Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07220005
Status
Recruiting
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Conditions

  • Arm Weakness as a Consequence of Stroke
  • Stroke
  • Upper Extremity Hemiparesis
  • Upper Extremity Impairments
  • Upper Extremity Weakness

Eligibility Criteria

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

Interventions

  • Low intensity focused ultrasound stimulation — DEVICE
    A low-intensity focused ultrasound stimulation

Study Details

The goal of this research study is to optimize the parameter of Low-Intensity Focused Ultrasound Stimulation (LIFUS) that is most effective in changing cortical excitability and motor learning skills in patients who suffered a stroke. The researchers hope to answer two questions. * with increasing power, would LIFUS be more effective? * with the same power, what LIFUS timing is the best For Aim 1, the study will compare 8, 4 W/cm\^2 to a zero(sham) stimulation to see if higher power is the better. For Aim 2, the study will compare 500 vs 1000 vs 2000 Hz "timing" to see which one is better.

Key Dates

Start date
Dec 10, 2025
Status verified
Dec 2025
Primary completion
May 1, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
    Participant will receive ultrasound stimulation at intensity of 8 W/cm\^2 (estimated intracranial spatial-peak pulse-average intensities, ISPPA).
  • Experimental: ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
    Participant will receive ultrasound stimulation at intensity of ISPPA of 4 W/cm\^2
  • Sham Comparator: Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)
    Participant will receive ultrasound stimulation at ISPPA- 0 W/cm\^2 or sham stimulation
  • Experimental: Pulse repetition frequency(PRF) at 2000 Hz
    each participant will receive LIFUS with pulse repetition frequency at 2000 Hz
  • Experimental: Pulse repetition frequency(PRF) at 1000 Hz
    each participant will receive LIFUS with pulse repetition frequency at 1000 Hz
  • Experimental: Pulse repetition frequency (PRF) at 500 Hz
    Participants will receive LIFUS with pulse repetition frequency at 500 Hz

Primary Outcome Measure

Motor sequence learning [ Time Frame: Baseline, immediately after intervention, and 1 hour after intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710
Megan Gonzalez, MS
[email protected]
919-668-7597

Find similar trials in Durham, NC

By condition
Stroke
By specialty
NeurologyBrain disorders
By research site
Duke University Hospital· Durham, NC

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