Low Intensity Focused Ultrasound Stimulation in Stroke Patients - Parameter Optimization

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorDuke University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age >=21 years old of any gender or race

First-ever ischemic or hemorrhagic stroke (neuroimaging verified) at least 6 months from the stroke onset of symptoms

Unilateral arm weakness measured by the Fugl-Meyer Upper-Extremity Scale ≤ 62/64

Inducible resting motor threshold and testing motor threshold recorded from an affected upper extremity muscle

Disqualifiers

Bilateral strokes (infarcts and/or hematoma)

Other co-existent neuromuscular disorders affecting upper extremity motor impairment

History of medically uncontrolled depression or other neuropsychiatric disorders despite medications either before or after a stroke that may affect the subject's ability to participate in the study

History of confirmed dementia or taking dementia drugs

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low intensity focused ultrasound stimulation

    Device

    A low-intensity focused ultrasound stimulation

Treatment groups

24 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: ISPPA- 8 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)Experimental treatment 1 intervention
Group B: ISPPA- 4 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)Experimental treatment 1 intervention
Group C: Experimental: ISPPA- 0 W/cm^2 (estimated intracranial spatial-peak pulse-average intensities)Sham comparator 1 intervention
Group D: Pulse repetition frequency(PRF) at 2000 HzExperimental treatment 1 intervention
Group E: Pulse repetition frequency(PRF) at 1000 HzExperimental treatment 1 intervention
Group F: Pulse repetition frequency (PRF) at 500 HzExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Motor sequence learning

Motor sequence learning (MSL) involves predictive processing that results in the anticipation of each component of a sequence of actions. MSL will produce response times and the MSL measure will be the number of responders (i.e., those with ≥20% reduction in the response time).

Time frame
Baseline, immediately after intervention, and 1 hour after intervention
2

Corticospinal excitability

Corticospinal excitability is measured by the peak to peak amplitude of motor evoked potential.

Time frame
Baseline, immediately after intervention, and 1 hour after intervention.

Secondary outcomes

Other outcomes

Sponsors and contacts

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