

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Houston Methodist Research Institute· Houston, TX

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